NCT01376024

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.

Trial Health

53
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Mar 2007

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Mar 2007Aug 2026

Study Start

First participant enrolled

March 2, 2007

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
15.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

19.4 years

First QC Date

June 16, 2011

Last Update Submit

June 4, 2025

Conditions

Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Keywords

Carpometacarpal arthritisBasal joint arthritisCMC arthritisOsteoarthritis

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (4)

  • Average total costs per patient

    Up to 1 year

  • Disability of Arm, Shoulder and Hand (DASH) score

    Baseline, 6 weeks, 3 months, 6 months, 1 year

  • SF-36 questionnaire score

    Baseline, 6 weeks, 3 months, 6 months, 1 year

  • Prevalence of arthritis progression

    Baseline, 6 weeks, 3 months, 6 months, 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Columbia University/NY Presbyterian Hospital

New York, New York, 10032, United States

Location

Vanderbilt University Hospital

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • 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.

    PMID: 15277809BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Melvin P Rosenwasser, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 20, 2011

Study Start

March 2, 2007

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(3)