Osteoarthrosis of the Carpometacarpal Joint of the Thumb Clinical Trial
— BJAMOfficial title:
Multicenter Prospective Study on Basal Joint Arthritis of the Thumb
NCT number | NCT01376024 |
Other study ID # | AAAC0826 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 2, 2007 |
Est. completion date | August 31, 2025 |
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | August 31, 2025 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Hospital | Nashville | Tennessee |
United States | Columbia University/NY Presbyterian Hospital | New York | New York |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Orthopedic Research and Education Foundation |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Disability of Arm, Shoulder and Hand (DASH) score | A questionnaire designed to assess musculoskeletal disorders of the upper limbs. | Baseline, 6 weeks, 3 months, 6 months, 1 year | |
Secondary | 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 | |
Secondary | 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 |
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