Basal Joint Arthritis Prospective (BJAM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Columbia University
Sponsor:
Collaborators:
Arthritis Foundation
American Society for Surgery of the Hand
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT01376024
First received: June 16, 2011
Last updated: November 2, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376024

Contacts
Contact: John W Karl, MD, MPH 212-305-3912 jwk2115@columbia.edu

Locations
United States, New York
Columbia University/NY Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Arthritis Foundation
American Society for Surgery of the Hand
Investigators
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 September 29, 2014