The Effect of Postoperative "Peanut Ball" Rehabilitation After Total Knee Replacement.
Knee OsteoarthritisThe purpose of this randomized controlled study is to evaluate the effect of postoperative exercise with a "peanut ball" after total knee replacement, on pain, intake of pain killers, knee function, and health-related quality of life.
Safety Study of PTP-001 for Treating Knee Osteoarthritis
Knee OsteoarthritisEvaluation of safety, tolerability, and efficacy of a single intra-articular (IA) injection of PTP-001, an allogeneic placental tissue particulate, in individuals with knee osteoarthritis (OA).
Study to Evaluate Intra-articular Resiniferatoxin to Treat Moderate to Severe Pain From Knee Osteoarthritis...
OsteoarthritisKnee2 moreThis study evaluates the efficacy and safety of a single IA injection of various RTX doses, Zilretta or placebo for the treatment of pain due to moderate to severe osteoarthritis knee pain..
A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee...
OsteoarthritisKneeThis study is designed as a long-term extension to the Phase 3 parent-study SM04690-OA-11. It aims to evaluate the safety and efficacy of long-term use of lorecivivint (LOR) in subjects with knee osteoarthritis (OA). The first 48 weeks will be single-blind and placebo-controlled while the remainder of the study will be open-label and uncontrolled. Subjects must enroll no later than 6 weeks following completion of the parent-study.
The THumb Osteoarthritis Exercise TriAl
Thumb OsteoarthritisSummary: OBJECTIVE(S)/RESEARCH QUESTION(S) Does an orthosis combined with exercise therapy results in less pain and less conversion to surgery than an orthosis alone in patients with first carpometacarpal osteoarthritis (CMC-1 OA), at three months and one year after the start of treatment? HYPOTHESIS We hypothesize that the orthosis + exercise therapy group has less pain and conversion to surgery will be lower than the orthosis group. STUDY DESIGN Randomized controlled multicenter trial STUDY POPULATION(S)/DATASETS Patients with irst carpometacarpal osteoarthritis (CMC-1 OA) seeking treatment INTERVENTION Orthosis + exercise therapy USUAL CARE/COMPARISON Orthosis only OUTCOME MEASURES Primary outcomes: pain and conversion to surgery SAMPLE SIZE CALCULATION/DATA ANALYSIS Two groups of 80 participants; analysis based on repeated measures analysis (for pain) and chi-squared (for conversion to surgery). We initially planned to perform a logistic regression for conversion to surgery but decided prior to data analysis that we will be using Chi-square tests to determine whether there is a between-group difference in the proportion converting to surgery. We will use a repeated measures analysis for pain. COST-EFFECTIVENESS ANALYSIS (CEA)/ BUDGET IMPACT ANALYSIS (BIA) Economic evaluation will be done from societal & healthcare perspectives, according cost-effectiveness analysis (CEA) guidelines. Medical & non-medical costs and consequences (i.e. productivity loss) will be collected and taken into account. Both CEA and cost-utility analysis will be performed, using conversion to surgery and Quality-adjusted life years (QALYs), respectively TIME SCHEDULE Start preparation: December 2019, inclusion: October 2020- December 2022, final report: December 2023
Whole-Body Electromyostimulation and Knee Osteoarthritis
OsteoarthritisKneeThe aim of the present study is to evaluate the effects of WB-EMS application in overweight women and men with knee osteoarthritis, with special consideration of sustainability. In this randomised controlled trial 72 overweight patients with knee osteoarthritis aged 40-70 years will be included and randomly assigned to two groups (WB-EMS vs. control group (CG)). The intervention group will perform six WB-EMS sessions/month of 20 min for 6 months. An intermittent low frequency WB-EMS-protocol with an impulse phase of 6s, followed by an impulse break of 4s will be applied. The control group will undergo a tailored physiotherapy program of 6 sessions defined as usual care. In addition, both groups will complete a self-management training programme for osteoarthritis of 6 sessions over 12 weeks.
Impact of High Tibial Osteotomy in Preventing Degenerative Disease Progression in Medial Knee Osteoarthritis....
Knee OsteoarthritisCartilage Degeneration2 moreHigh tibial osteotomy (HTO) surgical procedure can lead to clinically significant improvements in the cartilage and in subchondral bone quality, with a slow down of the osteoarthritis (OA) progression. Aim of the project is to: (i) clinically validate a 3D planned HTO surgical approach, through a quantitative grading of OA progression in a prospective randomized case-control clinical trial; (ii) correlate the internal knee loads with the changes assessed in cartilage and subchondral bone status to verify the hypothesis that HTO induced mechanical changes are associated with clinically significant OA improvements; (iii) relate imaging data with cartilage and subchondral bone mechanical properties, in order to classify OA progression in a more sensitive manner and allow a more precise diagnosis of the pathology stage.
iPACK Block for Total Knee Arthroplasty
Knee OsteoarthritisKnee Pain Chronic1 moreThis randomized, double-blinded, placebo-controlled trial seeks to evaluate the efficacy of the rehabilitation process of the Interspace between the Popliteal Artery and Capsule of the Posterior Knee (iPACK) block in total knee arthroplasty.
GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study
OsteoarthritisPost Traumatic ArthritisThis is a Post Market Clinical Follow Up (PMCF) study to monitor the safety and performance of the GLOBAL ICON stemless humeral component. The data gathered will be used to support post market surveillance of the device, and may potentially be used for additional market access purposes.
Fitmore Versus CLS Stem in Total Hip Arthroplasty. Bilateral One-stage Operations
Primary Hip OsteoarthritisSecondary Hip Osteoarthritis Due to Idiopathic Femoral Head Necrosis3 moreMain question: Will use of a stem design that allows anatomical reconstruction of the hip joint improve the outcome in terms of hip function and patient satisfaction without causing any adverse effects? Background: Total hip arthroplasty with use of the most well documented implants is a safe and cost-effective procedure. In the Swedish Hip Arthroplasty register the CLS stem has a 16 years implant survival of 97, 5 %. It is a classic design which requires resection of most of the neck. The stem also intrudes into the greater trochanter which in patients with certain types of proximal hip anatomy makes proper introduction of the stem difficult. Finally it has a standard stem length which will jeopardise future stem removal should there occur any late infection or instability problems. Short uncemented stems have been introduced to enable a more anatomic reconstruction of the hip joint and to cause less invasion of the femoral canal to facilitate future revision should it be necessary. A more conservative resection of neck could also be of value to improve the clinical outcome by improved hip function and patient satisfaction. Purpose of the present study and design: In a prospective study the clinical outcome, stem fixation and bone remodelling around a short stem (Fitmore) will be studied. The main focus will be to evaluate patient reported outcomes especially concerning function, over all satisfaction, pain and activity. All patients will receive the same cup (Trilogy). This cup is chosen because it has a very thorough documentation in prospective RSA studies and in the Swedish hip arthroplasty register. All cups will be supplied with insert made of high molecular polyethylene (Longevity). Number of hips in the study: 44 consecutive cases