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

August 14, 2018 updated by: Michael Shuler, J&M Shuler

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Athens, Georgia, United States, 30606
        • Athens Orthopedic Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: LRTI
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.
commonly performed CMC arthroplasty technique, consisting of a trapeziectomy, followed by palmar oblique ligament reconstruction using a harvested flexor tendon from the wrist.
EXPERIMENTAL: Suture fixation system
CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system.
CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system
Other Names:
  • Arthrex Mini TightRope
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.
Other Names:
  • Arthrex Mini TightRope
EXPERIMENTAL: Suture fixation system + 2 week immobilization
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.
CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system
Other Names:
  • Arthrex Mini TightRope
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.
Other Names:
  • Arthrex Mini TightRope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall functionality
Time Frame: Baseline
Functionality will be assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, which assesses functionality of the upper extremity, and Short Form 36 (SF-36) health outcomes assessment, which quantifies global functionality (not specific to the upper extremity).
Baseline
Overall Functionality
Time Frame: 6 wks
6 wks
Overall Functionality
Time Frame: 3 mos
3 mos
Overall Functionality
Time Frame: 6 mos
6 mos
Overall Functionality
Time Frame: 12 months
12 months
Overall Functionality
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analog pain scale
Time Frame: Baseline, 2 wks, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Pain will be assessed using the visual analog pain scale, which asks the patient to rate their pain on a scale from 1 to 10.
Baseline, 2 wks, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Strength measures
Time Frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Strength will be assessed via key and tip pinch strength and grip strength, using a dynamometer
Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Range of motion
Time Frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Range of motion (ROM) will be assessed via radial and palmar abduction (degrees) and opposition (cm).
Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Operative time
Time Frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Operative time in minutes
Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Scaphometacarpal distance
Time Frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Distance between the distal pole of the scaphoid and the proximal aticular surface of the metacarpal. Taken in stressed and relaxed views
Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 12, 2010

Primary Completion (ACTUAL)

May 21, 2012

Study Completion (ACTUAL)

July 25, 2012

Study Registration Dates

First Submitted

April 9, 2010

First Submitted That Met QC Criteria

May 11, 2010

First Posted (ESTIMATE)

May 12, 2010

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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