Measuring Physical Functioning Using Wearable Sensors in Parkinson Disease and Chronic Obstructive Pulmonary Disease (the Accuracy of Digital Assessment of Performance Trial Study): Protocol for a Prospective Observational Study.

BACKGROUND: Physical capacity and physical activity are important aspects of physical functioning and quality of life in people with a chronic disease such as Parkinson disease (PD) or chronic obstructive pulmonary disease (COPD). Both physical capacity and physical activity are currently measured in the clinic using standardized questionnaires and tests, such as the 6-minute walk test (6MWT) and the Timed Up and Go test (TUG). However, relying only on in-clinic tests is suboptimal since they offer limited information on how a person functions in daily life and how functioning fluctuates throughout the day. Wearable sensor technology may offer a solution that enables us to better understand true physical functioning in daily life. OBJECTIVE: We aim to study whether device-assisted versions of 6MWT and TUG, such that the tests can be performed independently at home using a smartwatch, is a valid and reliable way to measure the performance compared to a supervised, in-clinic test. METHODS: This is a decentralized, prospective, observational study including 100 people with PD and 100 with COPD. The inclusion criteria are broad: age ≥18 years, able to walk independently, and no co-occurrence of PD and COPD. Participants are followed for 15 weeks with 4 in-clinic visits, once every 5 weeks. Outcomes include several walking tests, cognitive tests, and disease-specific questionnaires accompanied by data collection using wearable devices (the Verily Study Watch and Modus StepWatch). Additionally, during the last 10 weeks of this study, participants will follow an aerobic exercise training program aiming to increase physical capacity, creating the opportunity to study the responsiveness of the remote 6MWT. RESULTS: In total, 89 people with PD and 65 people with COPD were included in this study. Data analysis will start in April 2024. CONCLUSIONS: The results of this study will provide information on the measurement properties of the device-assisted 6MWT and TUG in the clinic and at home. When reliable and valid, this can contribute to a better understanding of a person's physical capacity in real life, which makes it possible to personalize treatment options. TRIAL REGISTRATION: ClinicalTrials.gov NCT05756075; https://clinicaltrials.gov/study/NCT05756075. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55452.

Asymmetrical trunk movement during walking improved to normal range at 3 months after corrective posterior spinal fusion in adolescent idiopathic scoliosis.

PURPOSE: To investigate the effects of posterior spinal fusion (PSF) and curve type on upper body movements in Adolescent Idiopathic Scoliosis (AIS) patients during gait. METHODS: Twenty-four girls (12-18 years) with AIS underwent PSF. 3D-Gait-analyses were performed preoperatively, at 3 months and 1 year postoperatively. Mean position (0° represents symmetry) and range of motion (ROM) of the trunk (thorax-relative-to-pelvis) in all planes were assessed. Lower body kinematics and spatiotemporal parameters were also evaluated. RESULTS: Mean trunk position improved from 7.0° to 2.9° in transversal plane and from 5.0° to - 0.8° in frontal plane at 3 months postoperative (p < 0.001), and was maintained at 1 year. Trunk ROM in transverse plane decreased from 9.6° to 7.5° (p < 0.001) after surgery. No effects of PSF were observed on the lower body kinematics during the gait cycle. Patients with a double curve had a more axial rotated trunk before and after surgery (p = 0.013). CONCLUSION: In AIS patients, during gait an evident asymmetrical position of the trunk improved to an almost symmetric situation already 3 months after PSF and was maintained at 1 year. Despite a reduction of trunk ROM, patients were able to maintain the same walking pattern in the lower extremities after surgery. This improvement of symmetry and maintenance of normal gait can explain the rapid recovery and well functioning in daily life of AIS patients, despite undergoing a fusion of large parts of their spine.

Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial.

PURPOSE: The primary aim of the study was to examine stability and alignment after total knee arthroplasty (TKA) using patient-specific instrumentation (PSI) and conventional instrumentation (CI). The hypothesis was that stability and alignment would be better using PSI than CI, 12 months postoperatively. The secondary aim included the evaluation of clinical outcomes after TKA. METHODS: In this prospective randomized controlled trial, 42 patients with knee osteoarthritis received a Genesis II PS prosthesis with either PSI or CI. Patients visited the hospital preoperatively and postoperatively after 6 weeks and 3 and 12 months. To evaluate stability, varus-valgus laxity was determined in extension and flexion using stress radiographs 12 months postoperatively. Three months postoperatively, a long-leg radiograph and CT scan were obtained to measure hip-knee-ankle (HKA) alignment and component rotation. Furthermore, frontal and sagittal alignment of the components, the Knee Society Score, VAS Pain, VAS Satisfaction, Knee injury and Osteoarthritis Outcome score, Patella score (Kujala), University of California Los Angeles activity score, anterior-posterior laxity, (serious) adverse device-related events, and intraoperative complications were reported. The clinical outcomes were compared using independent t tests or non-parametric alternatives, and repeated measurements ANOVA with a significance level of p < 0.05. RESULTS: No significant differences were found between the two groups regarding stability, HKA angle, and rotational alignment. In four patients, the PSI did not fit correctly on the tibia and/or femur requiring intraoperative modifications. Both groups improved significantly over time on all clinical outcomes, with no significant differences between the groups 12 months postoperatively. The PSI group showed less tibial slope than the patients in the CI group [PSI 2.6° versus CI 4.8° (p = 0.02)]. Finally, the PSI group more frequently received a thinner insert size than the CI group (p = 0.03). CONCLUSIONS: Patients operated with PSI did not differ from CI in terms of stability and alignment. However, in the PSI group ligament releases were more often required intraoperatively. Furthermore, the two methods did not show different clinical results. It seems that the preoperative planning for the PSI facilitates more conservative bone cuts than CI, but whether this is clinically relevant should be investigated. Since PSI is more expensive and time consuming than CI, and does not outperform CI with regard to clinical results, we recommend to use CI. LEVEL OF EVIDENCE: I.

PEEK Cages in Lumbar Fusion: Mid-term Clinical Outcome and Radiologic Fusion.

STUDY DESIGN: Historical cohort analysis. OBJECTIVE: Evaluation of mid-term clinical outcome and radiologic fusion in patients treated with a polyetheretherketone (PEEK) cage. SUMMARY OF BACKGROUND DATA: Anterior lumbar interbody fusion can be a good alternative in chronic low back pain when conservative treatment fails. Although titanium alloy cages give good fusion rates, disadvantages are the subsidence of the cage in the adjacent vertebrae and problematic radiologic evaluation of fusion. PEEK cages such as the Synfix-LR cage (Synthes, Switzerland) should overcome this. METHODS: From December 2004 until August 2007, 95 patients (21 double-level and 74 single-level) with degenerative disk disease from L3-S1 were operated by a single surgeon. The number of reoperations was counted. Radiologic fusion on computed tomography scan was scored with a new scoring system by an independent skeletal radiologist and orthopedic surgeon. Intraobserver agreement and specificity were assessed. Clinical improvement was measured by the Oswestry Disability Index score. The median duration of clinical follow-up was 47.7 months (range 29.9-61.6). RESULTS: In total, 26 patients were reoperated after a median period of 17.6 months (range 6.7-46.9) of the initial surgery. Of the 26 patients, 23 patients (18 single-level and 5 double-level) were reoperated for symptomatic pseudarthrosis. A moderate agreement (κ=0.36) and a specificity of 70% and 37% for the radiologist and orthopedic surgeon, respectively, were found for scoring bony bridging. The Oswestry Disability Index score improved after initial surgery; however, reoperated patients reported a significantly lower improvement. CONCLUSIONS: A high number of reoperations after an anterior lumbar interbody fusion procedure with the Synfix-LR cage were found, mainly because of symptomatic pseudarthrosis. The absence of posterior fixation in combination with lower stiffness and the hydrophobic characteristics of PEEK probably lead to insufficient initial stability, creating suboptimal conditions for bony bridging, and thus solid fusion. The proposed ease of the evaluation of radiologic fusion could not be supported. Clinicians should be alert on pseudarthrosis when patients treated with the Synfix-LR cage presented with persisted or aggravated complaints.

Poor Radiological and Good Functional Long-term Outcome of Surgically Treated Scheuermann Patients.

STUDY DESIGN: Cohort study. OBJECTIVE: To analyze long-term clinical and radiological outcomes of surgically treated Scheuermann patients. SUMMARY OF BACKGROUND DATA: Long-term clinical and radiological outcomes of surgery for Scheuermann kyphosis are unknown. A single-center cohort of 33 consecutive, surgically treated (between 1991 and 1998) Scheuermann patients was studied. METHODS: Clinical and radiological data of 29 surgically treated Scheuermann patients were collected (posterior approach n = 13; combined anterior-posterior procedure n = 16), after a mean follow-up of 18 years. Oswestry Disability Index (ODI) scores were measured preoperatively (PRE) and twice postoperatively: 2 to 8 years postoperative (FU 1) and 14 to 21 years postoperative (FU 2). Visual Analog Score pain, Short Form-36 (SF-36), and EQ-5d scores were recorded at FU 2 only. Radiographs were analyzed for correction, distal and proximal junctional kyphosis, and implant failures. RESULTS: Mean preoperative kyphosis of the corrected levels was 76° (range 60°-105°) and decreased to a Cobb of 58°(range 30°-105°) at FU 2. Median Visual Analog Score was 2.5 points (range 0-8) and median ODI score was 12 (range 0-62) at FU 2. The ODI score at FU 1 was significantly better as compared to PRE (P < 0.001) and FU 2 (P < 0.001). Also, anterior-posterior treated group had a significantly better ODI score as compared to the posterior-only group (P = 0.023). EQ-5d scores on mobility, usual activities, and pain/discomfort were worse compared to an age-matched population control group; however, SF-36 outcome scores were comparable.Proximal junctional kyphosis was present in 53% of patients, distal junctional kyphosis did not occur, and implant failure/removal had occurred in 69% of patients. Radiological complications do not relate with the ODI, EQ-5d, and SF-36 and 72% of the patients were satisfied. CONCLUSION: Radiological results of this cohort were disappointing but did not relate to clinical outcome scores. Even lumbar pain could not prevent a high patient satisfaction and quality of life. Patients treated with a combined anterior-posterior approach tended to perform better. LEVEL OF EVIDENCE: 3.

Effective nonoperative treatment in juvenile idiopathic scoliosis.

Nonoperative management of juvenile idiopathic scoliosis (JIS) has been reported to be less effective than that of infantile idiopathic scoliosis. The goal of this study was to analyse the results of casting and/or bracing in JIS. Clinical data from seven patients with JIS, treated with casting followed by bracing (n=3) or by bracing alone (n=4), were retrospectively collected, and curve severity was measured before, during and after treatment. The median Cobb angle decreased from 37° to 25°. No patient needed surgery at a median follow-up of 4.6 years (3.4-9.1 years). Casting and/or bracing is effective for the management of JIS.

Reliability and validity of the adapted Dutch version of the revised Scoliosis Research Society 22-item questionnaire.

BACKGROUND CONTEXT: As in other fields of medicine, there is an increasing interest among orthopedic surgeons to measure health-related quality of life in adolescent idiopathic scoliosis patients and to evaluate the burden of disease and the effectiveness of different treatment strategies. The development of the revised Scoliosis Research Society 22-item patient questionnaire (SRS-22r) enabled a comprehensive evaluation of health-related quality of life of these patients. Over the years, the SRS-22r gained wide acceptance and has been used in several different countries, languages, and cultures. The SRS-22r has not been translated into Dutch to date. PURPOSE: To translate the SRS-22r into Dutch and adapt it cross-culturally as outlined by international guidelines and to test its psychometric properties to measure health-related quality of life of adolescent idiopathic scoliosis patients in the Netherlands. STUDY DESIGN/SETTING: A cross-sectional, multicenter validation study. PATIENT SAMPLE: A total of 135 adolescent idiopathic scoliosis patients (mean age 15.1 years old) of three major scoliosis centers in the Netherlands were enrolled in this study. Ninety-two (68%) subjects completed the Dutch SRS-22r, Child Health Questionnaire (CHQ)-CF87 (golden standard for adolescents), and Short Form (SF)-36 (golden standard for adults). Two weeks later, 73 (79%) of 92 respondents returned a second SRS-22r. Demographics, curve type, Risser stage, and treatment status were documented. OUTCOME MEASURES: Floor and ceiling effects, internal consistency, reproducibility, concurrent validity, and discriminative ability of the Dutch version of the SRS-22r questionnaire. METHODS: For content analysis, SRS-22r domain scores (function, pain, self-image, mental health, and satisfaction with management) were explored and floor and ceiling effects were determined. Cronbach's α was calculated for internal consistency of each domain of the questionnaires and reproducibility was assessed by test-retest reliability analysis. Using Pearson's correlation coefficient, comparison of the domains of the Dutch SRS-22r with the domains of the SF-36 and Child Health Questionnaire-CF87 assessed the concurrent validity. Differences in SRS-22r domain scores between untreated patients with different curve severity determined the discriminative ability of the questionnaire. RESULTS: The SRS-22r domains as well as the SF-36 and CHQ-CF87 domains demonstrated no floor effects, but the function, pain, and satisfaction with management domains had ceiling effects, indicating the proportion of subjects with the maximum score between 19.6% and 33.0%. Internal consistency was very satisfactory for all SRS-22r domains: Cronbach's α was between 0.718 and 0.852. By omitting question 15, the internal consistency of the function domain increased from 0.746 to 0.827. Test-retest reliability was ≥0.799 for all SRS-22r domains. The function, pain, mental health, and self-image domains correlated under the 0.001 significance level with the corresponding CHQ-CF87 and SF-36 domains. The satisfaction with management domain did not correlate with the other questionnaires. The SRS-22r had the ability to detect differences between groups with different curve severity; patients with a severe scoliotic curvature had significantly lower pain and self-image domain scores than patients with relatively mild scoliosis. CONCLUSIONS: The Dutch SRS-22r had the properties needed for the measurement of patient perceived health-related quality of life of adolescent idiopathic scoliosis patients in the Netherlands. The Dutch SRS-22r could be used for the longitudinal follow-up of adolescent idiopathic scoliosis patients from adolescence to adulthood and for establishing the effects of conservative or invasive surgical treatment.

Comparison of the short-term results of the first and last 50 Scandinavian total ankle replacements: assessment of the learning curve in a consecutive series.

BACKGROUND: Total ankle replacement (TAR) is presently considered to be an acceptable alternative to ankle fusion for patients with debilitating conditions of the ankle. The placing of a total ankle prosthesis is a technically demanding procedure. We hypothesized that the challenging conditions could cause a longer learning curve (>30 cases), and therefore the short-term results of the first and the last 50 cases in a consecutive series of 134 cases were compared. METHODS: The first and last consecutive 50 cases by a single surgeon in a series of 134 Scandinavian Total Ankle Replacements (STAR; Waldemar Link, Hamburg, Germany), inserted between May 1999 and May 2008, were evaluated. Operation characteristics, clinical outcome (Foot Function Index [FFI], Kofoed score), complications, and the component alignment on X-rays were assessed. The outcome measures for both groups were compared using independent Student t tests, chi-square tests, and nonparametric alternatives (P < .05). RESULTS: Surgery time decreased from a median of 125 (83-160) to 100 (65-170) minutes (P < .001), and fewer perioperative complications were observed (12 vs 4, P = .04). The sagittal alignment of the tibial component was closer to normal in the last series (P < .001). The clinical outcome did not differ between the 2 series (median FFI: 32 [0-74] vs 25 [0-75], Kofoed score: median 71 [21-96] vs 80.5 [23-100]). The major underlying pathology did change from rheumatoid arthritis (60%) to osteoarthritis (44%; P = .002). No differences in type and number of complications were reported. CONCLUSION: The surgery time did decrease, there were fewer perioperative fractures, and the tibial component orientation improved, suggesting the presence of a learning curve. Operative experience and a shift in major underlying pathology did not influence clinical outcome. In view of this learning curve we suggest more restrictive patient selection for at least the first 50 TARs. LEVEL OF EVIDENCE: Level III, comparative series.

Medial patellofemoral ligament reconstruction for patellar maltracking following total knee arthroplasty is effective.

PURPOSE: Maltracking of the patella after total knee arthroplasty (TKA) remains a well-recognized problem. The medial patellofemoral ligament (MPFL) has shown to be important for patellar stabilization and reconstructions of the MPFL have already shown excellent functional outcomes for patellar instability of the native knee. Nevertheless, there is only limited literature on using an MPFL reconstruction for correction of patellar maltracking after TKA. In this retrospective study, a consecutive case series was evaluated. METHODS: Between 2007 and 2010, nine patients (nine knees) with anterior knee pain and symptomatic (sub)luxations of the patella after primary or revision TKA were treated by reconstruction of the MPFL in combination with a lateral release. In two cases, an additional tibial tuberosity transfer was performed, due to insufficient per-operative correction. Pre-operative work-up included a CT scan to rule out component malrotation and disorders in limb alignment. Pre- and post-operative patellar displacement and lateral patellar tilt were measured on axial radiographs. Clinical outcome was evaluated using the visual analogue scale (VAS) satisfaction, VAS pain, dislocation rate and Bartlett patella score. RESULTS: Median patellar displacement improved from 29 mm (0-44) to 0 mm (0-9) post-operatively. Median lateral patellar tilt was 45° (23-62) pre-operative and changed to a median 15° (-3 to 21) post-operative. Median VAS satisfaction was 8 (5-9) and only one patient reported a subluxing feeling afterwards. The Bartlett patella score displayed a diverse picture. CONCLUSIONS: Patellar maltracking after primary or revision TKA without malrotation can effectively be treated by MPFL reconstruction in combination with a lateral release. Only in limited cases, an additional tibial tuberosity transfer is needed. LEVEL OF EVIDENCE: IV.

Reason for revision TKA predicts clinical outcome: prospective evaluation of 150 consecutive patients with 2-years followup.

BACKGROUND: There is limited knowledge regarding the relationship between the reason for revising a TKA and the clinical outcome in terms of satisfaction, pain, and function with time. QUESTIONS/PURPOSES: In a cohort of patients receiving a fully revised TKA, we hypothesized (1) outcomes would differ according to reason for revision at 2 years, (2) outcomes would improve gradually during those 2 years, (3) rates of complications differ depending on the reason for revision, and (4) patients with complications have lower scores. METHODS: We studied a prospective cohort of 150 patients receiving a fully revised TKA using a single implant system in two high-volume centers at 24 months of followup. VAS satisfaction, VAS pain, The Knee Society Scoring System(©) (KSS) clinical and functional scores, and complication rate were correlated with their reasons for revision, including septic loosening, aseptic loosening, component malposition, instability, and stiffness. RESULTS: The aseptic loosening group showed better outcomes compared with the instability, malposition, and septic loosening groups, which showed intermediate results (p < 0.05). The stiffness group performed significantly worse on all outcome measures. The outcome for patients with a complication, after treatment of the complication, was less favorable. CONCLUSIONS: The reason for revision TKA predicts clinical outcomes. Satisfaction, pain reduction, and functional improvement are better and complication rates are lower after revision TKA for aseptic loosening than for other causes of failure. For component malposition, instability, and septic loosening groups, there may be more pain and a higher complication rate. For stiffness, the outcomes are less favorable in all scores. LEVEL OF EVIDENCE: Level III, prognostic study. See Guidelines for Authors for a complete description of levels of evidence.

No effect of traction in patients with low back pain: a single centre, single blind, randomized controlled trial of Intervertebral Differential Dynamics Therapy.

Low back pain (LBP) poses a significant problem to society. Although initial conservative therapy may be beneficial, persisting chronic LBP still frequently leads to expensive invasive intervention. A novel non-invasive therapy that focuses on discogenic LBP is Intervertebral Differential Dynamics Therapy (IDD Therapy, North American Medical Corp. Reg U.S.). IDD Therapy consists of intermittent traction sessions in the Accu-SPINA device (Steadfast Corporation Ltd, Essex, UK), an FDA approved, class II medical device. The intervertebral disc and facet joints are unloaded through axial distraction, positioning and relaxation cycles. The purpose of this study is to investigate the effect of IDD Therapy when added to a standard graded activity program for chronic LBP patients. In a single blind, single centre, randomized controlled trial; 60 consecutive patients were assigned to either the SHAM or the IDD Therapy. All subjects received the standard conservative therapeutic care (graded activity) and 20 sessions in the Accu-SPINA device. The traction weight in the IDD Therapy was systematically increased until 50% of a person's body weight plus 4.45 kg (10 lb) was reached. The SHAM group received a non-therapeutic traction weight of 4.45 kg in all sessions. The main outcome was assessed using a 100-mm visual analogue scale (VAS) for LBP. Secondary outcomes were VAS scores for leg pain, Oswestry Disability Index (ODI), Short-Form 36 (SF-36). All parameters were measured before and 2, 6 and 14 weeks after start of the treatment. Fear of (re)injury due to movement or activities (Tampa Scale for Kinesiophobia), coping strategies (Utrecht Coping List) and use of pain medication were recorded before and at 14 weeks. A repeated measures analysis was performed. The two groups were comparable at baseline in terms of demographic, clinical and psychological characteristics, indicating that the random allocation had succeeded. VAS low back pain improved significantly from 61 (+/-25) to 32 (+/-27) with the IDD protocol and 53 (+/-26) to 36 (+/-27) in the SHAM protocol. Moreover, leg pain, ODI and SF-36 scores improved significantly but in both groups. The use of pain medication decreased significantly, whereas scores for kinesiophobia and coping remained at the same non-pathological level. None of the parameters showed a difference between both protocols. Both treatment regimes had a significant beneficial effect on LBP, leg pain, functional status and quality of life after 14 weeks. The added axial, intermittent, mechanical traction of IDD Therapy to a standard graded activity program has been shown not to be effective.