NCT00564980

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

2.5 years

First QC Date

November 27, 2007

Last Update Submit

May 19, 2015

Conditions

Joint Disease

Keywords

RandomizedProspectiveProcedure / Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Wrist range of motion, grip strength, radiographs and pain Visual Analog Scale

    Baseline, 6 weeks, 3,6 and 12 months.

Study Arms (2)

1

ACTIVE COMPARATOR

Wafer Procedure

Procedure: Wafer Procedure

2

ACTIVE COMPARATOR

Ulnar shortening osteotomy

Procedure: Ulnar shortening osteotomy

Interventions

Wafer ProcedurePROCEDURE

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.

1
Ulnar shortening osteotomyPROCEDURE

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.

2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Eagle Ridge Hospital

Port Moody, British Columbia, V3H 3W9, Canada

Location

Related Publications (10)

  • 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.

    PMID: 7119397BACKGROUND

  • Friedman SL, Palmer AK. The ulnar impaction syndrome. Hand Clin. 1991 May;7(2):295-310.

    PMID: 1880164BACKGROUND

  • 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.

    PMID: 10722828BACKGROUND

  • 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.

    PMID: 9260628BACKGROUND

  • 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.

    PMID: 9763270BACKGROUND

  • 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.

    PMID: 1629557BACKGROUND

  • 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.

    PMID: 11721249BACKGROUND

  • 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.

    PMID: 10642473BACKGROUND

  • 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.

    PMID: 15067279BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

  • Bertrand H Perey, MD

    Royal Columbian Hospital, Eagle Ridge Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2007

First Posted

November 29, 2007

Study Start

July 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations

CA(2)