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

This study is currently recruiting participants.
Verified January 2013 by J&M Shuler
Sponsor:
Information provided by (Responsible Party):
Michael Shuler, J&M Shuler
ClinicalTrials.gov Identifier:
NCT01121874
First received: April 9, 2010
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Thumb Carpometacarpal Arthritis
 Procedure: Ligament reconstruction with suture fixation system
Procedure: Ligament Reconstruction with Tendon Interposition (LRTI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Suture Fixation System Versus Tendonous Reconstruction in Thumb Carpometacarpal Arthroplasty: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by J&M Shuler:

Primary Outcome Measures:
  • Overall functionality [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).

  • Overall Functionality [ Time Frame: 6 wks ] [ Designated as safety issue: No ]
  • Overall Functionality [ Time Frame: 3 mos ] [ Designated as safety issue: No ]
  • Overall Functionality [ Time Frame: 6 mos ] [ Designated as safety issue: No ]
  • Overall Functionality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall Functionality [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analog pain scale [ Time Frame: Baseline, 2 wks, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos ] [ Designated as safety issue: No ]
    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.

  • Strength measures [ Time Frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos ] [ Designated as safety issue: No ]
    Strength will be assessed via key and tip pinch strength and grip strength, using a dynamometer

  • Range of motion [ Time Frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos ] [ Designated as safety issue: No ]
    Range of motion (ROM) will be assessed via radial and palmar abduction (degrees) and opposition (cm).

  • Operative time [ Time Frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos ] [ Designated as safety issue: No ]
    Operative time in minutes

  • Scaphometacarpal distance [ Time Frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos ] [ Designated as safety issue: No ]
    Distance between the distal pole of the scaphoid and the proximal aticular surface of the metacarpal. Taken in stressed and relaxed views


Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
Experimental: Suture fixation system
CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system.
 Procedure: Ligament reconstruction with suture fixation system
CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system
Other Name: Arthrex Mini TightRope

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121874

Contacts
Contact: Michael Shuler, MD 706-433-4031 jandmshuler@gmail.com

Locations
United States, Georgia
Athens Orthopedic Clinic Recruiting
Athens, Georgia, United States, 30606
Principal Investigator: Michael Shuler, MD            
Sponsors and Collaborators
J&M Shuler
Investigators
Principal Investigator: Michael Shuler, MD Athens Orthopedic Clinic, PA
  More Information

No publications provided

Responsible Party: Michael Shuler, Hand and Upper Extremity Specialist, J&M Shuler
ClinicalTrials.gov Identifier: NCT01121874     History of Changes
Other Study ID Numbers: CMC-101
Study First Received: April 9, 2010
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by J&M Shuler:
CMC arthritis
thumb carpometacarpal arthritis
basal joint arthritis
thumb CMC arthritis

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 19, 2013