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Non achievement of the estimated sample size of the group silicone arthroplasty in a reasonable recruitment time.
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The operational and favored standard therapy for the treatment of osteoarthritis in the distal interphalangeal joint is the arthrodesis, in which a titanium screw is used. Arthrodesis shows in the most cases the complete reduction of osteoarthritis pain and low loss of function. But restrictions are reported in fine motor skills.
The operation with silicone arthroplasty is similar. As an implant, a silicone joint is used, which has been sufficiently tested at the metacarpophalangeal joint and interphalangeal joint. The advantage of arthroplasty is the function obtained in the distal interphalangeal joint and the resulting improved fine motor skills.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| silicone arthroplasty | Experimental | silicone arthroplasty |
|
| arthrodesis | Active Comparator | arthrodesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silicone arthroplasty | Procedure | silicone arthroplasty |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Michigan Hand Questionnaire (MHQ) | Comparison of silicone arthroplasty and arthrodesis in respect to MHQ | 12 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Michigan Hand Questionnaire Score | preoperative, 3mo/6mo/36mo postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Change of objective clinical parameters | measurements of grip strength and range of motion | preoperative, 3mo/6mo/12mo/36mo postoperative |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schulthess Klinik | Zurich | 8008 | Switzerland |
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| ID | Term |
|---|---|
| D001174 | Arthrodesis |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| arthrodesis |
| Procedure |
arthrodesis |
|