Glenohumeral Osteoarthritis Clinical Trial
Official title:
Early Migration of Stemless and Stemmed Humeral Components After Total Shoulder Arthroplasty for Osteoarthritis - A Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 122 |
Est. completion date | February 28, 2025 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Herlev and Gentofte Hospital | Hellerup |
Lead Sponsor | Collaborator |
---|---|
Herlev and Gentofte Hospital |
Denmark,
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* Note: There are 51 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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)). In this way, implant migration can be measured extremely accurate. | Change from 1 week postoperatively to 3 months, 6 months, and at 1 and 2 years postoperatively | |
Primary | Western Ontario Osteoarthritis of the Shoulder index (WOOS) | 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. | Change in WOOS score from preoperatively to 3 months, 6 months, and at 1 and 2 years postoperatively | |
Secondary | Duel energy x-ray absorptiometry (DXA) | Changes in bone mineral density (BMD) in close relation to an orthopedic implant can be measured by duel x-ray absorptiometry (DXA) | Preoperatively and at 1 week, 3 months, 6 months, and at 1 and 2 years postoperatively | |
Secondary | Plain radiographs | We use an anterior-posterior and a lateral view. The radiographs are used to evaluate the position of the component and to evaluate loosening as the cause of failure. | Preoperatively and at 1 week, 3 months and at 1 and 2 years postoperatively | |
Secondary | Oxford Shoulder Score (OSS) | Oxford Shoulder Score (OSS): The OSS was conceived as a measurement tool for the assessment of pain and function after elective shoulder surgery (Dawson J et al 1996). There are 12 questions with each item scored from 1-5. The overall score ranges from 12 to 60, with 60 being the worst. For ease of interpretation, the scores are converted to a percentage of the maximum score. We use a Danish version of OSS which was translated and validated with classical test theory (Frich LH et al 2011). | Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively | |
Secondary | Constant-Murley score | The Constant-Murley Score includes an assessment of: pain; activities of daily living (ADL); range of motion; and strength. There are a possible 35 points given for the subjective assessment of pain and the ability to perform ADL. There are a possible 65 points given for an objective assessment, of which 40 points are allocated to range of motion and 25 points are allocated to strength. The maximum of 100 point indicates a shoulder with no disability. We use a Danish version (Ban I et al 2013) of the modified score described by ConĀ¬stant and colleagues in 2008 (Constant CR et al 2008). | Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively | |
Secondary | Pain and patient-satisfaction: visual analogue scale (VAS) | Pain is answered on a visual analogue scale (VAS) ranging from 0 to 10, with 10 being the worst. Patients are asked to categorize the result as excellent, very good, good, fair and poor. | 3 months, 6 months, and at 1 and 2 years postoperatively | |
Secondary | Side effects and complications | We will record any case of medical complications (embolism, cardiovascular event, pneumonia) and complications related to the surgical procedure (fractures, nerve injuries, deep and superficial infections, malpositioning of the components, instability, and dislocation) and revisions defined by removal or exchange of any component. | 2 years postoperatively | |
Secondary | Cost-utility analysis | In modern health economics, thresholds have been estimated for acceptable cost-utility ratios - the threshold for how much health care providers will pay for an extra quality- adjusted life year (QALY). In England and in Europe, the threshold for an extra QALY is set at 20,000-30,000 pounds and 30,000 Euros respectively. The cost utility of the Comprehensive Nano stemless shoulder arthroplasty will be compared with these thresholds and with the cost utility of the uncemented Comprehensive stemmed total shoulder arthroplasty. The EQ-5D will be used to estimate QALY for individual patients. | 2 years postoperatively | |
Secondary | Length of hospital stay | How long time the patients are hospitalized postoperatively. The data will be extracted from the medical records. | 3 months postoperatively | |
Secondary | Discharge destination | Whether the patients are discharged to home, rehabilitation or nursing home. The data will be extracted from the medical records. | 3 months postoperatively | |
Secondary | Pain medication usage | Which kind and how much pain medication each patients have used. The data will be extracted from the medical records. | 2 years postoperatively |
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