Joint Disease Clinical Trial
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)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02314702 -
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems
|
||
Completed |
NCT03272139 -
Interscalene Block Versus Superior Trunk Block
|
Phase 4 | |
Completed |
NCT03271151 -
Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty
|
Phase 4 | |
Completed |
NCT01407874 -
A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
|
Phase 2 | |
Completed |
NCT01256216 -
Signature Versus Computer Assisted Surgery Study
|
N/A | |
Completed |
NCT03337243 -
Effect of Implanting Allogenic Cytokines Derived From Human Amniotic Membrane (HAM) and Mesenchymal Stem Cells Derived From Human Umbilical Cord Wharton's Jelly (HUMCWJ) on Pain and Functioning of Knee Osteoarthritis
|
N/A | |
Active, not recruiting |
NCT03294408 -
Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model
|
N/A | |
Withdrawn |
NCT02668211 -
Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components
|
N/A | |
Active, not recruiting |
NCT02239783 -
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems
|
||
Terminated |
NCT00698347 -
A Clinical Investigation of the M2a-Magnumâ„¢ Hip System
|
N/A | |
Completed |
NCT00223353 -
Quantitative Gait Analysis for Clinical Decision Making
|
N/A | |
Recruiting |
NCT04037735 -
RSA-RCT: Attune S+ TKA Versus Sigma TKA
|
N/A | |
Terminated |
NCT03575975 -
3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Arthroplasty
|
||
Completed |
NCT03894514 -
Multi-variable Prediction Model of Total Knee Replacement Outcome
|
||
Completed |
NCT02865447 -
Evaluation of Bone Mineral Density Changes After Total Hip Replacement: A Two-Year Clinical and DXA Analysis
|
||
Enrolling by invitation |
NCT03576573 -
Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components
|
||
Completed |
NCT02967874 -
Autologous Adipose-Derived Stromal Vascular Fraction Cells for Osteoarthritis Treatment
|
Phase 1/Phase 2 | |
Completed |
NCT02390336 -
Mobilization With Movement in Patients With Osteoarthritis of the Hip
|
N/A | |
Terminated |
NCT03293719 -
Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr or Ceramic
|
||
Active, not recruiting |
NCT02823834 -
PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components
|