An interventional study of Four-Corner Arthrodesis and Three-Corner or Capitolunate Arthrodesis with Triquetral Excision in Wrist Arthritis, Wrist Arthropathy and Scapholunate Advanced Collapse, sponsored by University of Alberta. Recruiting at 5 sites in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
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.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 170 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
Four-Corner Arthrodesis
Procedure: Four-Corner Arthrodesis
Three-Corner or Capitolunate Arthrodesis with Triquetral Excision
Procedure: Three-Corner or Capitolunate Arthrodesis with Triquetral Excision
Participants in Group A will receive a four-corner arthrodesis (fusion of the capitate, hamate, lunate, and triquetrum) with excision of the scaphoid.
Participants in Group B will receive a three-corner arthrodesis (fusion of the capitate, hamate, and lunate) or capitolunate arthrodesis (fusion of the capitate and lunate) with excision of the scaphoid and triquetrum.
Grip Strength
Peak grip strength will be assessed using a hand-held dynamometer. Grip strength will be compared between groups over the 12-month evaluation period.
Time frame: Completed at baseline (pre-surgery), 3-, 6-, 12-months post-surgery
Wrist Range of Motion (ROM)
Active and passive wrist ROM will be assessed using a goniometer. ROM will be compared between groups over the 12-month evaluation period.
Time frame: Baseline, 3-, 6-, 12-months post-surgery
Patient-Reported Outcomes Measurement Information System® (PROMIS)
PROMIS questionnaire will be used to assess self-reported physical function, upper extremity, pain interference, emotional distress. PROMIS scores will be compared between groups over the 12-month evaluation period.
Time frame: Baseline, 6-weeks, 3-, 6-, 12-months post-surgery
Patient-Rated Wrist Evaluation (PRWE) Questionnaire
Pain and function from 0-10 will be self-reported using the PRWE. PRWE scores will be compared between groups over the 12-month evaluation period.
Time frame: Baseline, 6-weeks, 3-, 6-, 12-months post-surgery
Visual Analog Scale (VAS) Pain Score
Pain will be self-reported using VAS where zero equals no pain and 10 represents the worst possible pain. VAS pain scores will be compared between groups over the 12-month evaluation period.
Time frame: Baseline, 6-weeks, 3-, 6-, 12-months post-surgery
Complications
Complications including infection and nonunion will be compared between groups over the 12-month evaluation period.
Time frame: 6-weeks, 3-, 6-, 12-months post-surgery
Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire - work and sports/performing arts modules
The work and sports/performing arts modules of the QuickDASH will be collected to measure the extent that participants experience limitations in their work and recreational activities, as applicable. Scores will be compared between groups.
Time frame: Baseline, 12-months post-surgery
WOrk-Related Questionnaire for UPper extremity disorders (WORQ-UP) questionnaire
The WORQ-UP will be collected to measure the extent that participants experience limitations in their work, as applicable. Scores will be compared between groups.
Time frame: Baseline, 12-months post-surgery
Started Jan 2021 (actual). Primary completion is estimated for Apr 2027, 75 months after the start.
Of 578 non-industry interventional studies with no phase under Osteoarthritis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 52. This study's planned 75 months is above that.
Counting every sponsor, half of 713 studies reached it within 29 months; a quarter within 11 and three quarters within 58.
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