Osteoarthritis Clinical Trial
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.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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