A Randomized Prospective Study Comparing Ligament Reconstruction and Tendon Interposition (LRTI) With a Joint Spacer (Ascension PyroDisk) for Trapeziometacarpal Osteoarthritis.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 82
- Locations
- 4
- Primary Endpoint
- Patient Rated Wrist Evaluation (PRWE) at baseline, 6 weeks, 3, 6 and 12 months post-operatively.
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •previous surgery for TMC arthritis
- •other significant ipsilateral wrist or hand pathology
- •a history of inflammatory arthropathy
- •a requirement for concommitant surgery for another condition
- •any previous hand or wrist fracture
Arms & Interventions
1
(LRTI) Ligament reconstruction and tendon interposition
Intervention: LRTI (Procedure)
2
Ascension PyroDisk
Intervention: Ascension PyroDisk (Procedure)
Outcomes
Primary Outcomes
Patient Rated Wrist Evaluation (PRWE) at baseline, 6 weeks, 3, 6 and 12 months post-operatively.
Time Frame: Subjects are followed for 12 months post-op.
Secondary Outcomes
- Wrist range of motion, grip strength, radiographs, and pain Visual Analog Scale.(Baseline, 6 weeks, 3,6 and 12 months.)