Basal Joint Arthritis Prospective (BJAM)
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|ClinicalTrials.gov Identifier: NCT01376024|
Recruitment Status : Recruiting
First Posted : June 20, 2011
Last Update Posted : March 12, 2015
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.
|Condition or disease|
|Osteoarthrosis of the Carpometacarpal Joint of the Thumb|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Multicenter Prospective Study on Basal Joint Arthritis of the Thumb|
|Study Start Date :||March 2007|
|Estimated Primary Completion Date :||August 2025|
|Estimated Study Completion Date :||August 2025|
- Pain Relief [ Time Frame: Initially, up to 1 year ]Subject may have annual assessments after the 1st year.
- Functional strength-dexterity [ Time Frame: Initially, up to 1 year ]Subject may have annual assessments after the 1st year.
- Cost effectiveness [ Time Frame: Initially, up to 1 year ]Subject may have annual assessments after the 1st year.
- Patient satisfaction [ Time Frame: Initially, up to 1 year ]Subject may have annual assessments after the 1st year.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376024
|Contact: John W Karl, MD, MPHfirstname.lastname@example.org|
|United States, New York|
|Columbia University/NY Presbyterian Hospital||Recruiting|
|New York, New York, United States, 10032|
|Principal Investigator:||Melvin P Rosenwasser, MD||Columbia University|