Arthritis Clinical Trial
Official title:
Randomized Comparison of PARtial Wrist Fusion With or Without Triquetral Excision (PARTE)
This randomized clinical trial (RCT) aims to compare clinical and radiographic outcomes of different partial wrist fusion techniques in participants with post-traumatic wrist arthritis. Participants with stage II or III scapholunate advanced collapse (SLAC) or scaphoid nonunion advanced collapse (SNAC) who meet the eligibility criteria will be randomly assigned to one of two parallel groups: Group A (partial wrist arthrodesis without triquetral excision i.e. four-corner arthrodesis), or Group B (partial wrist arthrodesis with triquetral excision i.e. three-corner or capitolunate arthrodesis with triquetral excision). The results of this study will provide evidence to guide surgeons in determining the ideal wrist fusion technique in the management of patients with post-traumatic wrist arthritis requiring surgery.
This study has been designed as a multi-center double-blind prospective randomized clinical trial. Eligible participants will be adults presenting with SNAC or SLAC wrist arthritis who have been deemed an operative candidate and qualify for one of the following salvage techniques: four-corner arthrodesis (without triquetral excision) or three-corner/capitolunate arthrodeses with triquetral excision. Once eligibility is confirmed, participants will be randomly assigned to one of two treatment arms. Participants in Group A will undergo four-corner arthrodesis; the scaphoid will be excised and the lunate, capitate, triquetrum, and hamate will be prepared and fused. Participants in Group B will undergo partial wrist arthrodesis with triquetral excision; the scaphoid and triquetrum will be excised. In the three-corner arthrodesis procedure, the articular surfaces between the lunate, capitate, and hamate will be prepared and fused. In the capitolunate arthrodesis procedure, only the articular surface between the lunate and capitate will be prepared and fused. Eligible and consented participants will undergo a pre-operative study assessment and follow-up assessments at 6-weeks, 3-, 6-, and 12-months post-operative. Assessments will be conducted by an assessor blinded to participant treatment allocation. At each assessment, grip strength, wrist range of motion (ROM), Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire, Patient-Rated Wrist Evaluation (PRWE) questionnaire, and Visual Analog Scale (VAS) for pain will be completed. The work and sports/performing arts modules of the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH), and the WOrk-Related Questionnaire for UPper extremity disorders (WORQ-UP), will be completed at baseline (pre-surgery) and at 12-months. Standard posteroanterior and lateral radiographs will be completed at all visits. Complications will be documented at each visit. The primary outcome, grip strength, will be measured with a handheld dynamometer. Absolute values and percentage of their contralateral side will be compared between the two groups. Statistical analysis will use the intention-to-treat approach with all outcomes attributed to the assigned group. Descriptive statistics will be used for group comparisons with independent t-tests for continuous and Pearson Chi-square or Fisher's Exact tests for categorical variables at baseline and for possible complications/adverse events. Linear Mixed Modeling (LMM), adjusted for age and sex, will compare outcomes between groups over the 12-month evaluation period. The level of significance will be set at α=0.05. This study hypothesizes that partial wrist fusion with triquetral excision will lead to improved grip strength and ROM compared to four-corner arthrodesis. Considering the importance of ROM and grip strength in many activities of daily living and manual work, it is hypothesized that the group with triquetral excision (Group B) will have better patient-reported outcomes. We hypothesize no significant difference between the groups with regards to radiographic outcomes and complications. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04228458 -
ThermRheum Version 1
|
N/A | |
Withdrawn |
NCT04976972 -
A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation
|
N/A | |
Completed |
NCT04037436 -
Functional Exercise and Nutrition Education Program for Older Adults
|
N/A | |
Completed |
NCT00069342 -
Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
|
||
Completed |
NCT02944448 -
A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee
|
Phase 2 | |
Recruiting |
NCT02498808 -
Interferon-lambda: Novel Biologics for Controlling Neutrophil-mediated Pathology in Rheumatic Diseases?
|
N/A | |
Recruiting |
NCT02777060 -
Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures
|
N/A | |
Enrolling by invitation |
NCT02487888 -
A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care
|
N/A | |
Withdrawn |
NCT02136251 -
Total Shoulder Replacement Outcomes With Autologous Bone Graft as Fixator for Glenoid Anchor Peg.
|
||
Completed |
NCT02143206 -
Modifying Exercise for the COPD Patient
|
||
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 |
NCT01285843 -
Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component
|
N/A | |
Completed |
NCT00987870 -
Safety and Efficacy of BFH772 in Psoriasis Patients
|
Phase 1/Phase 2 | |
Completed |
NCT01172327 -
Self-Directed Exercise Program for Adults With Arthritis
|
N/A | |
Completed |
NCT01184924 -
Evaluation of the Arthritis Foundation Tai Chi Program
|
N/A | |
Completed |
NCT00750984 -
A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing
|
N/A | |
Active, not recruiting |
NCT00611585 -
A Safety and Efficacy Study of the Birmingham Hip Resurfacing System
|
N/A | |
Completed |
NCT00379184 -
Sensitization in Osteoarthritic Knees
|
N/A | |
Completed |
NCT00403676 -
Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease
|
N/A | |
Completed |
NCT00175448 -
Comparison of Physiotherapy Versus Home Exercise Following Hip Replacement Surgery
|
N/A |