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

Not Applicable

Terminated

• Conditions: Joint Disease
• Interventions: Procedure: Wafer Procedure; Procedure: Ulnar shortening osteotomy

• Registration Number: NCT00564980
• Lead Sponsor: Fraser Orthopaedic Research Society

Brief Summary

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.

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-11-27
• Study First Submitted QC: 2007-11-27
• Study First Posted: 2007-11-29
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Wafer Procedure	Wafer Procedure
2	Ulnar shortening osteotomy	Ulnar shortening osteotomy

Primary Outcome Measures

Name	Time	Method
Patient Rated Wrist Evaluation (PRWE) at baseline, 6 weeks, 3, 6 and 12 months post-operatively.	Subjects are followed for 12 months post-op.

Secondary Outcome Measures

Name	Time	Method
Wrist range of motion, grip strength, radiographs and pain Visual Analog Scale	Baseline, 6 weeks, 3,6 and 12 months.

Trial Locations

Locations (2)

Royal Columbian Hospital; 🇨🇦 New Westminster, British Columbia, Canada

Eagle Ridge Hospital; 🇨🇦 Port Moody, British Columbia, Canada