Joint Replacement or Interpositional Arthroplasty for CMC1 Arthritis, a Prospective Trial
NCT02556515
Arthritis, Joint Diseases
Oslo, Norway
View Trial DetailsNCT Number: NCT01376024
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Mayo Clinic, Rochester, Minnesota, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
Range of motion measured in degrees of the metacarpophalangeal (MCP) joint.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
Range of motion measured in degrees of the interphalangeal (IP) joint.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
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 year
A 30-lb pinch dynamometer will used to determine lateral key-pinch strength.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
A 30-lb pinch dynamometer will used to determine lateral tip-pinch strength.
Time frame: Up to 1 year
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: Baseline, 6 weeks, 3 months, 6 months, 1 year
A questionnaire designed to assess musculoskeletal disorders of the upper limbs.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
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 year
Radiographs will be performed classify each patient within the Eaton 102 osteoarthritis staging system. Sequential radiographs will be examined for progression of joint abnormalities.
Contact information is provided by the study sponsor or research team.
Columbia University
Other
Prospective Study on Basal Joint Arthritis of the Thumb
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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