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OsteoarthritisNCT02540057

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

A study testing Flexor carpi radialis and Abductor pollicis longus in people with Osteoarthritis, run by Nova Scotia Health Authority.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Osteoarthritis
What is being tested?
Flexor carpi radialis and Abductor pollicis longus
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Aug 2016to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • previous wrist surgery, inflammatory arthritis

About this study

Official title: 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.

Read the 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.

Conditions
Osteoarthritis
Being tested
Flexor carpi radialis, Abductor pollicis longus
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flexor carpi radialisProcedure or surgery

    Ligament reconstruction with tendon interposition completed using the flexor carpi radialis tendon

  • Abductor pollicis longusProcedure or surgery

    Ligament reconstruction with tendon interposition completed using the abductor pollicis longus tendon

Study groups in NCT02540057
Study groupRoleWhat they receive
Flexor carpi radialisActive comparatorThese patients will have their trapeziectomy with ligament reconstruction and tendon interposition using the flexor carpi radialis tendon.
Receives: Procedure: Flexor carpi radialis
Abductor pollicis longusActive comparatorThese patients will have their trapeziectomy with ligament reconstruction and tendon interposition using the abductor pollicis longus tendon.
Receives: Procedure: Abductor pollicis longus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disabilities of arm shoulder and hand questionnaire

    questionnaire

    Measured: 5 years

Secondary outcomes (2)
  1. thumb range of motion

    Measured: 5 years

  2. grip strength

    jamar dynamometer

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2015 (estimated)
  2. Study startAug 2016
  3. Primary completionAug 2016
  4. Study completionAug 2016

Why it stopped: Abandoned following local ethics review.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02540057
Sponsor's protocol ID
FCRAPLRCT
Status last verified
Aug 2016
First submitted
1 Sep 2015
Last updated
5 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24928359
  • 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.

    PubMed 25702783

Questions about this trial

What is this clinical trial studying?

A study testing Flexor carpi radialis and Abductor pollicis longus in people with Osteoarthritis, run by Nova Scotia Health Authority.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disabilities of arm shoulder and hand questionnaire (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02540057, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016.

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