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.

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 Title

Basal Joint Arthritis Prospective

Official Title

Multicenter Prospective Study on Basal Joint Arthritis of the Thumb

Brief Summary

The study hypothesizes that there exist effective non-operative and operative treatments for<br /> certain patient populations with basal joint arthritis of the thumb. There also exists a<br /> functionally superior, cost effective, and low risk non-operative or minimally invasive<br /> operative treatment regime to alleviate pain and slow the progression of disease in those<br /> with less advanced disease. Likewise, there is significant functional, health utility, and<br /> economic advantage to surgically treating advanced basal joint arthritis with one of the<br /> popularized procedures currently in practice.<br /><br /> Arthritis at the base of the thumb is a common condition associated with considerable patient<br /> discomfort. Many non-operative and operative treatments have been described, but few<br /> prospective studies involving multiple centers comparing these treatments have been done. By<br /> following patients from the start of their arthritis treatment and assessing their progress<br /> at certain time points using questionnaires and radiographs the investigators believe patient<br /> outcomes and satisfaction can improve. This study will include patients who are treated<br /> non-operatively and operatively and will not change patients' standard of care. By<br /> establishing standardized outcome measures and collecting data prospectively from the time of<br /> initial presentation through all treatment interventions it will be possible to directly<br /> compare treatments during the conservative and operative care of basal joint arthritis of the<br /> thumb. This multi-center study will identify those specific procedures or conservative<br /> treatments that have the greatest potential to be studied in subsequent focused and<br /> well-designed randomized control trials.

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. 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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.