Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint
- Conditions
- Osteoarthritis
- Interventions
- Procedure: Total joint arthroplasty
- Registration Number
- NCT01554748
- Lead Sponsor
- Regional Hospital Holstebro
- Brief Summary
The study evaluates implant survival in total joint arthroplasty of the Trapeziometacarpal (TMC) joint by monitoring the survival of different implant types using radiostereometry (RSA) evaluation of the implants.
- Detailed Description
The study evaluates implant survival and clinical outcome in total joint arthroplasty of the TMC joint. Different implant designs are included in the study both cemented and uncemented implants. Also the influence of patient factors and surgical technique on implant survival is investigated. The primary outcome is implant migration and loosening. Evaluation is done by monitoring migration and loosening of different implant types using RSA evaluation of the implants. Secondary outcomes are patient reported function evaluated with the Disability of the arm, shoulder and hand score (DASH) and visual analog pain score (VAS). Tertiary outcome is range of movement (ROM) plus grip strength.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- Patients with Eaton type 2+3 TMC osteoarthritis
- Patients with Eaton type 4 TMC osteoarthritis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patient cohort Total joint arthroplasty TMC total joint arthroplasty
- Primary Outcome Measures
Name Time Method Implant survival 10 year survival Revision with removal of implant
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Orthopaedics, Regional Hospital Holstebro
🇩🇰Holstebro, Denmark