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

Completed · Not applicable

Conditions studied: Thumb Carpometacarpal Arthritis

In brief

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.

Key facts

Study ID

NCT01121874

Run by

J&M Shuler

People needed

53

Starts

2010-04-12

Expected to finish

2012-07-25

Last updated by the study team

2018-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients aged >18.
• Eaton Stage III or IV CMC arthritis
• Failure to respond to conservative treatment

You may not qualify if…

• 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

Where it is running

• Athens Orthopedic Clinic — Athens, Georgia, United States

Full record on ClinicalTrials.gov

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