Suture Fixation System Versus Tendonous Reconstruction in Carpometacarpal (CMC) Arthroplasty



Status:Completed
Conditions:Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:8/17/2018
Start Date:April 12, 2010
End Date:July 25, 2012

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Suture Fixation System Versus Tendonous Reconstruction in Thumb Carpometacarpal Arthroplasty: a Randomized Controlled Trial

Thumb carpometacarpal (CMC) arthritis affect 1 in 4 females and 1 in 12 males. Patients who
fail to respond to conservative treatment may benefit from surgery; however, controversy
exists over the most effective surgical technique. A popular technique, ligament
reconstruction with tendon interposition (LRTI) involves a trapeziectomy, followed by
reconstruction of the palmar oblique ligament using a harvested flexor tendon from the wrist.

We believe that use of a suture fixation system to reconstruct the palmar oblique ligament,
instead of harvesting a wrist tendon, may provide a superior repair. The objective of this
study is to compare functional outcome measurements among patients who receive CMC
arthroplasty using a suture fixation system (investigational group) to those who receive LRTI
surgery (control group). We hypothesize that patients in the investigational group will
demonstrate superior functionality, compared to patients in the control group.


Inclusion Criteria:

- Male or female patients aged >18.

- Eaton Stage III or IV CMC arthritis

- Failure to respond to conservative treatment

Exclusion Criteria:

- Previous surgical interventions on that thumb

- Upper extremity neurological dysfunction

- Inability to effectively communicate with the research staff, due to hearing
impairment, cognitive impairment, or a language barrier

- Unwilling or unable to provide written informed consent
We found this trial at
1
site
Athens, Georgia 30606
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from
Athens, GA
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