Study protocol ROTATE-trial: anterior cruciate ligament rupture, the influence of a treatment algorithm and shared decision making on clinical outcome- a cluster randomized controlled trial.

BACKGROUND: Anterior cruciate ligament (ACL) rupture is a very common knee injury in the sport active population. There is much debate on which treatment (operative or non-operative) is best for the individual patient. In order to give a more personalized recommendation we aim to evaluate the effectiveness and cost-effectiveness of a treatment algorithm for patients with a complete primary ACL rupture. METHODS: The ROTATE-trial is a multicenter, open-labeled cluster randomized controlled trial with superiority design. Randomization will take place on hospital level (n = 10). Patients must meet all the following criteria: aged 18 year or older, with a complete primary ACL rupture (confirmed by MRI and physical examination) and maximum of 6 weeks of non-operative treatment. Exclusion criteria consists of multi ligament trauma indicated for surgical intervention, presence of another disorder that affects the activity level of the lower limb, pregnancy, and insufficient command of the Dutch language. The intervention to be investigated will be an adjusted treatment decision strategy, including an advice from our treatment algorithm. Patient reported outcomes will be conducted at baseline, 3, 6, 12 and 24 months. Physical examination of the knee at baseline, 12 and 24 months. Primary outcome will be function of the knee measured by the International Knee Documentation Committee (IKDC) questionnaire. Secondary outcomes are, among others, the Tegner activity score, the Knee injury and Osteoarthritis Outcome Score (KOOS) and the 9-item Shared Decision Making Questionnaire (SDM-Q-9). Healthcare use, productivity and satisfaction with ((non-)operative) care are also measured by means of questionnaires. In total 230 patients will be included, resulting in 23 patients per hospital. DISCUSSION: The ROTATE study aims to evaluate the effectiveness and cost-effectiveness of a treatment algorithm for patients with a complete primary ACL rupture compared to current used treatment strategy. Using a treatment algorithm might give the much-wanted personalized treatment recommendation. TRIAL REGISTRATION: This study is approved by the Medical Research Ethics Committee of Erasmus Medical Center in Rotterdam and prospectively registered at the Dutch Trial Registry on May 13th, 2020. Registration number: NL8637.

Morphological variants to predict outcome of avascular necrosis in developmental dysplasia of the hip.

AIMS: The most important complication of treatment of developmental dysplasia of the hip (DDH) is avascular necrosis (AVN) of the femoral head, which can result in proximal femoral growth disturbances leading to pain, dysfunction, and eventually to early onset osteoarthritis. In this study, we aimed to identify morphological variants in hip joint development that are predictive of a poor outcome. METHODS: We retrospectively reviewed all patients who developed AVN after DDH treatment, either by closed and/or open reduction, at a single institution between 1984 and 2007 with a minimal follow-up of eight years. Standard pelvis radiographs obtained at ages one, two, three, five, and eight years, and at latest follow-up were retrieved. The Bucholz-Ogden classification was used to determine the type of AVN on all radiographs. Poor outcome was defined by Severin classification grade 3 or above on the latest follow-up radiographs and/or the need for secondary surgery. With statistical shape modelling, we identified the different shape variants of the hip at each age. Logistic regression analysis was used to associate the different modes or shape variants with poor outcome. RESULTS: In all, 135 patients with AVN were identified, with a minimum of eight years of follow-up. Mean age at time of surgery was 7.0 months (SD 0.45), and mean follow-up was 13.3 years (SD 3.7). Overall, 46% had AVN type 1 while 54% type 2 or higher. More than half of the patients (52.6%) had a poor outcome. We found 11 shape variants that were significantly associated with a poor outcome. These shape variants were predominantly linked to AVN type 2 or higher. CONCLUSION: Specific morphological characteristics on pelvis radiographs of AVN hips were predictive for poor outcome, at a very young age. There was an overall stronger association to Bucholz-Ogden types 2-3-4 with the exception of two modes at age two and five years, linked to AVN type 1. Cite this article: Bone Joint J 2021;103-B(5):999-1004.

Early surgical reconstruction versus rehabilitation with elective delayed reconstruction for patients with anterior cruciate ligament rupture: COMPARE randomised controlled trial.

OBJECTIVE: To assess whether a clinically relevant difference exists in patients' perceptions of symptoms, knee function, and ability to participate in sports over a period of two years after rupture of the anterior cruciate ligament (ACL) between two commonly used treatment regimens. DESIGN: Open labelled, multicentre, parallel randomised controlled trial (COMPARE). SETTING: Six hospitals in the Netherlands, between May 2011 and April 2016. PARTICIPANTS: Patients aged 18 to 65 with an acute rupture of the ACL, recruited from six hospitals. Patients were evaluated at three, six, nine, 12, and 24 months. INTERVENTIONS: 85 patients were randomised to early ACL reconstruction and 82 to rehabilitation followed by optional delayed ACL reconstruction after a three month period (primary non-operative treatment). MAIN OUTCOMES: Patients' perceptions of symptoms, knee function, and ability to participate in sporting activities were assessed with the International Knee Documentation Committee score (optimum score 100) at each time point over 24 months. RESULTS: Between May 2011 and April 2016, 167 patients were enrolled in the study and randomised to one of two treatments (mean age 31.3; 67 (40.%) women), and 163 (98%) completed the trial. In the rehabilitation and optional delayed ACL reconstruction group, 41 (50%) patients underwent reconstruction during follow-up. After 24 months, the early ACL reconstruction group had a significantly better (P=0.026) but not clinically relevant International Knee Documentation Committee score (84.7 v 79.4 (difference between groups 5.3, 95% confidence interval 0.6 to 9.9). After three months of follow-up, the International Knee Documentation Committee score was significantly better (P=0.002) for the rehabilitation and optional delayed ACL reconstruction group (difference between groups -9.3, -14.6 to -4.0). After nine months of follow-up, the difference in the International Knee Documentation Committee score changed in favour of the early ACL reconstruction group. After 12 months, differences between the groups were smaller. In the early ACL reconstruction group, four re-ruptures and three ruptures of the contralateral ACL occurred during follow-up versus two re-ruptures and one rupture of the contralateral ACL in the rehabilitation and optional delayed ACL reconstruction group. CONCLUSIONS: In patients with acute rupture of the ACL, those who underwent early surgical reconstruction, compared with rehabilitation followed by elective surgical reconstruction, had improved perceptions of symptoms, knee function, and ability to participate in sports at the two year follow-up. This finding was significant (P=0.026) but the clinical importance is unclear. Interpretation of the results of the study should consider that 50% of the patients randomised to the rehabilitation group did not need surgical reconstruction. TRIAL REGISTRATION: Netherlands Trial Register NL 2618.

Effectiveness of progressive tendon-loading exercise therapy in patients with patellar tendinopathy: a randomised clinical trial.

OBJECTIVE: To compare the effectiveness of progressive tendon-loading exercises (PTLE) with eccentric exercise therapy (EET) in patients with patellar tendinopathy (PT). METHODS: In a stratified, investigator-blinded, block-randomised trial, 76 patients with clinically diagnosed and ultrasound-confirmed PT were randomly assigned in a 1:1 ratio to receive either PTLE or EET. The primary end point was clinical outcome after 24 weeks following an intention-to-treat analysis, as assessed with the validated Victorian Institute of Sports Assessment for patellar tendons (VISA-P) questionnaire measuring pain, function and ability to play sports. Secondary outcomes included the return to sports rate, subjective patient satisfaction and exercise adherence. RESULTS: Patients were randomised between January 2017 and July 2019. The intention-to-treat population (mean age, 24 years, SD 4); 58 (76%) male) consisted of patients with mostly chronic PT (median symptom duration 2 years). Most patients (82%) underwent prior treatment for PT but failed to recover fully. 38 patients were randomised to the PTLE group and 38 patients to the EET group. The improvement in VISA-P score was significantly better for PTLE than for EET after 24 weeks (28 vs 18 points, adjusted mean between-group difference, 9 (95% CI 1 to 16); p=0.023). There was a trend towards a higher return to sports rate in the PTLE group (43% vs 27%, p=0.13). No significant between-group difference was found for subjective patient satisfaction (81% vs 83%, p=0.54) and exercise adherence between the PTLE group and EET group after 24 weeks (40% vs 49%, p=0.33). CONCLUSIONS: In patients with PT, PTLE resulted in a significantly better clinical outcome after 24 weeks than EET. PTLE are superior to EET and are therefore recommended as initial conservative treatment for PT.

Two-year follow-up of bone mineral density changes in the knee after meniscal allograft transplantation: Results of an explorative study.

BACKGROUND: The potential chondroprotective effect of meniscal allograft transplantation (MAT) is unclear. Subchondral bone mineral density (BMD) and subchondral bone remodeling play important roles in osteoarthritis development. Evaluation of subchondral BMD after MAT might give more insight into the potential chondroprotective effect. The purpose of this study was to determine early BMD changes in the knee after MAT. METHODS: Twenty-six consecutive patients underwent MAT during 2010-2013. The BMD was measured using dual-energy x-ray absorptiometry (DXA) scan preoperatively, and six months, one and two years postoperatively. Bone mineral density was measured in six regions of interest (ROIs) in the tibia and femur (medial, central, lateral) in both treated and healthy contralateral knees. RESULTS: The BMD levels of MAT knees did not significantly change during two years of follow-up in almost all ROIs. Bone mineral density was significant higher in nearly all ROIs in MAT knees at almost all follow-ups compared to healthy contralateral knees. In the healthy contralateral knees, BMD slightly, but not statistically, decreased in the first postoperative year, where it normalized to baseline values at two-year follow-up. The BMD levels in all ROIs did not significantly differ between the patients with or without chondropathy at baseline and two-year follow-up. CONCLUSION: Based on the findings, MAT did not show a significant influence on BMD in the first two postoperative years. Longer follow-up is necessary to prove the potential chondroprotective effect of MAT using BMD measurements.