Study on Basal Joint Arthritis Prospective (BJAM)

Multicenter Prospective Study on Basal Joint Arthritis of the Thumb

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.

Study Overview

• Status: Suspended
• Conditions: Osteoarthrosis of the Carpometacarpal Joint of the Thumb

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10032
      • Columbia University/NY Presbyterian Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Orthopedic Research and Education Foundation
• Investigators: Principal Investigator: Melvin P Rosenwasser, MD, Columbia University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2007
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: June 16, 2011
• First Submitted That Met QC Criteria: June 17, 2011
• First Posted (Estimated): June 20, 2011

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Osteoarthritis; CMC arthritis; Carpometacarpal arthritis; Basal joint arthritis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: AAAC0826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No