Study on Basal Joint Arthritis Prospective
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who have symptomatic basal joint arthritis.
Patients who are capable of providing informed consent.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Flexion/extension range of MCP joint
Range of motion measured in degrees of the metacarpophalangeal (MCP) joint.
Time frame
Baseline, 6 weeks, 3 months, 6 months, 1 year2
Flexion/extension range of IP joint
Range of motion measured in degrees of the interphalangeal (IP) joint.
Time frame
Baseline, 6 weeks, 3 months, 6 months, 1 year3
Grip strength
This will be quantified with use of a Jamar dynamometer set in the second position.
Time frame
Baseline, 6 weeks, 3 months, 6 months, 1 year4
Key-pinch strength
A 30-lb pinch dynamometer will used to determine lateral key-pinch strength.
Time frame
Baseline, 6 weeks, 3 months, 6 months, 1 yearSecondary outcomes
1
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.
Time frame
Up to 1 year2
Disability of Arm, Shoulder and Hand (DASH) score
A questionnaire designed to assess musculoskeletal disorders of the upper limbs.
Time frame
Baseline, 6 weeks, 3 months, 6 months, 1 year3
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.
Time frame
Baseline, 6 weeks, 3 months, 6 months, 1 year4
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.
Time frame
Baseline, 6 weeks, 3 months, 6 months, 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Orthopedic Research and Education Foundation
Collaborator
Source ClinicalTrials.gov