PRCT: Comparing Two Procedures for Ulno-Carpal Abutment Syndrome. (UAS)
Primary Purpose
Joint Disease
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Wafer Procedure
Ulnar shortening osteotomy
Sponsored by
About this trial
This is an interventional treatment trial for Joint Disease focused on measuring Randomized, Prospective, Procedure / Surgery
Eligibility 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
Sites / Locations
- Royal Columbian Hospital
- Eagle Ridge Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Wafer Procedure
Ulnar shortening osteotomy
Outcomes
Primary Outcome Measures
Patient Rated Wrist Evaluation (PRWE) at baseline, 6 weeks, 3, 6 and 12 months post-operatively.
Secondary Outcome Measures
Wrist range of motion, grip strength, radiographs and pain Visual Analog Scale
Full Information
NCT ID
NCT00564980
First Posted
November 27, 2007
Last Updated
May 19, 2015
Sponsor
Fraser Orthopaedic Research Society
1. Study Identification
Unique Protocol Identification Number
NCT00564980
Brief Title
PRCT: Comparing Two Procedures for Ulno-Carpal Abutment Syndrome.
Acronym
UAS
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 Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Inability to recruit required number of subjects.
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fraser Orthopaedic Research Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Disease
Keywords
Randomized, Prospective, Procedure / Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Wafer Procedure
Arm Title
2
Arm Type
Active Comparator
Arm Description
Ulnar shortening osteotomy
Intervention Type
Procedure
Intervention Name(s)
Wafer Procedure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ulnar shortening osteotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Wrist range of motion, grip strength, radiographs and pain Visual Analog Scale
Time Frame
Baseline, 6 weeks, 3,6 and 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand H Perey, MD
Organizational Affiliation
Royal Columbian Hospital, Eagle Ridge Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
Facility Name
Eagle Ridge Hospital
City
Port Moody
State/Province
British Columbia
ZIP/Postal Code
V3H 3W9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
7119397
Citation
Palmer AK, Glisson RR, Werner FW. Ulnar variance determination. J Hand Surg Am. 1982 Jul;7(4):376-9. doi: 10.1016/s0363-5023(82)80147-0. No abstract available.
Results Reference
background
PubMed Identifier
1880164
Citation
Friedman SL, Palmer AK. The ulnar impaction syndrome. Hand Clin. 1991 May;7(2):295-310.
Results Reference
background
PubMed Identifier
10722828
Citation
Tomaino MM. The importance of the pronated grip x-ray view in evaluating ulnar variance. J Hand Surg Am. 2000 Mar;25(2):352-7. doi: 10.1053/jhsu.2000.jhsu25a0352.
Results Reference
background
PubMed Identifier
9260628
Citation
Hulsizer D, Weiss AP, Akelman E. Ulna-shortening osteotomy after failed arthroscopic debridement of the triangular fibrocartilage complex. J Hand Surg Am. 1997 Jul;22(4):694-8. doi: 10.1016/S0363-5023(97)80130-X.
Results Reference
background
PubMed Identifier
9763270
Citation
Minami A, Kato H. Ulnar shortening for triangular fibrocartilage complex tears associated with ulnar positive variance. J Hand Surg Am. 1998 Sep;23(5):904-8. doi: 10.1016/S0363-5023(98)80171-8.
Results Reference
background
PubMed Identifier
1629557
Citation
Feldon P, Terrono AL, Belsky MR. Wafer distal ulna resection for triangular fibrocartilage tears and/or ulna impaction syndrome. J Hand Surg Am. 1992 Jul;17(4):731-7. doi: 10.1016/0363-5023(92)90325-j.
Results Reference
background
PubMed Identifier
11721249
Citation
Tomaino MM, Weiser RW. Combined arthroscopic TFCC debridement and wafer resection of the distal ulna in wrists with triangular fibrocartilage complex tears and positive ulnar variance. J Hand Surg Am. 2001 Nov;26(6):1047-52. doi: 10.1053/jhsu.2001.28757.
Results Reference
background
PubMed Identifier
10642473
Citation
Constantine KJ, Tomaino MM, Herndon JH, Sotereanos DG. Comparison of ulnar shortening osteotomy and the wafer resection procedure as treatment for ulnar impaction syndrome. J Hand Surg Am. 2000 Jan;25(1):55-60. doi: 10.1053/jhsu.2000.jhsu025a0055.
Results Reference
background
PubMed Identifier
15067279
Citation
Bernstein MA, Nagle DJ, Martinez A, Stogin JM Jr, Wiedrich TA. A comparison of combined arthroscopic triangular fibrocartilage complex debridement and arthroscopic wafer distal ulna resection versus arthroscopic triangular fibrocartilage complex debridement and ulnar shortening osteotomy for ulnocarpal abutment syndrome. Arthroscopy. 2004 Apr;20(4):392-401. doi: 10.1016/j.arthro.2004.01.013.
Results Reference
background
Citation
Milch H. Cuff resection of the ulna for malunited colles' fracture. JBJS (AM): 1941;23:311-313
Results Reference
background
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PRCT: Comparing Two Procedures for Ulno-Carpal Abutment Syndrome.
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