Overview

This trial is active, not recruiting.

Condition thumb carpometacarpal arthritis
Treatments ligament reconstruction with suture fixation system, ligament reconstruction with tendon interposition (lrti)
Sponsor J&M Shuler
Start date April 2010
End date December 2016
Trial size 120 participants
Trial identifier NCT01121874, CMC-101

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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.
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)
CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system.
ligament reconstruction with suture fixation system Arthrex Mini TightRope
CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system
(Experimental)
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.
ligament reconstruction with suture fixation system 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.

Primary Outcomes

Measure
Overall functionality
time frame: Baseline
Overall Functionality
time frame: 6 wks
Overall Functionality
time frame: 3 mos
Overall Functionality
time frame: 6 mos
Overall Functionality
time frame: 12 months
Overall Functionality
time frame: 24 months

Secondary Outcomes

Measure
Analog pain scale
time frame: 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
Range of motion
time frame: 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
Scaphometacarpal distance
time frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Suture Fixation System Versus Tendonous Reconstruction in Thumb Carpometacarpal Arthroplasty: a Randomized Controlled Trial
Principal investigator Michael Shuler, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by J&M Shuler.