New York, New York 10032


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.


Study summary:

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. 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 proposed multi-center registry will identify those specific procedures or conservative treatments that have the most potential to be studied in subsequent focused and well-designed randomized control trials. Osteoarthritis is the most common form of arthritis and the second most frequent cause of long-term disability in North America. Osteoarthritis of the basal joint of the thumb is a debilitating disease that affects a large segment of the adult population, although no large epidemiologic studies on the prevalence of basal joint arthritis have been performed in the United States. The pathogenesis of osteoarthritis remains multi-factorial but most researchers agree that it is a degenerative process resulting from mechanical, biochemical, and genetic factors that destabilize the normal balance of degradation and synthesis of articular cartilage and subchondral bone. Although there are some excellent studies with randomized, prospective design showing good outcomes with several surgical techniques, it is still unknown which procedures are the most appropriate for a particular patient to achieve the optimal functional outcome and long-term success with minimal surgical trauma. Optimal immobilization type and duration is also not known. The effect of metacarpalphalangeal joint hyperextension on long-term outcomes and the optimal treatment method for this adjacent joint is also unknown. This proposed study will allow prospective data collection from multiple institutions across the country and engage recognized experts, all of whom treat basal joint arthritis with different clinical protocols. Millions of people in the U.S. have or will develop basal joint osteoarthritis, which is the most commonly affected joint in the upper extremity that requires surgical intervention. The demand for a more efficacious and cost effective form of operative and non-operative treatment of this disabling disease is considerable. Identifying safe and effective treatments from among the numerous treatment modalities available would likely lead to significant improvements in the quality of life for a large segment of this population. If future studies show less involved reconstructions, such as trapeziectomy alone, are as effective as more complicated ligament reconstructions with tendon interposition, many patients may benefit from this less complex surgery. This trial would increase clinician and patient awareness and confidence in effective treatment regimens. This 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 a significant functional, health utility, and economic advantage to surgically treating advanced basal joint arthritis of the thumb with one of the popularized procedures currently in practice.


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.


NCT ID:

NCT01376024


Primary Contact:

Principal Investigator
Melvin P Rosenwasser, MD
Columbia University

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


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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