Randomized Comparison of PARtial Wrist Fusion With or Without Triquetral Excision (PARTE)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Alberta

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Four-Corner Arthrodesis

    Procedure/Surgery

    Participants 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/Surgery

    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.

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Group A: Partial Wrist Arthrodesis without Triquetral ExcisionActive comparator 1 intervention
Group B: Group B: Partial Wrist Arthrodesis with Triquetral ExcisionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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University of Alberta

Lead sponsor

Arthritis Society Canada

Collaborator

Wrist Evaluation Canada (WECAN)

Collaborator