Clinical Research Directory

Poly vs Hybrid Glenoid in Stemless aTSA

Participants are randomized 1:1 to receive either a cemented all-polyethylene pegged glenoid or a hybrid trabecular titanium-pegged glenoid during anatomic total shoulder arthroplasty. Multicentre, stratified block randomization with variable block sizes; patient- and assessor-blinded.

Performance and Safety of HyalganBio® Intra-Articular Injections as Add-On to Physical Exercise for Symptomatic Glenohumeral Osteoarthritis

This investigation evaluates performance and safety of three intra-articular injections of HyalganBio®, combined with a Physical Exercise Program (PEP) in subjects with glenohumeral osteoarthritis. The main goal is to see whether patients improve shoulder function six months after the first injection, compared with patients who only follow the exercise program. Improvement is measured using the Constant-Murley Score (CMS). Participants first attend a screening visit and, if they meet all criteria, they are enrolled. Within 14 days, they are randomly assigned to one of two groups: group 1 receives three weekly HyalganBio® injections and performs the PEP three times a week for 60 days, recording adherence in a diary; group 2: performs the same PEP schedule and also records adherence in a diary. Follow-up visits take place at 2, 4, and 6 months after the first injection, with additional telephone check-ins at 1 and 3 months.

Pyrocarbon Hemiarthroplasty Versus Total Shoulder Arthroplasty for the Treatment of Glenohumeral Osteoarthritis

This is a multi-center study assessing postoperative outcomes associated with hemiarthroplasty with pyrocarbon (hPYC) versus anatomic total shoulder arthroplasty (aTSA). Once eligibility criteria is met, the subject will be randomized to one of the two study arms. Subjects will be followed for ten years. Clinical and patient-reported outcome measures (PROMs) will be assessed.

ZILRETTA in Subjects With Shoulder Osteoarthritis

Primary Objective: To assess the efficacy of ZILRETTA on pain following an intra-articular (IA) injection in subjects with glenohumeral osteoarthritis (OA) relative to normal saline placebo Secondary Objective: * To assess the efficacy of ZILRETTA on pain following an IA injection in subjects with glenohumeral OA relative to triamcinolone acetonide injectable suspension, and normal saline placebo * To assess the safety of ZILRETTA in subjects with glenohumeral OA relative to normal saline placebo

Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis

Anatomical total shoulder arthroplasty (TSA) is a well-established treatment for pronounced glenohumeral osteoarthritis. However, the effectiveness of TSA has not been compared to non-surgical treatment in a randomised controlled trial. Shoulder exercises may be an effective treatment for reducing pain and improving function in glenohumeral osteoarthritis. The primary aim of this trial is to examine if TSA followed by standard postsurgical rehabilitation is superior to a 12-week exercise programme in patients with primary glenohumeral OA eligible for unilateral TSA. We hypothesise that surgical intervention followed by standard rehabilitation, results in clinically relevant (18-point, on a scale from 0-100) improvement compared to the exercise intervention.