Patient Reported Outcome After Stemmed Versus Stemless Total Shoulder Arthroplasty for Glenohumer… (NCT03877315) | Clinical Trial Compass
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Patient Reported Outcome After Stemmed Versus Stemless Total Shoulder Arthroplasty for Glenohumeral Osteoarthritis.
Denmark78 participantsStarted 2019-08-01
Plain-language summary
Stemless shoulder arthroplasty systems with uncemented metaphyseal fixation have been used in Europe for glenohumeral osteoarthritis since 2004. The stemless design has several theoretical advantages compared with the stemmed shoulder arthroplasty systems: restoring patients' anatomy, preserving humeral bone stock, and few complications in component removal if the need for a revision arthroplasty arises. The purpose of the study is to compare the short-term, patient-reported outcome of stemless and stemmed total shoulder arthroplasty.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients aged ≥ 18 years.
✓. Patients have been referred to the Orthopedic Department or Zealand University Hospital, Koege or Hvidovre University Hospital for shoulder pain during the study period.
✓. Patients have the ability to read trial information in Danish and give informed consent.
✓. The diagnosis will be based on plain radiographs (at least two perpendicular views), reduction of joint space, and/or osteophyte formation.
✓. Clinical presentation with pain at night and/or daily pain, pain in overhead activity, and consumption of pain medication.
Exclusion criteria
✕. Previous shoulder surgery that involves the humeral head and/or the glenoid cavity.
✕. Patients with alcohol or drug abuse problems that can compromise rehabilitation and follow-up appointments as assessed by the recruiting surgeon at the first visit.
✕. Patients unable to understand instructions in Danish, follow the rehabilitation protocol, or answer the questionnaires because of physical or cognitive inabilities as evaluated by the recruiting surgeon at the first visit.
What they're measuring
1
Western Ontario Osteoarthritis of the Shoulder Score (WOOS)
✕. Patients with previous fractures around the shoulder (clavicle, scapula, and proximal humerus fractures).
✕. Patients with MRI scan-verified full thickness total tear of one or more of the rotator cuff tendons.
✕. Patients with CT scan-verified glenoid retroversion ≥ 20° that does not allow glenoid component fixation without bone graft or need an augmented glenoid component.