PRCT: Comparing Two Procedures for Ulno-Carpal Abutment Syndrome. (UAS)

This study has been terminated.
(Inability to recruit required number of subjects.)
Sponsor:
Information provided by:
Simon Fraser Orthopaedic Fund
ClinicalTrials.gov Identifier:
NCT00564980
First received: November 27, 2007
Last updated: February 4, 2010
Last verified: February 2010
  Purpose

The purpose of this study is to evaluate two different currently accepted surgical treatments for UAS (ulnocarpal abutment syndrome).

The hypothesis is that ulnar shortening osteotomy procedure will be associated with longer surgical time and increased complication rate when compared to the wafer procedure. It is unclear as to whether there will be a difference in functional outcome between the two groups.


Condition Intervention
Joint Disease
Procedure: Wafer Procedure
Procedure: Ulnar shortening osteotomy

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 TFCC Debridement and Wafer Procedure With TFCC Debridement and Ulnar Shortening Osteotomy for Ulno-Carpal Abutment Syndrome. (UAS Study)

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 ]

Enrollment: 3
Study Start Date: July 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Wafer Procedure
Procedure: Wafer Procedure
A dorsal approach to the distal ulna is used dividing the extensor retinaculum between the 5th and 6th compartments. The ulnar head is exposed through a transverse capsulotomy. Cartilage and bone are resected to result in slight negative ulnar variance based on the preoperative pronated grip view. The ulnar styloid and TFCC attachments are preserved. The dorsal capsule and retinaculum are repaired in separate layers.
Active Comparator: 2
Ulnar shortening osteotomy
Procedure: Ulnar shortening osteotomy
A longitudinal incision of approximately 8 cm is made at the distal third of the ulna along the ulnar border of the forearm. The interval between the flexor carpi ulnaris is used. The ulna is exposed at its distal third preserving the periosteum. Care is taken to protect the sensory branches of the lunar nerve. An oblique osteotomy is performed using a reciprocating saw, removing enough bone to result is slight negative ulnar variance. Fixation and compression at the osteotomy site is achieved using a 5 or 6 hole titanium LC-DCP plate.

Detailed Description:

Ulnocarpal abutment syndrome (UAS) (also known as ulnar impaction syndrome, ulnocarpal impingement,ulnar carpal loading) is a common cause of ulnar sided wrist pain.

UAS results from increased loading of the ulnocarpal articulation and is usually associated with a positive ulnar variance. The increased loading of the joint can lead to degeneration and perforation of the Triangular fibrocartilage (TFC). Chondromalacic changes develop on the opposing surfaces of the lunate and triquetrum distally and the ulnar head proximally. A disruption of the lunotriquetral ligament may following with ensuing LT arthritis.

Treatment of UAS involves decompression of the pressure and impingement, or abutment of the ulnocarpal articulation. Debridement of triangular fibrocartilage complex (TFCC) tears alone in the patient with UAS may have a failure rate of as much as 25% to 30%. Good results have been reported with combined arthroscopic TFCC debridement and distal ulnar resection. 69% excellent and 32% good results have been reported with an open limited distal ulnar resection in patients with a TFCC tear and positive ulnar variance. Similar results have been reported with both ulnar shortening osteotomy and open wafer distal ulnar resections in the UAS patient. Because these treatment choices appear to yield similar relief of symptoms, determination of the optimal treatment protocol remains a point of debate.

The literature contains retrospective data comparing open wafer procedure with ulnar shortening osteotomies for the treatment of UAS. Likewise, the literature comparing arthroscopic wafer and ulnar shortening osteotomy is retrospective. However, there are, to date, no randomized prospective clinical trials comparing these types of surgery. Both types of surgery are widely accepted and the optimal treatment remains under debate. It is unclear how the techniques compare in terms of efficacy of elimination of symptoms of UAS and also in terms of relative complication rate.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • persistent ulnar-sided wrist pain of a minimum of 6 months duration despite conservative management
  • a positive ulnocarpal stress test
  • neutral or positive ulnar variance as measured from a standard posteroanterior radiograph of the wrist
  • central TFCC perforation or lunate chondral damage consistent with UAS based on arthroscopic evaluation
  • arthroscopically debrided TFCC tear

Exclusion Criteria:

  • absence of a TFCC tear or lunate chondral damage
  • repairable TFCC tear
  • severe ulnocarpal arthrosis
  • pre-operative diagnosis of clinically symptomatic scapholunate ligament (SL), lunotriquetral ligament (LT), or distal radioulnar joint (DRUJ) instability
  • previous forearm or wrist fracture
  • history of inflammatory arthritis
  • presence of other wrist pathology
  • a requirement for concomitant surgery for an unrelated condition
  • skeletal maturity
  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: NCT00564980

Locations
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Eagle Ridge Hospital
Port Moody, British Columbia, Canada, V3H 3W9
Sponsors and Collaborators
Simon Fraser Orthopaedic Fund
Investigators
Principal Investigator: Bertrand H Perey, MD Royal Columbian Hospital, Eagle Ridge Hospital
  More Information

Publications:
Milch H. Cuff resection of the ulna for malunited colles' fracture. JBJS (AM): 1941;23:311-313

Responsible Party: Bertrand Perey, MD, Simon Fraser Orthopaedic Fund
ClinicalTrials.gov Identifier: NCT00564980     History of Changes
Other Study ID Numbers: 2006-061
Study First Received: November 27, 2007
Last Updated: February 4, 2010
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 October 20, 2014