Clinical trial NCT01376024: Study on Basal Joint Arthritis Prospective
Official title: Multicenter Prospective Study on Basal Joint Arthritis of the Thumb
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Osteoarthrosis of the Carpometacarpal Joint of the Thumb
Keywords: Carpometacarpal arthritis
Basal joint arthritis
CMC arthritis
Osteoarthritis
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Orthopedic Research and Education Foundation
First posted: 2011-06-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Flexion/extension range of MCP joint
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 1 year
measure: Flexion/extension range of IP joint
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 1 year
measure: Grip strength
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 1 year
measure: Key-pinch strength
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 1 year
measure: Tip-pinch strength
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 1 year
Secondary outcomes:
measure: Average total costs per patient
timeFrame: Up to 1 year
measure: Disability of Arm, Shoulder and Hand (DASH) score
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 1 year
measure: SF-36 questionnaire score
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 1 year
measure: Prevalence of arthritis progression
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Columbia University/NY Presbyterian Hospital
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Hospital
state: Tennessee
Study officials:
affiliation: Columbia University
name: Melvin P Rosenwasser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.