NCT01121874

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: J&M Shuler · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Thumb Carpometacarpal Arthritis

Interventions

Type	Name	Description
PROCEDURE	Ligament reconstruction with suture fixation system	CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system
PROCEDURE	Ligament Reconstruction with Tendon Interposition (LRTI)	commonly performed CMC arthroplasty technique, consisting of a trapeziectomy, followed by palmar oblique ligament reconstruction using a harvested flexor tendon from the wrist.
PROCEDURE	Ligament reconstruction with suture fixation system	CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system, with a decreased period of immobilization from 6 weeks to 2 weeks.

Timeline

• Start date: 2010-04-12
• Primary completion: 2012-05-21
• Completion: 2012-07-25
• First posted: 2010-05-12
• Last updated: 2018-08-15

Locations

1 site across 1 country: United States