Study on Basal Joint Arthritis Prospective

Recruiting

• Conditions: Osteoarthrosis of the Carpometacarpal Joint of the Thumb

• Registration Number: NCT01376024
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-03-02
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients who have symptomatic basal joint arthritis.
• Patients who are capable of providing informed consent.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Flexion/extension range of MCP joint	Baseline, 6 weeks, 3 months, 6 months, 1 year	Range of motion measured in degrees of the metacarpophalangeal (MCP) joint.
Flexion/extension range of IP joint	Baseline, 6 weeks, 3 months, 6 months, 1 year	Range of motion measured in degrees of the interphalangeal (IP) joint.
Grip strength	Baseline, 6 weeks, 3 months, 6 months, 1 year	This will be quantified with use of a Jamar dynamometer set in the second position.
Key-pinch strength	Baseline, 6 weeks, 3 months, 6 months, 1 year	A 30-lb pinch dynamometer will used to determine lateral key-pinch strength.
Tip-pinch strength	Baseline, 6 weeks, 3 months, 6 months, 1 year	A 30-lb pinch dynamometer will used to determine lateral tip-pinch strength.

Secondary Outcome Measures

Name	Time	Method
Disability of Arm, Shoulder and Hand (DASH) score	Baseline, 6 weeks, 3 months, 6 months, 1 year	A questionnaire designed to assess musculoskeletal disorders of the upper limbs.
SF-36 questionnaire score	Baseline, 6 weeks, 3 months, 6 months, 1 year	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.
Average total costs per patient	Up to 1 year	Review or estimation of hospital and office bills including those for the prescribed therapy and/or splinting will be tallied for each patient.
Prevalence of arthritis progression	Baseline, 6 weeks, 3 months, 6 months, 1 year	Radiographs will be performed classify each patient within the Eaton 102 osteoarthritis staging system. Sequential radiographs will be examined for progression of joint abnormalities.

Trial Locations

Locations (3)

Columbia University/NY Presbyterian Hospital; 🇺🇸 New York, New York, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Vanderbilt University Hospital; 🇺🇸 Nashville, Tennessee, United States