Joint Disease Clinical Trial
Official title:
A Randomized Prospective Study Comparing Ligament Reconstruction and Tendon Interposition (LRTI) With a Joint Spacer (Ascension PyroDisk) for Trapeziometacarpal Osteoarthritis.
The purpose of this study is to compare the effectiveness of two types of operative treatment
in terms of resolving symptoms, improving function and also with respect to x-ray outcomes.
The hypothesis is that insertion of a spacer will provide similar symptomatic relief, but
improved long term gains in key and tripod pinch strength when compared to LRTI.
Trapeziometacarpal (TMC) arthritis is a common condition, which occurs when the cartilage
(tissue) covering the bones at the joint at the base of the thumb wear away. This condition
occurs in 10% of women and 1% of men.
There is controversy regarding the best treatment of this condition and many surgical
techniques are in common use.
One of these involves removing the wrist bone (trapezium) at the base of the thumb and, using
a tendon from the forearm, reconstructing an important ligament, which contributes to the
stability of the thumb. This is known as a Ligament Reconstruction and Tendon Interposition
(LRTI).
A newer type of operation involves the insertion of a Ascension PyroDisk which is made from a
thick pyrocarbon layer encasing a graphite core with a small amount of tungsten. These
materials have been shown to be safe when implanted in the body. The PyroDisk is a disk
shaped design which has a curved surface designed to fit between the bony surfaces of the
trapezium and the metacarpal, reducing pain and allowing for full movement of the joint. It
contains a hole in the center through which a strip of tendon can be passed and helps hold
the disk in place.
This research study is designed to determine the effectiveness of the Ascension PyroDisk
spacer when compared to the LRTI procedure described above. The effectiveness of both of
these procedures will be determined by comparing range of motion, grip and pinch strength,
x-rays, function and return to work. It is important to compare both procedures, as it is not
known which procedure is the most effective.
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