Basal Joint Arthritis Prospective (BJAM)
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Purpose
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.
Arthritis at the base of the thumb is a common condition associated with considerable patient discomfort. Many non-operative and operative treatments have been described, but few prospective studies involving multiple centers comparing these treatments have been done. By following patients from the start of their arthritis treatment and assessing their progress at certain time points using questionnaires and radiographs the investigators believe patient outcomes and satisfaction can improve. This study will include patients who are treated non-operatively and operatively and will not change patients' standard of care. By establishing standardized outcome measures and collecting data prospectively from the time of initial presentation through all treatment interventions it will be possible to directly compare treatments during the conservative and operative care of basal joint arthritis of the thumb. This multi-center study will identify those specific procedures or conservative treatments that have the greatest potential to be studied in subsequent focused and well-designed randomized control trials.
| Condition |
|---|
|
Osteoarthritis of the Basal Joint of the Thumb |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Multicenter Prospective Study on Basal Joint Arthritis of the Thumb |
- Pain Relief [ Time Frame: Initially, up to 1 year ] [ Designated as safety issue: No ]Subject may have annual assessments after the 1st year.
- Functional strength-dexterity [ Time Frame: Initially, up to 1 year ] [ Designated as safety issue: No ]Subject may have annual assessments after the 1st year.
- Cost effectiveness [ Time Frame: Initially, up to 1 year ] [ Designated as safety issue: No ]Subject may have annual assessments after the 1st year.
- Patient satisfaction [ Time Frame: Initially, up to 1 year ] [ Designated as safety issue: No ]Subject may have annual assessments after the 1st year.
| Estimated Enrollment: | 500 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- Patients who have symptomatic basal joint arthritis.
- Patients who are capable of providing informed consent
Exclusion Criteria:
- Patients younger than 18 years old at the time of enrollment
- Patients with neuromuscular disease affecting the operated hand, not caused by the CMC operation
- Patients with known inflammatory arthritic conditions, such as rheumatoid or psoriatic arthritis
- Patients with a history of or current infection of the basal joint of the affected hand.
- Patients who are demented or are unable to provide informed consent.
- Patients unable to comply with study guidelines.
- Patients who have metacarpophalangeal joint hyperextension are NOT excluded. These patients will be followed and if they receive a capsulodesis or other procedure at the MCPJ at the same time as their basal joint arthroplasty this will be noted in their data records.
Contacts and Locations| Contact: John W Karl, MD, MPH | 212-305-3912 | jwk2115@columbia.edu |
| United States, New York | |
| Columbia University/NY Presbyterian Hospital | Recruiting |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Melvin P Rosenwasser, MD | Columbia University |
More Information
Publications:
| Responsible Party: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT01376024 History of Changes |
| Other Study ID Numbers: | AAAC0826 |
| Study First Received: | June 16, 2011 |
| Last Updated: | November 2, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Columbia University:
|
Carpometacarpal arthritis Basal joint arthritis CMC arthritis Osteoarthritis |
Additional relevant MeSH terms:
|
Arthritis Osteoarthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013