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

NCT01121874 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2018-08-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • J&M Shuler

    lead INDUSTRY

Principal Investigators

  • Michael Shuler, MD · Athens Orthopedic Clinic, PA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-12
Primary Completion
2012-05-21
Completion
2012-07-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01121874 on ClinicalTrials.gov