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

Primary Purpose

Osteoarthritis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Flexor carpi radialis
Abductor pollicis longus
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Flexor carpi radialis

    Abductor pollicis longus

    Arm Description

    These patients will have their trapeziectomy with ligament reconstruction and tendon interposition using the flexor carpi radialis tendon.

    These patients will have their trapeziectomy with ligament reconstruction and tendon interposition using the abductor pollicis longus tendon.

    Outcomes

    Primary Outcome Measures

    Disabilities of arm shoulder and hand questionnaire
    questionnaire

    Secondary Outcome Measures

    thumb range of motion
    grip strength
    jamar dynamometer

    Full Information

    First Posted
    September 1, 2015
    Last Updated
    August 3, 2016
    Sponsor
    Nova Scotia Health Authority
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02540057
    Brief Title
    FCR or APL in LRTI - A Single Surgeon Randomized Controlled Trial
    Official Title
    Flexor Carpi Radialis or Abductor Pollicis Longus in Ligament Reconstruction and Tendon Interposition - A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Abandoned following local ethics review.
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nova Scotia Health Authority

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Flexor carpi radialis
    Arm Type
    Active Comparator
    Arm Description
    These patients will have their trapeziectomy with ligament reconstruction and tendon interposition using the flexor carpi radialis tendon.
    Arm Title
    Abductor pollicis longus
    Arm Type
    Active Comparator
    Arm Description
    These patients will have their trapeziectomy with ligament reconstruction and tendon interposition using the abductor pollicis longus tendon.
    Intervention Type
    Procedure
    Intervention Name(s)
    Flexor carpi radialis
    Intervention Description
    Ligament reconstruction with tendon interposition completed using the flexor carpi radialis tendon
    Intervention Type
    Procedure
    Intervention Name(s)
    Abductor pollicis longus
    Intervention Description
    Ligament reconstruction with tendon interposition completed using the abductor pollicis longus tendon
    Primary Outcome Measure Information:
    Title
    Disabilities of arm shoulder and hand questionnaire
    Description
    questionnaire
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    thumb range of motion
    Time Frame
    5 years
    Title
    grip strength
    Description
    jamar dynamometer
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joseph P Corkum, MD,BEng
    Organizational Affiliation
    Nova Scotia Health Authority
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24928359
    Citation
    Vermeulen GM, Spekreijse KR, Slijper H, Feitz R, Hovius SE, Selles RW. Comparison of arthroplasties with or without bone tunnel creation for thumb basal joint arthritis: a randomized controlled trial. J Hand Surg Am. 2014 Sep;39(9):1692-8. doi: 10.1016/j.jhsa.2014.04.044. Epub 2014 Jun 10.
    Results Reference
    background
    PubMed Identifier
    25702783
    Citation
    Wajon A, Vinycomb T, Carr E, Edmunds I, Ada L. Surgery for thumb (trapeziometacarpal joint) osteoarthritis. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD004631. doi: 10.1002/14651858.CD004631.pub4.
    Results Reference
    result

    Learn more about this trial

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

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