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

NCT04580225 | Recruiting

• 1 other identifier: Pro00099049
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Wrist Arthritis; Wrist Arthropathy; Scapholunate Advanced Collapse; Scaphoid Nonunion; Post-traumatic; Arthrosis; Arthritis; Musculoskeletal Diseases; Joint Diseases

Keywords

Post-traumatic wrist arthritis; Partial wrist fusions; Scapholunate advanced collapse; SLAC wrist; Scaphoid nonunion advanced collapse; SNAC wrist; Four-corner fusion; Bicolumnar wrist fusion; Three-corner fusion; Capitolunate fusion

Outcome Measures

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.

  Completed at baseline (pre-surgery), 3-, 6-, 12-months post-surgery

Secondary Outcomes (7)

• Wrist Range of Motion (ROM)

  Baseline, 3-, 6-, 12-months post-surgery

• Patient-Reported Outcomes Measurement Information System® (PROMIS)

  Baseline, 6-weeks, 3-, 6-, 12-months post-surgery

• Patient-Rated Wrist Evaluation (PRWE) Questionnaire

  Baseline, 6-weeks, 3-, 6-, 12-months post-surgery

• Visual Analog Scale (VAS) Pain Score

  Baseline, 6-weeks, 3-, 6-, 12-months post-surgery

• Complications

  6-weeks, 3-, 6-, 12-months post-surgery

Study Arms (2)

Group A: Partial Wrist Arthrodesis without Triquetral Excision

ACTIVE COMPARATOR

Four-Corner Arthrodesis

Procedure: Four-Corner Arthrodesis

Group B: Partial Wrist Arthrodesis with Triquetral Excision

ACTIVE COMPARATOR

Three-Corner or Capitolunate Arthrodesis with Triquetral Excision

Procedure: Three-Corner or Capitolunate Arthrodesis with Triquetral Excision

Interventions

Four-Corner Arthrodesis PROCEDURE

Participants in Group A will receive a four-corner arthrodesis (fusion of the capitate, hamate, lunate, and triquetrum) with excision of the scaphoid.

Group A: Partial Wrist Arthrodesis without Triquetral Excision

Three-Corner or Capitolunate Arthrodesis with Triquetral Excision PROCEDURE

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.

Group B: Partial Wrist Arthrodesis with Triquetral Excision

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of Alberta: lead
• Arthritis Society Canada: collaborator
• Wrist Evaluation Canada (WECAN): collaborator

Study Sites (6)

Peter Lougheed Centre

Calgary, Alberta, Canada

RECRUITING

South Health Campus

Calgary, Alberta, Canada

RECRUITING

Western Hand & Upper Limb Facility, Sturgeon Community Hospital

St. Albert, Alberta, Canada

RECRUITING

Lawson Health Research Institute

London, Ontario, Canada

RECRUITING

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, Canada

RECRUITING

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Arthritis; Musculoskeletal Diseases; Joint Diseases

Condition Hierarchy (Ancestors)

Rheumatic Diseases

Central Study Contacts

Dr. Armin Badre, MD, MSc, FRCSC

CONTACT

(780) 569-5494; badre@ualberta.ca

Collaborative Orthopaedic Research (CORe)

CONTACT

(780) 492-0830

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 8, 2020
• Study Start: January 7, 2021
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CA (6)