Electrothermal arthroscopic capsulorrhaphy (ETAC) was a technology introduced for orthopaedic surgery without good scientific clinical evidence supporting its use. This multicentre randomized clinical trial provides the scientific clinical evidence comparing ETAC to Open Inferior Capsular Shift (ICS), by measuring disease-specific quality of life at 2-years post-operatively, in patients with shoulder instability due to capsular redundancy. Fifty-four subjects (37 females and 17 males; mean age 23.3 years (SD = 6.9; 15–44 years) with multidirectional instability (MDI) or multidirectional laxity with antero-inferior instability (MDL-AII) were randomized intra-operatively to ETAC (n = 28) or Open ICS (n = 26) using concealed envelopes, computer-generated, variable block randomization with stratification by surgeon and type of instability. Outcomes were measured at baseline, 3 and 6 months, 1 and 2 years. The Western Ontario Shoulder Instability (WOSI) Index is a quality of life outcome measure that is scored on a visual analog scale from 0 to 100, where a higher score represents better quality of life. Two functional assessments included the American Shoulder and Elbow Society (ASES) Score and the Constant Score. Post-operative recurrent instability and surgical time were also measured. Analyses included ANOVA of repeated measures with Bonferroni adjustments for multiple comparisons, Chi-square and independent t-tests (p < 0.05).Purpose
Method
Summary Results of this two-group parallel design randomised controlled trial indicated one and two year outcomes following ACL reconstruction were not different in one hundred and fifty patients using either an ACL functional knee brace or neoprene knee sleeve. Introduction: The primary objective of this study was to compare postoperative outcomes in patients using an ACL functional knee brace and patients using a neoprene knee sleeve One hundred and fifty patients were randomised to receive an ACL functional knee brace (n=76) or a neoprene sleeve (n=74) at their six week postoperative visit following primary ACL reconstruction. Patients were instructed to wear the knee orthosis during participation in all physical activities. Patients were assessed preoperatively, six weeks, six, twelve, eighteen and twenty-four months postoperatively. Outcome measures included disease-specific quality of life (ACL QOL), KT 1000 and single limb forward hop test administered by a blinded research assistant. One and two-year outcomes were compared after adjusting for baseline scores. A priori directional subgroup hypotheses based on time from injury to surgery, pre-operative KT 1000 scores, and one and two-year compliance scores were evaluated using tests for interactions. Analysis was completed on an intention-to-treat basis. There were no significant between-group differences for any of the outcomes at one and two-year follow-ups. Mean between-group differences at two years were: 2.87% (95% CI: −3.85 – 9.60) for the ACL QOL, 0.07mm (95% CI: −0.80 – 0.93) for KT 1000 side-to-side difference, and 2.64% (95% CI: −4.57 – 9.85) for hop limb symmetry index. There were no significant subgroup findings and adverse events were similar between groups. Confidence intervals for between-group differences are narrow and exclude clinically important differences. These findings suggest a functional knee brace does not result in superior outcomes over a neoprene sleeve following ACL reconstruction.
Patients with moderate to severe osteoarthritis of the knee, on a waiting list for total knearthroplasty, were recruited to a double-blind, randomized clinical trial evaluating neoprene knee braces containing high-power static magnets or sham magnets. Patients wore the brace for a minimum of six hours per day and were evaluated at baseline, two, six, twelve and twenty-four weeks. The subjective outcomes (MACTAR, WOMAC, KOOS, SF-36) and functional outcomes (six minute walk, thirty second stair climb) showed no statistically significant differences between the groups at any of the follow-up time periods. The purpose of this study was to compare the effectiveness of neoprene knee braces containing high-power static magnets to sham magnets in the management of osteoarthritis of the knee No statistically significant difference in patient-related quality-of-life and objective functional evaluation was found between groups. This study provides patients and doctors with evidence as to the efficacy of this type of therapy. It will allow those individuals on fixed incomes to utilize their resources to the best advantage to minimize their symptoms related to osteoarthritis of the knee. A prospective double-blinded randomized clinical trial was conducted. Ninety-five patients with moderate to severe osteoarthritis of the knee were randomized to receive a Magnet (M) or Sham (S) knee brace. Both groups were equal with regards to age (M = 71.1 yrs, S = 66.8yrs), severity of disease, gender and all baseline measures. No statistically significant difference in patient-related quality-of-life and objective functional evaluation was found between groups at any time interval. All study patients were recruited from a knee arthroplasty waiting list. At baseline and at two, six, twelve and twenty-four weeks each patient completed a WOMAC, MACTAR, KOOS quality-of-life questionnaire, SF–36 global health measure, and six minute walk and thirty second stair climb after which they were asked to determine their general fatigue, pain and shortness of breath on a 100mm VAS scale. Patients were instructed to wear their brace at least six hours per day and when active (walking, shopping, golfing).
A reliable and valid measurement tool, The Western Ontario Meniscal Evaluation Tool (WOMET) was developed to assess the benefit of conservative and surgical interventions for meniscal pathology. A methodologic protocol designed by Guyatt was used for the development. This measurement tool can be used as the primary outcome tool in clinical trials evaluating the outcome of patients in this population. It can also be used to monitor a patients’ progress in private practice. The purpose of this study was to develop a measure of quality of life, which is reliable and valid, to assess the benefit of conservative and surgical interventions for meniscal pathology. Health-related quality-of-life measurement tool development A modified methodologic protocol designed by Guyatt was used to develop the Western Ontario Meniscal Evaluation Tool (WOMET) a disease-specific quality of life measurement tool for patients with meniscal pathology. The stages were: 1) item generation, 3) item selection, 4) pretesting. Evaluation of the WOMET included testing reliability, responsiveness and validity. The final instrument, the Western Ontario Meniscal Evaluation Tool has sixteen items representing the domains of physical symptoms (nine items), sports, recreation/work/lifestyle (four items), and emotions (three items). The instrument proved to be valid by demonstrating predicted correlations with previously published knee measurement tools. Reliability at two weeks was high with an intraclass correlation coefficient of 0.833. The new instrument was also more responsive than other knee measurement tools. Since the patients own perception of changes in their health status is the most important indicator for success of a treatment, this measurement tool can be used as the primary outcome tool in clinical trials evaluating the outcome of patients in this population. It can also be used to monitor a patients’ progress in private practice
