Randomized Comparison of PARtial Wrist Fusion With or Without Triquetral Excision (PARTE)
NCT ID: NCT04580225
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
170 participants
INTERVENTIONAL
2021-01-07
2027-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A: Partial Wrist Arthrodesis without Triquetral Excision
Four-Corner Arthrodesis
Four-Corner Arthrodesis
Participants in Group A will receive a four-corner arthrodesis (fusion of the capitate, hamate, lunate, and triquetrum) with excision of the scaphoid.
Group B: Partial Wrist Arthrodesis with Triquetral Excision
Three-Corner or Capitolunate Arthrodesis with Triquetral Excision
Three-Corner or Capitolunate Arthrodesis with Triquetral Excision
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.
Interventions
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Four-Corner Arthrodesis
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
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
* Participant has no fixed address or means of contact
* Participant is unwilling to complete necessary follow-ups
* Surgeon concludes that eligible salvage techniques are not appropriate at the time of surgery (based on injury characteristics or concomitant wrist pathology)
18 Years
75 Years
ALL
No
Sponsors
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Arthritis Society Canada
UNKNOWN
Wrist Evaluation Canada (WECAN)
UNKNOWN
University of Alberta
OTHER
Responsible Party
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Locations
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Peter Lougheed Centre
Calgary, Alberta, Canada
South Health Campus
Calgary, Alberta, Canada
Western Hand & Upper Limb Facility, Sturgeon Community Hospital
St. Albert, Alberta, Canada
Lawson Health Research Institute
London, Ontario, Canada
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Countries
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Central Contacts
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Collaborative Orthopaedic Research (CORe)
Role: CONTACT
Facility Contacts
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Research Coordinator, Sturgeon Community Hospital
Role: primary
Other Identifiers
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Pro00099049
Identifier Type: -
Identifier Source: org_study_id
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