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| Name | Class |
|---|---|
| Orthopedic Research and Education Foundation | OTHER |
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The data in this prospective registry will be used 1) to define which surgical and nonoperative techniques are most effective at providing pain relief, restoring function, are cost effective, and patients are satisfied with their outcomes; and 2) to design focused clinical questions regarding the optimal treatment of basal joint arthritis of the thumb in future randomized controlled trials. There are no interventions or changes in patient care associated with this study.
Basal joint arthritis of the thumb is a common condition associated with considerable morbidity. Many non-operative and operative treatments have been described but few multi-center prospective evidence based trials comparing standard treatments have been done. This continuing search for consensus of best clinical practices has been reviewed in a thorough meta-analysis of operative treatments for basal joint arthritis. Through the systematic collection of data regarding patient-specific characteristics, treatment interventions, and longitudinal functional outcome measurements the investigators believe patient outcomes and satisfaction can improve through the elucidation of risk factors for disease progression, and the timing and selection of treatment modalities, either conservative or surgical, for any particular patient. The establishment of a multi-center clinical registry will greatly facilitate these goals.
The study hypothesizes that there exist effective non-operative and operative treatments for certain patient populations with basal joint arthritis of the thumb. There also exists a functionally superior, cost effective, and low risk non-operative or minimally invasive operative treatment regime to alleviate pain and slow the progression of disease in those with less advanced disease. Likewise, there is significant functional, health utility, and economic advantage to surgically treating advanced basal joint arthritis with one of the popularized procedures currently in practice.
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| Measure | Description | Time Frame |
|---|---|---|
| Flexion/extension range of MCP joint | Range of motion measured in degrees of the metacarpophalangeal (MCP) joint. | Baseline, 6 weeks, 3 months, 6 months, 1 year |
| Flexion/extension range of IP joint | Range of motion measured in degrees of the interphalangeal (IP) joint. | Baseline, 6 weeks, 3 months, 6 months, 1 year |
| Grip strength | This will be quantified with use of a Jamar dynamometer set in the second position. | Baseline, 6 weeks, 3 months, 6 months, 1 year |
| Key-pinch strength | A 30-lb pinch dynamometer will used to determine lateral key-pinch strength. | Baseline, 6 weeks, 3 months, 6 months, 1 year |
| Tip-pinch strength | A 30-lb pinch dynamometer will used to determine lateral tip-pinch strength. | Baseline, 6 weeks, 3 months, 6 months, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Average total costs per patient | Review or estimation of hospital and office bills including those for the prescribed therapy and/or splinting will be tallied for each patient. | Up to 1 year |
| Disability of Arm, Shoulder and Hand (DASH) score |
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Inclusion Criteria:
Exclusion Criteria:
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The study subject population will consist of patients who are diagnosed with CMC arthritis of the thumb stages I, II, III, or IV. Recruitment of subjects will be the responsibility of the operating surgeon or a member of his clincal staff.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melvin P Rosenwasser, MD | Contact | 212 305 8036 | mpr2@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melvin P Rosenwasser, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Terminated | Rochester | Minnesota | 55905 | United States | |
| Columbia University/NY Presbyterian Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15277809 | Background | Martou G, Veltri K, Thoma A. Surgical treatment of osteoarthritis of the carpometacarpal joint of the thumb: a systematic review. Plast Reconstr Surg. 2004 Aug;114(2):421-32. doi: 10.1097/01.prs.0000131989.86319.b1. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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A questionnaire designed to assess musculoskeletal disorders of the upper limbs.
| Baseline, 6 weeks, 3 months, 6 months, 1 year |
| SF-36 questionnaire score | A questionnaire designed to validate general health: surveys physical functioning, performance in a physical role, performance in an emotional role, vitality, social functioning, bodily pain, general health perceptions, and mental health. | Baseline, 6 weeks, 3 months, 6 months, 1 year |
| Prevalence of arthritis progression | Radiographs will be performed classify each patient within the Eaton 102 osteoarthritis staging system. Sequential radiographs will be examined for progression of joint abnormalities. | Baseline, 6 weeks, 3 months, 6 months, 1 year |
| Recruiting |
| New York |
| New York |
| 10032 |
| United States |
|
| Vanderbilt University Hospital | Terminated | Nashville | Tennessee | 37232 | United States |