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Withdrawn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
About this trial
This is an interventional treatment trial for Osteoarthritis
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
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
NCT ID
NCT02540057
First Posted
September 1, 2015
Last Updated
August 3, 2016
Sponsor
Nova Scotia Health Authority
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Withdrawn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
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FCR or APL in LRTI - A Single Surgeon Randomized Controlled Trial
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