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

J&M Shuler

Status: Completed

Conditions: Thumb Carpometacarpal Arthritis

Treatments: Procedure: Ligament reconstruction with suture fixation system; Procedure: Ligament Reconstruction with Tendon Interposition (LRTI)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01121874

CMC-101

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 3 patient groups

LRTI

Active Comparator group

Description:

These patients will undergo ligament reconstruction with tendon interposition (LRTI) surgery. They will serve as a control group, against which to compare the investigational surgical technique.

Treatment:

Procedure: Ligament Reconstruction with Tendon Interposition (LRTI)

Suture fixation system

Experimental group

Description:

CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system.

Treatment:

Procedure: Ligament reconstruction with suture fixation system

Procedure: Ligament reconstruction with suture fixation system

Suture fixation system + 2 week immobilization

Experimental group

Description:

CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system, and with a decreased immobilization time from 6 to 2 weeks post-surgery.

Treatment:

Procedure: Ligament reconstruction with suture fixation system

Procedure: Ligament reconstruction with suture fixation system