Study on Basal Joint Arthritis Prospective

NCT ID: NCT01376024

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-02
• Study Completion Date: 2026-08-31

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.

Conditions

Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthopedic Research and Education Foundation

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melvin P Rosenwasser, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Mayo Clinic

Rochester, Minnesota, United States

Columbia University/NY Presbyterian Hospital

New York, New York, United States

Vanderbilt University Hospital

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15277809 (View on PubMed)

Other Identifiers

AAAC0826

Identifier Type: -

Identifier Source: org_study_id