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Interpositional arthroplasty is by many considered to be the current gold standard for the treatment of thumb carpometacarpal arthritis. The results are generally good, but the rehabilitation time can be long and failures are difficult to treat. Total joint replacements now exist with modern uncemented designs that can be an alternative treatment. Short term studies show that thumb function often is better and rehabilitation time shorter, however there is uncertainty with regards to the longevity of the implants. Currently no prospective randomized trials have compared these two treatment options. Our hypothesis is that the total joint replacement will give the same results or better when compared to the interpositional arthroplasty.
Eligible: patients >18 years with pain and dysfunction from the first cmc joint. Clinical and radiological arthritis.
Exclusion: degenerative changes in the STT joint (all patients are assessed by CT), other injuries in the hand/thumb, pregnancy
Outcome measures: quick-Dash, Nelson hospital score, range of motion, grip strength
Complications are registered.
The patients are observed for two years and the investigators aim to include a total of 40 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trapeziektomi and ligament interposition | Active Comparator | Interpositional arthroplasty Interpositional arthroplasty (Burton-Pellegrini procedure) |
|
| Total joint replacement | Experimental | Elektra CMC1 uncemented prosthesis Elektra prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interpositional arthroplasty (Burton-Pellegrini procedure) | Procedure | Burton-Pellegrini procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| quick-DASH | two-page questionnaire with VAS-scale for pain and function. | Baseline (preoperatively), and change from baseline postoperatively at 6 weeks, 3, 6, 12 and 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Nelson hospital score | one page thumb-specific questionnaire first published In Journal of Hand Surgery (Eur) 2007, 32E: 5: 524-528 | Baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Grip strength | Grip strength, key grip, tip-pinch measured by Jamar dynameter at each follow up | baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24months |
| range of motion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rasmus Thorkildsen, MBBS(Bsc) | Hand- and microsurgical unit, Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital, Rikshospitalet | Oslo | 0021 | Norway |
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| Total joint replacement | Procedure | Total joint replacement |
|
|
| Elektra prosthesis | Device | Elektra prosthesis |
|
Range of motion measured clinically (Kapandji opposition) and by x-ray (abduction, adduction, extension and flexion) at follow-up
| baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months |
| complications | complications to either treatment form will be registered and published | registered at 2 and 6 weeks. Thereafter at 3,6, 12 and 24 months. |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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