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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Simon Fraser Orthopaedic Fund
Sponsor:
Information provided by (Responsible Party):
Simon Fraser Orthopaedic Fund
ClinicalTrials.gov Identifier:
NCT00671333
First received: May 1, 2008
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Joint Disease
Procedure: LRTI
Procedure: Ascension PyroDisk

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Prospective Study Comparing Ligament Reconstruction and Tendon Interposition (LRTI) With a Joint Spacer (Ascension PyroDisk) for Trapeziometacarpal Osteoarthritis.

Resource links provided by NLM:


Further study details as provided by Simon Fraser Orthopaedic Fund:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wrist range of motion, grip strength, radiographs, and pain Visual Analog Scale. [ Time Frame: Baseline, 6 weeks, 3,6 and 12 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: April 2008
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
(LRTI) Ligament reconstruction and tendon interposition
Procedure: LRTI
Dorsal radial incision, capsulotomy between EPB and APL protecting the radial artery, trapeziectomy using a cruciate osteotomy and rongeurs, creation of a metacarpal base bone tunnel using a high speed burr, harvesting of entire FCR tendon through two transverse volar incisions, ligament reconstruction and tendon interposition using "Fibre Wire" suture. Closure of capsule with Vicryl. Closure of skin with running Prolene suture.
Active Comparator: 2
Ascension PyroDisk
Procedure: Ascension PyroDisk
Dorsal radial incision, capsulotomy between EPB and APL protecting the radial artery, distal 2 mm of trapezium and dorsal cortex of both trapezium and metacarpal removed using osteotomes/rongeurs. A hole is drilled through the trapezium from dorsal to resected distal surface, and a second hole is drilled through the first metacarpal from the resected base to the dorsal surface. A slip of FCR is harvested. The tendon is woven through the trapezium, the central hole in the device, and the metacarpal tunnel then sutured back onto itself. Closure of capsule with Vicryl. Closure of skin with running Prolene suture.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671333

Contacts
Contact: Mauri L Zomar 604-520-4855 mauri.zomar@fraserhealth.ca

Locations
Canada, British Columbia
Royal Columbian Hospital Recruiting
New Westminster, British Columbia, Canada, V3L 3W7
Contact: Mauri L Zomar    604-520-4855    mauri.zomar@fraserhealth.ca   
Principal Investigator: Bertrand H Perey         
Eagle Ridge Hospital Recruiting
Port Moody, British Columbia, Canada, V3H 3W9
Contact: Mauri L. Zomar    604-520-4855    mauri.zomar@fraserhealth.ca   
Principal Investigator: Bertrand H Perey, MD         
Sponsors and Collaborators
Simon Fraser Orthopaedic Fund
Investigators
Principal Investigator: Bertrand H Perey, MD Royal Columbian Hospital, Eagle Ridge Hospital
  More Information

Publications:

Responsible Party: Simon Fraser Orthopaedic Fund
ClinicalTrials.gov Identifier: NCT00671333     History of Changes
Other Study ID Numbers: 2006-060
Study First Received: May 1, 2008
Last Updated: November 18, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Simon Fraser Orthopaedic Fund:
Randomized
Prospective
Procedure / Surgery

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 29, 2014