PRCT: Ligament Reconstruction & Tendon Interposition With a Joint Spacer for Trapeziometacarpal OA (TMC/PyroDisk)

Fraser Orthopaedic Research Society

Status

Terminated

Conditions

Joint Disease

Treatments

Procedure: LRTI

Procedure: Ascension PyroDisk

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00671333

2006-060

Details and patient eligibility

About

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.

Full description

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.

Enrollment

82 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

isolated trapeziometacarpal osteoarthritis
duration of symptoms of at least six months
failure to respond to non-operative management
age 50 or older
less than 30 degrees of ipsilateral MCP hyperextension
British Columbian resident living in the Lower Mainland and available for protocol follow-up

Exclusion criteria