Non-rheumatoid Wrist Arthritis Clinical Trial
Official title:
Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Randomized Study.
Verified date | February 2024 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the difference in the results between Motec and Remotion wrist arthroplasty in the treatment of non-rheumatoid wrist arthritis.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | November 2034 |
Est. primary completion date | November 2034 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Patients with painful non-rheumatoid wrist arthritis (posttraumatic arthritis and late stage Kienboeck's disease) - Age 18-70 years - ASA class 1-3 |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PRWHE (Patient rated Wrist and Hand Evaluation score) | PRWHE is a wrist specific patient assessed questionnaire, measuring pain, wrist specific function and general function | 24 months postop | |
Secondary | Wrist movement | Overall degree of flexion, extension, radial and ulnar deviation | 24 months postop | |
Secondary | Grip Strength | 24 months postop | ||
Secondary | Pain in affected wrist | Visual analogue scale | 24 months postop | |
Secondary | Quick-DASH | "Disabilities of the Arm, Shoulder and Hand" questionnaire | 24 months postop | |
Secondary | intraoperative complications | intraoperative | ||
Secondary | Postoperative complications | 24 months postop | ||
Secondary | Implant loosening | Implant loosening seen on x-ray | 24 months postop | |
Secondary | Implant migration | Implant migration seen on model-based roentgen stereophotogrammetric analysis (RSA), as a possible precursor of later implant loosening | 24 months postop | |
Secondary | Periprosthetic bone mineral density | BMD measured with DEXA (dual-energy x-ray absorptiometry) | 24 months postop | |
Secondary | Reoperations | Reoperations of any cause | 24 months postop |