About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant has a stage II or III scapholunate advanced collapse (SLAC) or scaphoid nonunion advanced collapse (SNAC) wrist and is a surgical candidate for the included surgical interventions
Disqualifiers
Participant has been diagnosed with other forms of wrist arthritis other than SLAC or SNAC
Participant has significant arthritis of the ipsilateral hand/finger joint(s), major joint trauma, previous major wrist surgery, infection or neuromuscular pathology affecting the function of the ipsilateral upper extremity or ability to make a fist
Participant has a physical or mental health condition preventing completion of consent or questionnaires
Participant does not speak/read/understand English
Trial design
Parallel
Treatments tested in this trial
Four-Corner Arthrodesis
Procedure/SurgeryParticipants in Group A will receive a four-corner arthrodesis (fusion of the capitate, hamate, lunate, and triquetrum) with excision of the scaphoid.
Three-Corner or Capitolunate Arthrodesis with Triquetral Excision
Procedure/SurgeryParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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University of Alberta
Lead sponsor
Arthritis Society Canada
Collaborator
Wrist Evaluation Canada (WECAN)
Collaborator