Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Melvin P Rosenwasser, MD|
|Principal Investigator Affiliation||Columbia University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Osteoarthrosis of the Carpometacarpal Joint of the Thumb|
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.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.