PRCT: Comparing Two Procedures for Ulno-Carpal Abutment Syndrome. (UAS)
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|ClinicalTrials.gov Identifier: NCT00564980|
Recruitment Status : Terminated (Inability to recruit required number of subjects.)
First Posted : November 29, 2007
Last Update Posted : May 21, 2015
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 or disease||Intervention/treatment||Phase|
|Joint Disease||Procedure: Wafer Procedure Procedure: Ulnar shortening osteotomy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Active Comparator: 1
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.
- 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. ]
- Wrist range of motion, grip strength, radiographs and pain Visual Analog Scale [ Time Frame: Baseline, 6 weeks, 3,6 and 12 months. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564980
|Canada, British Columbia|
|Royal Columbian Hospital|
|New Westminster, British Columbia, Canada, V3L 3W7|
|Eagle Ridge Hospital|
|Port Moody, British Columbia, Canada, V3H 3W9|
|Principal Investigator:||Bertrand H Perey, MD||Royal Columbian Hospital, Eagle Ridge Hospital|