FCR or APL in LRTI - A Single Surgeon Randomized Controlled Trial

August 3, 2016 updated by: David Tang, Nova Scotia Health Authority

Flexor Carpi Radialis or Abductor Pollicis Longus in Ligament Reconstruction and Tendon Interposition - A Randomized Controlled Trial

We are investigating the use of the flexor carpi radialis and abductor pollicis longus tendons in the use of trapeziectomy and ligament reconstruction with tendon interposition. Previous studies have shown clinical equipoise, and we plan to do a randomized controlled trial to further assess.

Study Overview

Detailed Description

Trapeziometacarpal osteoarthritis (TMC OA) is a great societal burden. Its prevalence has been reported as high as 36% in select populations, and is directly responsible for reduced work productivity and absenteeism in many cases. In 1949 Gervis originally described simply removing the offending bone, the trapezium, and trapeziectomy has since shown favorable outcomes. Many others have subsequently published similar clinical results with the same technique. However, it has been noted that with trapeziectomy alone there is the risk of metacarpal subsidence into the trapezial fossa over time, which may have an impact on patient outcomes. This observation was the impetus for the development of several more complex surgical interventions for TMC OA.

A recent Cochrane review investigated the literature available comparing seven surgical interventions for TMC OA. There were very few significant differences discovered, and they ultimately did not identify a single procedure as superior. The included studies however were noted as being of low quality, and the authors called for more robust trials with standardized outcome measures.

One of the more popular techniques reviewed is the trapeziectomy with ligament reconstruction and tendon interposition (LRTI). First described by Eaton and Littler, it has been met with widespread adoption, and has shown good results. It theoretically reconstructs the ligament responsible for maintaining the metacarpal's position, and also places a tendon interposed between the two bones (scaphoid and base of the first metacarpal) thus limiting its collapse. The most commonly used tendon for reconstruction of the volar beak ligament is the flexor carpi radialis (FCR), but recent reports have also advocated for use of the abductor pollicis longus (APL). The APL tendon already inserts onto the base of the first metacarpal, obviating the need for creating a bone tunnel, which is required when using the FCR. It can also be harvested without the need for additional incisions. Only one study has directly compared the two procedures, and the results were similar for both.

Based on the available literature, trapeziectomy with LRTI may confer minor advantages to simple trapeziectomy. Currently, surgeons at our institution unanimously prefer the LRTI procedure, however there is discord on which tendon is best suited for the reconstruction. We hypothesize that complications will be similar between the two procedures, but DASH scores and operative time will be significantly decreased when using the APL tendon for reconstruction.

Study Type

Interventional

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with any grade of trapeziometacarpal joint osteoarthritis undergoing surgical correction with trapeziectomy and ligament reconstruction with tendon interposition

Exclusion Criteria:

  • previous wrist surgery, inflammatory arthritis

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Flexor carpi radialis
These patients will have their trapeziectomy with ligament reconstruction and tendon interposition using the flexor carpi radialis tendon.
Ligament reconstruction with tendon interposition completed using the flexor carpi radialis tendon
Active Comparator: Abductor pollicis longus
These patients will have their trapeziectomy with ligament reconstruction and tendon interposition using the abductor pollicis longus tendon.
Ligament reconstruction with tendon interposition completed using the abductor pollicis longus tendon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disabilities of arm shoulder and hand questionnaire
Time Frame: 5 years
questionnaire
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
thumb range of motion
Time Frame: 5 years
5 years
grip strength
Time Frame: 5 years
jamar dynamometer
5 years

Collaborators and Investigators

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

Investigators

  • Study Director: Joseph P Corkum, MD,BEng, Nova Scotia Health Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

August 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

September 1, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 3, 2015

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • FCRAPLRCT

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.

Clinical Trials on Osteoarthritis

Clinical Trials on Flexor carpi radialis

3
Subscribe