Status:
UNKNOWN
Patient Reported Outcome After Stemmed Versus Stemless Total Shoulder Arthroplasty for Glenohumeral Osteoarthritis.
Lead Sponsor:
Zealand University Hospital
Collaborating Sponsors:
Hvidovre University Hospital
Conditions:
Shoulder Pain
Shoulder Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Glenohumeral joint osteoarthritis is a common cause of shoulder pain, affecting up to one-third of patients older than 60 years. Surgical treatment is indicated for patients with glenohumeral arthriti...
Eligibility Criteria
Inclusion
- 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
- 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.
- Brachial plexus palsy.
- 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.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT03877315
Start Date
August 1 2019
End Date
August 1 2023
Last Update
December 22 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zealand University Hospital
Køge, Denmark, 4600