Comparing Video-Based, Telehealth-Delivered Exercise and Weight Loss Programs With Online Education on Outcomes of Knee Osteoarthritis : A Randomized Trial.

BACKGROUND: Scalable knee osteoarthritis programs are needed to deliver recommended education, exercise, and weight loss interventions. OBJECTIVE: To evaluate two 6-month, telehealth-delivered exercise programs, 1 with and 1 without dietary intervention. DESIGN: 3-group, parallel randomized (5:5:2) trial. (Australian New Zealand Clinical Trials Registry: ACTRN12618000930280). SETTING: Australian private health insurance members. PARTICIPANTS: 415 persons with symptomatic knee osteoarthritis and a body mass index between 28 and 40 kg/m2 who were aged 45 to 80 years. INTERVENTION: All groups received access to electronic osteoarthritis information (control). The exercise program comprised 6 physiotherapist consultations via videoconference for exercise, self-management advice, and behavioral counseling, plus exercise equipment and resources. The diet and exercise program included an additional 6 dietitian consultations for a ketogenic very-low-calorie diet (2 formulated meal replacements and a low-carbohydrate meal daily) followed by a transition to healthy eating, as well as nutrition and behavioral resources. MEASUREMENTS: Primary outcomes were changes in knee pain (numerical rating scale [NRS] of 0 to 10, higher indicating worse) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]; scale, 0 to 68, higher indicating worse) at 6 months (primary time point) and 12 months. Secondary outcomes were weight, physical activity, quality of life, mental health, global change, satisfaction, willingness to have surgery, orthopedic appointments, and knee surgery. RESULTS: A total of 379 participants (91%) provided 6-month primary outcomes, and 372 (90%) provided 12-month primary outcomes. At 6 months, both programs were superior to control for pain (between-group mean difference in change on NRS: diet and exercise, -1.5 [95% CI, -2.1 to -0.8]; exercise, -0.8 [CI, -1.5 to -0.2]) and function (between-group mean difference in change on WOMAC: diet and exercise, -9.8 [CI, -12.5 to -7.0]; exercise, -7.0 [CI, -9.7 to -4.2]). The diet and exercise program was superior to exercise (pain, -0.6 [CI, -1.1 to -0.2]; function, -2.8 [CI, -4.7 to -0.8]). Findings were similar at 12 months. LIMITATION: Participants and clinicians were unblinded. CONCLUSION: Telehealth-delivered exercise and diet programs improved pain and function in people with knee osteoarthritis and overweight or obesity. A dietary intervention conferred modest additional pain and function benefits over exercise. PRIMARY FUNDING SOURCE: Medibank, the Medibank Better Health Foundation Research Fund, and a National Health and Medical Research Council Centre of Research Excellence.

Do Certain Patient Cohorts Benefit From Different Surgical Approaches in Total Hip Arthroplasty?

BACKGROUND: Unfortunately, an important minority of total hip arthroplasty (THA) patients report unsatisfactory outcomes. We aimed to compare the patient-reported outcome measures (PROMs) for three main THA approaches and evaluate the effect of sex and body mass index (BMI) on PROMs over a 10-year period. METHODS: A total of 906 patients (535 women, mean BMI 30.7 [range, 15 to 58]; 371 men, mean BMI 31.2 [range, 17 to 56]) who underwent primary THA by an anterior (AA) (312), lateral (LA) (211), or posterior (383) approach between 2009 and 2020 at a single institution were evaluated using the Oxford Hip Score (OHS). PROMs were prospectively collected before surgery and routinely at 6 weeks, 6 months, and 1, 2, 5, and 10 years after surgery. RESULTS: All three approaches resulted in significant postoperative OHS improvement. Overall, women experienced significantly lower OHS than men (P < .01). A significant negative relationship between BMI and OHS was identified and this relationship was exacerbated with an AA (P < .01). Women who had a BMI ≤ 25 reported OHS with a difference more than 5 points in favor of the AA, while women who had a BMI ≥ 42 reported an OHS with a difference more than 5 in favor of the LA. The BMI ranges were wider when comparing the anterior and posterior approaches, 22 to 46 for women and > 50 for men. For men, an OHS difference more than 5 was only seen with BMI ≥ 45 in favor of the LA. CONCLUSION: This study demonstrated that no single THA approach is superior to another but rather that certain patient cohorts may benefit more from specific approaches. We suggest that women who have a BMI ≤ 25 should consider undergoing an anterior approach for THA, while for women who have a BMI ≥ 42, a lateral approach or for a BMI ≥ 46, a posterior approach is advised.

Effects of adding aerobic physical activity to strengthening exercise on hip osteoarthritis symptoms: protocol for the PHOENIX randomised controlled trial.

BACKGROUND: Hip osteoarthritis (OA) is a leading cause of musculoskeletal pain. Exercise is a core recommended treatment. Most evidence is based on muscle-strengthening exercise, but aerobic physical activity has potential to enhance clinical benefits. The primary aim of this study is to test the hypothesis that adding aerobic physical activity to a muscle strengthening exercise leads to significantly greater reduction in hip pain and improvements in physical function, compared to a lower-limb muscle strengthening exercise program alone at 3 months. METHODS: This is a superiority, 2-group, parallel randomised controlled trial including 196 people with symptomatic hip OA from the community. Following baseline assessment, participants are randomly allocated to receive either i) aerobic physical activity and muscle strengthening exercise or; ii) muscle strengthening exercise only. Participants in both groups receive 9 consultations with a physiotherapist over 3 months. Both groups receive a progressive muscle strengthening exercise program in addition to advice about OA management. The aerobic physical activity plan includes a prescription of moderate intensity aerobic physical activity with a goal of attaining 150 min per week. Primary outcomes are self-reported hip pain assessed on an 11-point numeric rating scale (0 = 'no pain' and 10 = 'worst pain possible') and self-reported physical function (Western Ontario and McMaster Universities Osteoarthritis Index physical function subscale) at 3 months. Secondary outcomes include other measures of self-reported pain (assessed at 0, 3, 9 months), self-reported physical function (assessed at 0, 3, 9 months), performance-based physical function (assessed at 0, 3 months), joint stiffness (assessed at 0, 3, 9 months), quality of life (assessed at 0, 3, 9 months), muscle strength (assessed at 0, 3 months), and cardiorespiratory fitness (assessed at 0, 3 months). Other measures include adverse events, co-interventions, and adherence. Measures of body composition, serum inflammatory biomarkers, quantitative sensory measures, anxiety, depression, fear of movement and self-efficacy are included to explore causal mechanisms. DISCUSSION: Findings will assist to provide an evidence-based recommendation regarding the additional effect of aerobic physical activity to lower-limb muscle strengthening on hip OA pain and physical function. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference: ACTRN 12619001297112. Registered 20th September 2019.

Effects of adding a diet intervention to exercise on hip osteoarthritis pain: protocol for the ECHO randomized controlled trial.

BACKGROUND: Hip osteoarthritis (OA) is a leading cause of musculoskeletal pain. Exercise is a core recommended treatment. Despite some clinical guidelines also recommending weight loss for hip OA, there is no evidence from randomised controlled trials (RCT) to substantiate these recommendations. This superiority, 2-group, parallel RCT will compare a combined diet and exercise program to an exercise only program, over 6 months. METHODS: One hundred people with symptomatic and radiographic hip OA will be recruited from the community. Following baseline assessment, participants will be randomly allocated to either, i) diet and exercise or; ii) exercise only. Participants in the diet and exercise group will have six consultations with a dietitian and five consultations with a physiotherapist via videoconferencing over 6 months. The exercise only group will have five consultations with a physiotherapist via videoconferencing over 6 months. The exercise program for both groups will include prescription of strengthening exercise and a physical activity plan, advice about OA management and additional educational resources. The diet intervention includes prescription of a ketogenic very low-calorie diet with meal replacements and educational resources to support weight loss and healthy eating. Primary outcome is self-reported hip pain via an 11-point numeric rating scale (0 = 'no pain' and 10 = 'worst pain possible') at 6 months. Secondary outcomes include self-reported body weight (at 0, 6 and 12 months) and body mass index (at 0, 6 and 12 months), visceral fat (measured using dual energy x-ray absorptiometry at 0 and 6 months), pain, physical function, quality of life (all measured using subscales of the Hip Osteoarthritis Outcome Scale at 0, 6 and 12 months), and change in pain and physical activity (measured using 7-point global rating of change Likert scale at 6 and 12 months). Additional measures include adherence, adverse events and cost-effectiveness. DISCUSSION: This study will determine whether a diet intervention in addition to exercise provides greater hip pain-relief, compared to exercise alone. Findings will assist clinicians in providing evidence-based advice regarding the effect of a dietary intervention on hip OA pain. TRIAL REGISTRATION: ClinicalTrials.gov . Identifier: NCT04825483 . Registered 31st March 2021.

Can a Hip Brace Improve Short-Term Hip-Related Quality of Life for People With Femoroacetabular Impingement and Acetabular Labral Tears: An Exploratory Randomized Trial.

OBJECTIVES: To examine whether a hip brace can improve hip health quality-of-life (QoL) and is well-tolerated in people with femoroacetabular impingement syndrome (FAIS) or symptomatic labral tears after 6 weeks of wear. DESIGN: Parallel, two-arm, exploratory randomized trial. SETTING: Hospital and private clinics of orthopaedic surgeons. PARTICIPANTS: Individuals >18 years with FAIS or labral tears. INTERVENTIONS: Usual conservative care versus usual conservative care plus a hip brace. MAIN OUTCOMES: Patient-reported outcomes were assessed with the International Hip Outcome Tool (iHOT-33), and Copenhagen Hip and Groin Outcome Scores (HAGOS). Brace acceptability was measured using the Quebec User Evaluation of Satisfaction with Assistive Technology survey. Independent t-tests assessed between-group differences. RESULTS: Thirty-eight participants were recruited, 19 each group, 60% women, mean age 39.3 ± 11.8 years, body mass index 25.3 ± 4.4 kg/m2, iHOT-33 36.6 ± 24.8. Three participants dropped out (one usual care, 2 braced). The mean between-group difference for iHOT-33 was 19.4 (95% confidence interval [CI] 1.68-37.06, P = 0.03) favoring the brace. There were improvements in most HAGOS subscale scores favoring the brace. Issues with brace tolerability for some participants were perceived comfort and effectiveness. Three brace-related adverse events were reported. CONCLUSION: Between-group differences favored the braced group for hip health QoL, pain, symptoms, and function. Although these were promising results, the CIs for the estimates were wide, the small sample size likely a contributing factor. Our results suggest that further investigation of the brace is warranted, we calculated sample sizes and made recommendations for the design of a future trial.

Multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapist-led care for femoroacetabular impingement (FAI) syndrome on hip cartilage metabolism: the Australian FASHIoN trial.

BACKGROUND: Arthroscopic surgery for femoroacetabular impingement syndrome (FAI) is known to lead to self-reported symptom improvement. In the context of surgical interventions with known contextual effects and no true sham comparator trials, it is important to ascertain outcomes that are less susceptible to placebo effects. The primary aim of this trial was to determine if study participants with FAI who have hip arthroscopy demonstrate greater improvements in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to participants who undergo physiotherapist-led management. METHODS: Multi-centre, pragmatic, two-arm superiority randomised controlled trial comparing physiotherapist-led management to hip arthroscopy for FAI. FAI participants were recruited from participating orthopaedic surgeons clinics, and randomly allocated to receive either physiotherapist-led conservative care or surgery. The surgical intervention was arthroscopic FAI surgery. The physiotherapist-led conservative management was an individualised physiotherapy program, named Personalised Hip Therapy (PHT). The primary outcome measure was change in dGEMRIC score between baseline and 12 months. Secondary outcomes included a range of patient-reported outcomes and structural measures relevant to FAI pathoanatomy and hip osteoarthritis development. Interventions were compared by intention-to-treat analysis. RESULTS: Ninety-nine participants were recruited, of mean age 33 years and 58% male. Primary outcome data were available for 53 participants (27 in surgical group, 26 in PHT). The adjusted group difference in change at 12 months in dGEMRIC was -59 ms (95%CI - 137.9 to - 19.6) (p = 0.14) favouring PHT. Hip-related quality of life (iHOT-33) showed improvements in both groups with the adjusted between-group difference at 12 months showing a statistically and clinically important improvement in arthroscopy of 14 units (95% CI 5.6 to 23.9) (p = 0.003). CONCLUSION: The primary outcome of dGEMRIC showed no statistically significant difference between PHT and arthroscopic hip surgery at 12 months of follow-up. Patients treated with surgery reported greater benefits in symptoms at 12 months compared to PHT, but these benefits are not explained by better hip cartilage metabolism. TRIAL REGISTRATION DETAILS: Australia New Zealand Clinical Trials Registry reference: ACTRN12615001177549 . Trial registered 2/11/2015.

Better Knee, Better Me™: effectiveness of two scalable health care interventions supporting self-management for knee osteoarthritis - protocol for a randomized controlled trial.

BACKGROUND: Although education, exercise, and weight loss are recommended for management of knee osteoarthritis, the additional benefits of incorporating weight loss strategies into exercise interventions have not been well investigated. The aim of this study is to compare, in a private health insurance setting, the clinical- and cost-effectiveness of a remotely-delivered, evidence- and theory-informed, behaviour change intervention targeting exercise and self-management (Exercise intervention), with the same intervention plus active weight management (Exercise plus weight management intervention), and with an information-only control group for people with knee osteoarthritis who are overweight or obese. METHODS: Three-arm, pragmatic parallel-design randomised controlled trial involving 415 people aged ≥45 and ≤ 80 years, with body mass index ≥28 kg/m2 and < 41 kg/m2 and painful knee osteoarthritis. Recruitment is Australia-wide amongst Medibank private health insurance members. All three groups receive access to a bespoke website containing information about osteoarthritis and self-management. Participants in the Exercise group also receive six consultations with a physiotherapist via videoconferencing over 6 months, including prescription of a strengthening exercise and physical activity program, advice about management, and additional educational resources. The Exercise plus weight management group receive six consultations with a dietitian via videoconferencing over 6 months, which include a very low calorie ketogenic diet with meal replacements and resources to support behaviour change, in addition to the interventions of the Exercise group. Outcomes are measured at baseline, 6 and 12 months. Primary outcomes are self-reported knee pain and physical function at 6 months. Secondary outcomes include weight, physical activity levels, quality of life, global rating of change, satisfaction with care, knee surgery and/or appointments with an orthopaedic surgeon, and willingness to undergo surgery. Additional measures include adherence, adverse events, self-efficacy, and perceived usefulness of intervention components. Cost-effectiveness of each intervention will also be assessed. DISCUSSION: This pragmatic study will determine whether a scalable remotely-delivered service combining weight management with exercise is more effective than a service with exercise alone, and with both compared to an information-only control group. Findings will inform development and implementation of future remotely-delivered services for people with knee osteoarthritis. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12618000930280 (01/06/2018).

Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial.

BACKGROUND: Femoroacetabular impingement syndrome (FAI), a hip disorder affecting active young adults, is believed to be a leading cause of hip osteoarthritis (OA). Current management approaches for FAI include arthroscopic hip surgery and physiotherapy-led non-surgical care; however, there is a paucity of clinical trial evidence comparing these approaches. In particular, it is unknown whether these management approaches modify the future risk of developing hip OA. The primary objective of this randomised controlled trial is to determine if participants with FAI who undergo hip arthroscopy have greater improvements in hip cartilage health, as demonstrated by changes in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to those who undergo physiotherapy-led non-surgical management. METHODS: This is a pragmatic, multi-centre, two-arm superiority randomised controlled trial comparing hip arthroscopy to physiotherapy-led management for FAI. A total of 140 participants with FAI will be recruited from the clinics of participating orthopaedic surgeons, and randomly allocated to receive either surgery or physiotherapy-led non-surgical care. The surgical intervention involves arthroscopic FAI surgery from one of eight orthopaedic surgeons specialising in this field, located in three different Australian cities. The physiotherapy-led non-surgical management is an individualised physiotherapy program, named Personalised Hip Therapy (PHT), developed by a panel to represent the best non-operative care for FAI. It entails at least six individual physiotherapy sessions over 12 weeks, and up to ten sessions over six months, provided by experienced musculoskeletal physiotherapists trained to deliver the PHT program. The primary outcome measure is the change in dGEMRIC score of a ROI containing both acetabular and femoral head cartilages at the chondrolabral transitional zone of the mid-sagittal plane between baseline and 12 months. Secondary outcomes include patient-reported outcomes and several structural and biomechanical measures relevant to the pathogenesis of FAI and development of hip OA. Interventions will be compared by intention-to-treat analysis. DISCUSSION: The findings will help determine whether hip arthroscopy or an individualised physiotherapy program is superior for the management of FAI, including for the prevention of hip OA. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry reference: ACTRN12615001177549 . Trial registered 2/11/2015 (retrospectively registered).

Efficacy of a physiotherapy rehabilitation program for individuals undergoing arthroscopic management of femoroacetabular impingement - the FAIR trial: a randomised controlled trial protocol.

BACKGROUND: Femoroacetabular impingement is a common cause of hip/groin symptoms and impaired functional performance in younger sporting populations and results from morphological abnormalities of the hip in which the proximal femur abuts against the acetabular rim. Many people with symptomatic femoroacetabular impingement undergo arthroscopic hip surgery to correct the bony abnormalities. While many case series over the past decade have reported favourable surgical outcomes, it is not known whether formal rehabilitation is needed as part of the management of patients undergoing this surgical procedure. This randomised controlled trial will investigate the efficacy of a progressive physiotherapist-supervised rehabilitation program (Takla-O'Donnell Protocol) in improving health-related quality of life, physical function and symptoms in individuals undergoing arthroscopic management of femoroacetabular impingement. METHODS/DESIGN: 100 people aged 16-35 years undergoing hip arthroscopy for symptomatic femoroacetabular impingement will be recruited from surgical practices in Melbourne, Australia and randomly allocated to either a physiotherapy or control group. Both groups will receive written information and one standardised post-operative physiotherapy visit whilst in hospital as per usual care. Those in the physiotherapy group will also receive seven individual 30-minute physiotherapy sessions, including one pre-operative visit (within 2 weeks of surgery) and six post-operative visits at fortnightly intervals (commencing two weeks after surgery). The physiotherapy intervention will incorporate education and advice, manual techniques and prescription of a progressive rehabilitation program including home, aquatic and gym exercises. The control group will not receive additional physiotherapy management. Measurements will be taken at baseline (2 weeks pre-operatively) and at 14 and 24 weeks post-surgery. Primary outcomes are the International Hip Outcome Tool and the sports subscale of the Hip Outcome Score at 14 weeks post-surgery. Secondary outcomes include the Copenhagen Hip and Groin Outcome Score, the activities of daily living subscale of the Hip Outcome Score, the Heidelberg Sports Activity Score, a modified Tegner Activity Scale and participant-perceived overall change. DISCUSSION: The findings from this randomised controlled trial will provide evidence for the efficacy of a specific physiotherapist-supervised rehabilitation program in improving outcomes following arthroscopic management of symptomatic femoroacetabular impingement. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference number: ACTRN12613000282785.

The effect of 3 commonly used surgical approaches for total hip arthroplasty on mid- to long-term patient-reported outcome measures.

INTRODUCTION: The most effective surgical approach for total hip arthroplasty (THA) remains controversial. Comparisons of surgical approach based on patient-reported outcome measures (PROMs) have been limited to short- to mid-term outcomes or the comparison of only 2 approaches. The aim of this study was to compare PROMs for the 3 main approaches for THA with up to 10 years follow-up. METHODS: A total of 906 patients who underwent primary THA at a single hospital between 2009 and 2020 through an anterior (312), lateral (211) or posterior (383) approach were evaluated using the Oxford Hip Score (OHS), EuroQoL-5-Dimension (EQ-5D-5L) and visual analogue scale/verbal rating scale for pain (VAS/VRS). PROMs were prospectively collected before surgery and routinely at 6 weeks, 6 months and 1, 2, 5 and 10 years after surgery. RESULTS: There was no significant difference in demographics or comorbidities between the 3 groups. All 3 approaches resulted in a significant improvement in overall PROMs after THA, and plateaued after 6 months postoperatively, with no difference between the approaches (OHS, p < 0.01;EQ-5D-5L Index, p < 0.01;VAS/VRS, p < 0.01). The EQ-5D-5L mobility dimension showed that the lateral approach resulted in 20% more patients reporting problems with mobility than the posterior and anterior approaches at the 6-week, 6-month, 2-year and 10-year follow-up. CONCLUSIONS: This study shows that all 3 common THA approaches substantially and similarly improve the OHS, EQ-5D-5L Index and VRS between 6 months and 10 years postoperatively. However, patient-reported mobility was poorer after a lateral approach and continued to be so at long-term follow-up.

Squatting biomechanics following physiotherapist-led care or hip arthroscopy for femoroacetabular impingement syndrome: a secondary analysis from a randomised controlled trial.

Background: Femoroacetabular impingement syndrome (FAIS) can cause hip pain and chondrolabral damage that may be managed non-operatively or surgically. Squatting motions require large degrees of hip flexion and underpin many daily and sporting tasks but may cause hip impingement and provoke pain. Differential effects of physiotherapist-led care and arthroscopy on biomechanics during squatting have not been examined previously. This study explored differences in 12-month changes in kinematics and moments during squatting between patients with FAIS treated with a physiotherapist-led intervention (Personalised Hip Therapy, PHT) and arthroscopy. Methods: A subsample (n = 36) of participants with FAIS enrolled in a multi-centre, pragmatic, two-arm superiority randomised controlled trial underwent three-dimensional motion analysis during squatting at baseline and 12-months following random allocation to PHT (n = 17) or arthroscopy (n = 19). Changes in time-series and peak trunk, pelvis, and hip biomechanics, and squat velocity and maximum depth were explored between treatment groups. Results: No significant differences in 12-month changes were detected between PHT and arthroscopy groups. Compared to baseline, the arthroscopy group squatted slower at follow-up (descent: mean difference -0.04 m∙s-1 (95%CI [-0.09 to 0.01]); ascent: -0.05 m∙s-1 [-0.11 to 0.01]%). No differences in squat depth were detected between or within groups. After adjusting for speed, trunk flexion was greater in both treatment groups at follow-up compared to baseline (descent: PHT 7.50° [-14.02 to -0.98]%; ascent: PHT 7.29° [-14.69 to 0.12]%, arthroscopy 16.32° [-32.95 to 0.30]%). Compared to baseline, both treatment groups exhibited reduced anterior pelvic tilt (descent: PHT 8.30° [0.21-16.39]%, arthroscopy -10.95° [-5.54 to 16.34]%; ascent: PHT -7.98° [-0.38 to 16.35]%, arthroscopy -10.82° [3.82-17.81]%), hip flexion (descent: PHT -11.86° [1.67-22.05]%, arthroscopy -16.78° [8.55-22.01]%; ascent: PHT -12.86° [1.30-24.42]%, arthroscopy -16.53° [6.72-26.35]%), and knee flexion (descent: PHT -6.62° [0.56- 12.67]%; ascent: PHT -8.24° [2.38-14.10]%, arthroscopy -8.00° [-0.02 to 16.03]%). Compared to baseline, the PHT group exhibited more plantarflexion during squat ascent at follow-up (-3.58° [-0.12 to 7.29]%). Compared to baseline, both groups exhibited lower external hip flexion moments at follow-up (descent: PHT -0.55 N∙m/BW∙HT[%] [0.05-1.05]%, arthroscopy -0.84 N∙m/BW∙HT[%] [0.06-1.61]%; ascent: PHT -0.464 N∙m/BW∙HT[%] [-0.002 to 0.93]%, arthroscopy -0.90 N∙m/BW∙HT[%] [0.13-1.67]%). Conclusion: Exploratory data suggest at 12-months follow-up, neither PHT or hip arthroscopy are superior at eliciting changes in trunk, pelvis, or lower-limb biomechanics. Both treatments may induce changes in kinematics and moments, however the implications of these changes are unknown. Trial registration details: Australia New Zealand Clinical Trials Registry reference: ACTRN12615001177549. Trial registered 2/11/2015.

Suture-tape augmentation of anterior cruciate ligament reconstruction: a prospective, randomised controlled trial (STACLR).

BACKGROUND: Anterior cruciate ligament (ACL) reconstruction aims to restore anteroposterior and rotatory stability to the knee following ACL injury. This requires the graft to withstand the forces applied during the process of ligamentisation and the rehabilitative period. We hypothesise that the use of suture tape augmentation of single bundle ACL reconstruction (ACLR) will reduce residual knee laxity and improve patient-reported outcomes at 2-year follow-up. We will conduct a 1:1 parallel arm single-centre randomised controlled trial comparing suture tape augmented ACLR to standard ACLR technique. METHODS: The study design will be a parallel arm 1:1 allocation ratio randomised controlled trial. Sixty-six patients aged 18 and over waitlisted for primary ACLR will be randomised. Patients requiring osteotomy and extra-articular tenodesis and who have had previous contralateral ACL rupture or repair of meniscal or cartilage pathology that modifies the post-operative rehabilitation will be excluded. The primary outcome measure will be the side-to-side difference in anterior tibial translation (measured on the GNRB arthrometer) at 24 months post-surgery. GNRB arthrometer measures will also be taken preoperatively, at 3 months and 12 months post-surgery. Secondary outcomes will include patient-reported outcome measures (PROMs) collected online, including quality of life, activity and readiness to return to sport, complication rates (return to theatre, graft failure and rates of sterile effusion), examination findings and return to sport outcomes. Participants will be seen preoperatively, at 6 weeks, 3 months, 12 months and 24 months post-surgery. Participants and those taking arthrometer measures will be blinded to allocation. DISCUSSION: This will be the first randomised trial to investigate the effect of suture-tape augmentation of ACLR on either objective or subjective outcome measures. The use of suture-tape augmentation in ACLR has been associated with promising biomechanical and animal-level studies, exhibiting equivalent complication profiles to the standard technique, with initial non-comparative clinical studies establishing possible areas of advantage for the technique. The successful completion of this trial will allow for an improved understanding of the in situ validity of tape augmentation whilst potentially providing a further platform for surgical stabilisation of the ACL graft. TRIAL REGISTRATION: Australia New Zealand Clinical Trial Registry ACTRN12621001162808. Universal Trial Number (UTN): U1111-1268-1487. Registered prospectively on 27 August 2021.

'I saw it as a marriage-You can't have one without the other': A qualitative study of patient and physiotherapist experiences with a therapeutic combined strength and aerobic physical activity exercise programme for hip osteoarthritis.

INTRODUCTION: To explore physiotherapist and patient experiences with, and acceptability of, a 12-week physiotherapist-guided combined strength and aerobic physical activity exercise programme for hip osteoarthritis (OA). METHODS: A qualitative study using semi-structured interviews with 13 people with hip OA and four physiotherapists. Patients underwent a 12-week home exercise programme customised by weekly visits with one of the four physiotherapists. The programme aimed for patients to participate in 150 min of moderate-intensity aerobic physical activity, and 20-30 min of strengthening exercise 2-3 times per week in concordance with American College of Sports Medicine (ACSM) dosage guidelines. Following the programme, patients and physiotherapists participated in individual semi-structured interviews to explore the acceptability of the exercise programme and barriers and facilitators to participation. Data were audio-recorded, transcribed and analysed using a thematic approach. RESULTS: Five over-arching themes (supporting subthemes) were identified from both patient and physiotherapist interviews: (i) positive outcomes (functional improvements, pain relief, empowerment through experience, commitment to continue); (ii) combined benefits of aerobic and strength exercises (complimentary effects, strengthening exercises key); (iii) valuing support from the physiotherapist (personalised care, skill performance feedback, coach effect, accountability); (iv) motivation and opportunity for exercise (positive symptom loop, integration into daily routine, prior exercise experience, Fitbit motivation); and (v) time-consuming commitment (physiotherapy visit frequency, travel inconvenience, time for exercise). CONCLUSIONS: Experiences of participants in this study indicate that, although time-consuming, a combined aerobic physical activity and strengthening programme prescribed at ACSM dosage guidelines is acceptable and confers positive outcomes in individuals with hip OA.

The Effect of Tibial Tunnel Drilling Technique on Retained Intra-Articular Bone Debris Following Anterior Cruciate Ligament Reconstruction.

Purpose: To assess the effect of tibial tunnel drilling technique (retro-drilled bone socket vs full tibial tunnel) on the presence and grade of postoperative, intra-articular bone debris following primary hamstring anterior cruciate ligament (ACL) reconstruction. Methods: This was a retrospective cohort study of primary hamstring autograft ACL reconstructions performed by 2 surgeons. Two blinded independent reviewers assessed the presence and length of retained intra-articular bone debris on the immediate postoperative lateral radiograph. Debris was graded according to a predefined 5-point ordinal grading system: grade 0 (no debris) to IV (severe debris). Results were analyzed according to the type of tibial tunnel; retro-drilled socket or full tibial tunnel using Kappa statistics and the Mann-Whitney U test. Results: Sixty-five patients undergoing primary hamstring ACL were included (39 tibial socket: 26 full tibial tunnel). Bone debris was observed among the tibial socket technique in 29 of 39 instances (74.3%), compared with 14 of 26 (53.8%) instances for the full tibial tunnel technique (P = .09). Where there was measurable debris present, the tibial socket group had a mean length of bone debris of 13.7 ± 6.2 mm as compared with the full tibial tunnel, 10.0 ± 4.7 mm (P = .165). There were significant differences in bone debris gradings between the 2 treatment groups, with tibial sockets having an overall greater grade (P = .04). Conclusions: A difference in the presence of, or length of, retained bone debris on the postoperative lateral radiograph was not demonstrated between the retro-drilled bone socket and full tibial tunnel techniques. However, when bone debris was present, greater grades of debris were seen in the retro-drilled socket group. Level of Evidence: III, retrospective, comparative study.

Combined femoral and acetabular version and synovitis are associated with dGEMRIC scores in people with femoroacetabular impingement (FAI) syndrome.

This study sought to explore, in people with symptoms, signs and imaging findings of femoroacetabular impingement (FAI syndrome): (1) whether more severe labral damage, synovitis, bone marrow lesions, or subchondral cysts assessed on magnetic resonance imaging (MRI) were associated with poorer cartilage health, and (2) whether abnormal femoral, acetabular, and/or combined femoral and acetabular versions were associated with poorer cartilage health. This cross-sectional study used baseline data from the 50 participants with FAI syndrome in the Australian FASHIoN trial (ACTRN12615001177549) with available dGEMRIC scans. Cartilage health was measured using delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) score sampled at the chondrolabral junction on three midsagittal slices, at one acetabular and one femoral head region of interest on each slice, and MRI features were assessed using the Hip Osteoarthritis MRI Score. Analyses were adjusted for alpha angle and body mass index, which are known to affect dGEMRIC score. Linear regression assessed the relationship with the dGEMRIC score of (i) selected MRI features, and (ii) femoral, acetabular, and combined femoral and acetabular versions. Hips with more severe synovitis had worse dGEMRIC scores (partial η2 = 0.167, p = 0.020), whereas other MRI features were not associated. A lower combined femoral and acetabular version was associated with a better dGEMRIC score (partial η2 = 0.164, p = 0.021), whereas isolated measures of femoral and acetabular version were not associated. In conclusion, worse synovitis was associated with poorer cartilage health, suggesting synovium and cartilage may be linked to the pathogenesis of FAI syndrome. A lower combined femoral and acetabular version appears to be protective of cartilage health at the chondrolabral junction.

Cost-Effectiveness of Telehealth-Delivered Exercise and Dietary Weight Loss Programs for Knee Osteoarthritis Within a Twelve-Month Randomized Trial.

OBJECTIVE: To evaluate the cost-effectiveness of telehealth-delivered exercise and diet-plus-exercise programs within 12 months. METHODS: An economic evaluation within a 12-month, 3-arm, parallel randomized trial of two 6-month telehealth-delivered exercise programs, with and without a dietary component. A total of 415 people with knee osteoarthritis ages 45-80 years and body mass index of 28-40 kg/m2 were assigned to 1 of 2 telehealth-delivered exercise programs, 1 without (n = 172) and 1 with (n = 175) a dietary component (ketogenic very low calorie diet), or to an education control (n = 67), for 6 months, with 6 months follow-up. The primary economic outcomes were quality-adjusted life years (QALYs) and health system costs. Measured costs were the direct intervention (consultations, equipment/resources, and meal replacements) and health care use in 2020 Australian dollars ($AU1.5 = $US1). Secondary analysis included weight loss and work productivity gains. RESULTS: The clinical trial demonstrated greater improvements in pain and function compared to information only for individuals with knee osteoarthritis and overweight/obesity. We can be 88% confident that diet plus exercise is cost effective ($45,500 per QALY), 53% confident that exercise is cost-effective ($67,600 per QALY) compared to the control, and 86% confident that augmenting exercise with the diet program is cost effective ($21,100 per QALY). CONCLUSION: Telehealth-delivered programs targeting exercise with dietary intervention for people with knee osteoarthritis who have overweight/obesity are likely to be cost-effective, particularly if potential long-term gains from weight loss and work productivity are realized.

Moderators, Mediators, and Prognostic Indicators of Treatment With Hip Arthroscopy or Physical Therapy for Femoroacetabular Impingement Syndrome: Secondary Analyses From the Australian FASHIoN Trial.

BACKGROUND: Although randomized controlled trials comparing hip arthroscopy with physical therapy for the treatment of femoroacetabular impingement (FAI) syndrome have emerged, no studies have investigated potential moderators or mediators of change in hip-related quality of life. PURPOSE: To explore potential moderators, mediators, and prognostic indicators of the effect of hip arthroscopy and physical therapy on change in 33-item international Hip Outcome Tool (iHOT-33) score for FAI syndrome. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: Overall, 99 participants were recruited from the clinics of orthopaedic surgeons and randomly allocated to treatment with hip arthroscopy or physical therapy. Change in iHOT-33 score from baseline to 12 months was the dependent outcome for analyses of moderators, mediators, and prognostic indicators. Variables investigated as potential moderators/prognostic indicators were demographic variables, symptom duration, alpha angle, lateral center-edge angle (LCEA), Hip Osteoarthritis MRI Scoring System (HOAMS) for selected magnetic resonance imaging (MRI) features, and delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) score. Potential mediators investigated were change in chosen bony morphology measures, HOAMS, and dGEMRIC score from baseline to 12 months. For hip arthroscopy, intraoperative procedures performed (femoral ostectomy ± acetabular ostectomy ± labral repair ± ligamentum teres debridement) and quality of surgery graded by a blinded surgical review panel were investigated for potential association with iHOT-33 change. For physical therapy, fidelity to the physical therapy program was investigated for potential association with iHOT-33 change. RESULTS: A total of 81 participants were included in the final moderator/prognostic indicator analysis and 85 participants in the final mediator analysis after exclusion of those with missing data. No significant moderators or mediators of change in iHOT-33 score from baseline to 12 months were identified. Patients with smaller baseline LCEA (ß = -0.82; P = .034), access to private health care (ß = 12.91; P = .013), and worse baseline iHOT-33 score (ß = -0.48; P < .001) had greater iHOT-33 improvement from baseline to 12 months, irrespective of treatment allocation, and thus were prognostic indicators of treatment response. Unsatisfactory treatment fidelity was associated with worse treatment response (ß = -24.27; P = .013) for physical therapy. The quality of surgery and procedures performed were not associated with iHOT-33 change for hip arthroscopy (P = .460-.665 and P = .096-.824, respectively). CONCLUSION: No moderators or mediators of change in hip-related quality of life were identified for treatment of FAI syndrome with hip arthroscopy or physical therapy in these exploratory analyses. Patients who accessed the Australian private health care system, had smaller LCEAs, and had worse baseline iHOT-33 scores, experienced greater iHOT-33 improvement, irrespective of treatment allocation.

Which hip morphology measures and patient factors are associated with age of onset and symptom severity in femoroacetabular impingement syndrome?

BACKGROUND: Bony morphology is central to the pathomechanism of femoroacetabular impingement syndrome (FAIS), however isolated radiographic measures poorly predict symptom onset and severity. More comprehensive morphology measurement considered together with patient factors may better predict symptom presentation. This study aimed to determine the morphological parameter(s) and patient factor(s) associated with symptom age of onset and severity in FAIS. METHODS: 99 participants (age 32.9 ± 10.5 years; body mass index (BMI 24.3 ± 3.1 kg/m2; 42% females) diagnosed with FAIS received standardised plain radiographs and magnetic resonance scans. Alpha angle in four radial planes (superior to anterior), acetabular version (AV), femoral torsion, lateral centre-edge, anterior centre-edge (ACEA) and femoral neck-shaft angles were measured. Age of symptom onset (age at presentation minus duration of symptoms), international Hip Outcome Tool-33 (iHOT-33) and modified UCLA activity scores were recorded. Backward stepwise regression assessed morphological parameters and patient factors (age, sex, BMI, symptom duration, annual income, private/public healthcare system accessed) to determine variables independently associated with onset age and iHOT-33 score. RESULTS: Earlier symptom onset was associated with larger superoanterior alpha angle (p = 0.007), smaller AV (p = 0.023), lower BMI (p = 0.010) and public healthcare system access (p = 0.041) (r2 = 0.320). Worse iHOT-33 score was associated with smaller ACEA (p = 0.034), female sex (p = 0.040), worse modified UCLA activity score (p = 0.010) and public healthcare system access (p < 0.001) (r2 = 0.340). CONCLUSIONS: Age of symptom onset was chiefly predicted by femoral and acetabular bony morphology measures, whereas symptom severity predominantly by patient factors. Factors measured explained a small amount of variance in the data; additional unmeasured factors may be more influential.

Automated volumetric and statistical shape assessment of cam-type morphology of the femoral head-neck region from clinical 3D magnetic resonance images.

Background: Femoroacetabular impingement (FAI) cam morphology is routinely assessed using manual measurements of two-dimensional (2D) alpha angles which are prone to high rater variability and do not provide direct three-dimensional (3D) data on these osseous formations. We present CamMorph, a fully automated 3D pipeline for segmentation, statistical shape assessment and measurement of cam volume, surface area and height from clinical magnetic resonance (MR) images of the hip in FAI patients. Methods: The novel CamMorph pipeline involves two components: (I) accurate proximal femur segmentation generated by combining the 3D U-net to identify both global (region) and local (edge) features in clinical MR images and focused shape modelling to generate a 3D anatomical model for creating patient-specific proximal femur models; (II) patient-specific anatomical information from 3D focused shape modelling to simulate 'healthy' femoral bone models with cam-affected region constraints applied to the anterosuperior femoral head-neck region to quantify cam morphology in FAI patients. The CamMorph pipeline, which generates patient-specific data within 5 min, was used to analyse multi-site clinical MR images of the hip to measure and assess cam morphology in male (n=56) and female (n=41) FAI patients. Results: There was excellent agreement between manual and CamMorph segmentations of the proximal femur as demonstrated by the mean Dice similarity index (DSI; 0.964±0.006), 95% Hausdorff distance (HD; 2.123±0.876 mm) and average surface distance (ASD; 0.539±0.189 mm) values. Compared to female FAI patients, male patients had a significantly larger median cam volume (969.22 vs. 272.97 mm3, U=240.0, P<0.001), mean surface area [657.36 vs. 306.93 mm2, t(95)=8.79, P<0.001], median maximum-height (3.66 vs. 2.15 mm, U=407.0, P<0.001) and median average-height (1.70 vs. 0.86 mm, U=380.0, P<0.001). Conclusions: The fully automated 3D CamMorph pipeline developed in the present study successfully segmented and measured cam morphology from clinical MR images of the hip in male and female patients with differing FAI severity and pathoanatomical characteristics.

Automated 3D Analysis of Clinical Magnetic Resonance Images Demonstrates Significant Reductions in Cam Morphology Following Arthroscopic Intervention in Contrast to Physiotherapy.

Purpose: To obtain automated measurements of cam volume, surface area, and height from baseline (preintervention) and 12-month magnetic resonance (MR) images acquired from male and female patients allocated to physiotherapy (PT) or arthroscopic surgery (AS) management for femoroacetabular impingement (FAI) in the Australian FASHIoN trial. Methods: An automated segmentation pipeline (CamMorph) was used to obtain cam morphology data from three-dimensional (3D) MR hip examinations in FAI patients classified with mild, moderate, or major cam volumes. Pairwise comparisons between baseline and 12-month cam volume, surface area, and height data were performed within the PT and AS patient groups using paired t-tests or Wilcoxon signed-rank tests. Results: A total of 43 patients were included with 15 PT patients (9 males, 6 females) and 28 AS patients (18 males, 10 females) for premanagement and postmanagement cam morphology assessments. Within the PT male and female patient groups, there were no significant differences between baseline and 12-month mean cam volume (male: 1269 vs 1288 mm3, t[16] = -0.39; female: 545 vs 550 mm,3 t[10] = -0.78), surface area (male: 1525 vs 1491 mm2, t[16] = 0.92; female: 885 vs 925 mm,2 t[10] = -0.78), maximum height (male: 4.36 vs 4.32 mm, t[16] = 0.34; female: 3.05 vs 2.96 mm, t[10] = 1.05) and average height (male: 2.18 vs 2.18 mm, t[16] = 0.22; female: 1.4 vs 1.43 mm, t[10] = -0.38). In contrast, within the AS male and female patient groups, there were significant differences between baseline and 12-month cam volume (male: 1343 vs 718 mm3, W = 0.0; female: 499 vs 240 mm3, t[18] = 2.89), surface area (male: 1520 vs 1031 mm2, t(34) = 6.48; female: 782 vs 483 mm2, t(18) = 3.02), maximum-height (male: 4.3 vs 3.42 mm, W = 13.5; female: 2.85 vs 2.24 mm, t(18) = 3.04) and average height (male: 2.17 vs 1.52 mm, W = 3.0; female: 1.4 vs 0.94 mm, W = 3.0). In AS patients, 3D bone models provided good visualization of cam bone mass removal postostectomy. Conclusions: Automated measurement of cam morphology from baseline (preintervention) and 12-month MR images demonstrated that the cam volume, surface area, maximum-height, and average height were significantly smaller in AS patients following ostectomy, whereas there were no significant differences in these cam measures in PT patients from the Australian FASHIoN study. Level of Evidence: Level II, cohort study.