Early Migration of Stemless and Stemmed Humeral Components After Total Shoulder Arthroplasty for Osteoarthritis - A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Herlev and Gentofte Hospital
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Radiostereometric analysis (RSA)
Study Overview
Brief Summary
This is a randomized controlled trial comparing the Comprehensive Nano stemless total shoulder arthroplasty (intervention group) with the Comprehensive un-cemented stemmed total shoulder arthroplasty (control group). All Danish citizens with glenohumeral osteoarthritis indicating a total shoulder arthroplasty referred to the orthopedic department at Copenhagen University Hospital in Gentofte will be offered participation in the trial. The following exclude from participation in the study: below 18 years of age; cognitive or linguistic impairment; insufficient function of the rotator cuff; poor bone quality and ASA group 4-5. A total of 122 patients will be included of which 56 will be part of radiostereometric analysis (RSA) study of humeral component migration. This will allow a maximum of 20% drop out. The primary outcome is magnitude and pattern of migration of the humeral component assessed by RSA. The secondary outcomes are patient-reported outcomes, functional outcome, readmission, complications, revisions, changes in bone mineral density (BMD) of the proximal humerus assessed by duel energy x-ray absorptiometry (DXA) and economy (cost utility analysis). To avoid bias in some of these outcomes, the patient will not know what type of humeral component was used. The patients are examined before the operation and 3, 6, 12 and 24 months after the operation.
Detailed Description
Background Osteoarthritis (wear and tear) of the shoulder can, in the most severe cases, require insertion of shoulder prosthesis (an artificial shoulder joint, a total shoulder arthroplasty). This is an effective treatment with pain-relief and significant improvement in shoulder function. A design with a metal stem in the humeral bone canal is currently regarded as the best treatment option, but complications related to the stem including humeral fractures can have devastating consequences. By using a stemless humeral component stem-related complications can be reduced. Furthermore, the canal preserving design may also facilitate further surgery should the need of a revision prosthesis arise.
Currently, little is known about the results of the stemless design. The initial results have been promising, but as with the stemmed design migration and eventually loosening of the prosthesis can lead to poor results and, in some cases, revision.
Using radiostereometric analysis (RSA) a special x-ray examination technique based upon insertion of small metal beads into the bone surrounding an implant and attachment of beads to the prosthesis (or using 3-dimensional models of the implant (CAD models) = model-based RSA (MB-RSA)), implant migration can be measured extremely accurate. The RSA technique has previously been used to study migration and loosening of hip and knee prostheses. It has been suggested that RSA should be used to monitor small series of new prostheses the first two years after surgery as a part of a safe phased introduction.
RSA has never been used to access migration of a stemmed or a stemless humeral component nor has the stemmed and the stemless humeral component been compared with regard to pain relief and shoulder function.
Purpose The purpose is to compare the Comprehensive Nano stemless total shoulder prosthesis (intervention group) with the Comprehensive stemmed total shoulder prosthesis (control group).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All Danish citizens with glenohumeral osteoarthritis indicating a total shoulder arthroplasty referred to the orthopedic department at Copenhagen University Hospital in Gentofte
Exclusion Criteria
- •below 18 years of age
- •cognitive or linguistic impairment
- •insufficient function of the rotator cuff
- •poor bone quality
- •ASA group 4-5
Arms & Interventions
Un-cemented Comprehensive Nano stemless shoulder arthroplasty
By using a stemless humeral component stem-related complications can be reduced. Furthermore, the canal preserving design may also facilitate further surgery should the need of a revision prosthesis arise.
Currently, little is known about the results of the stemless design. The initial results have been promising, but as with the stemmed design migration and eventually loosening of the prosthesis can lead to poor results and, in some cases, revision
Intervention: Shoulder arthroplasty (Procedure)
Un-cemented Comprehensive stemmed total shoulder arthroplasty
A design with a metal stem in the humeral bone canal is currently regarded as the best treatment option, but complications related to the stem including humeral fractures can have devastating consequences.
Intervention: Shoulder arthroplasty (Procedure)
Outcomes
Primary Outcomes
Radiostereometric analysis (RSA)
Time Frame: Change from 1 week postoperatively to 3 months, 6 months, and at 1 and 2 years postoperatively
A special x-ray examination technique based upon insertion of small metal beads into the bone surrounding an implant and attachment of beads to the prosthesis (or using 3-dimensional models of the implant (CAD models) = model-based RSA (MB-RSA)). In this way, implant migration can be measured extremely accurate.
Western Ontario Osteoarthritis of the Shoulder index (WOOS)
Time Frame: Change in WOOS score from preoperatively to 3 months, 6 months, and at 1 and 2 years postoperatively
The WOOS is a disease-specific patient-reported outcome (Lo IK et al 2001). There are 19 questions divided into four domains: Physical symptoms, sports and work, lifestyle and emotions. Each question is answered on a visual analogue scale ranging from 0 to 100. The overall score ranges from 0 to 1900, with 1900 being the worst. For ease of interpretation, the scores are converted to a percentage of the maximum score. We use a Danish version of WOOS (Rasmussen JV et al 2013) which was translated according to the guidelines of Guillemin, Bombardier and Beaton (Guillemin F et al 1993). It was validated with classical test theory in a cohort of patients treated with shoulder arthroplasty for osteoarthritis.
Secondary Outcomes
- Side effects and complications(2 years postoperatively)
- Plain radiographs(Preoperatively and at 1 week, 3 months and at 1 and 2 years postoperatively)
- Length of hospital stay(3 months postoperatively)
- Discharge destination(3 months postoperatively)
- Duel energy x-ray absorptiometry (DXA)(Preoperatively and at 1 week, 3 months, 6 months, and at 1 and 2 years postoperatively)
- Oxford Shoulder Score (OSS)(Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively)
- Pain and patient-satisfaction: visual analogue scale (VAS)(3 months, 6 months, and at 1 and 2 years postoperatively)
- Constant-Murley score(Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively)
- Cost-utility analysis(2 years postoperatively)
- Pain medication usage(2 years postoperatively)
Investigators
Marc Randall Kristensen Nyring
Principal investigator, PhD student
Herlev and Gentofte Hospital