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Wrist ArthritisPARTENCT04580225

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

A study testing Four-Corner Arthrodesis and Three-Corner or Capitolunate Arthrodesis with Triquetral Excision in people with Wrist Arthritis and Wrist Arthropathy, run by University of Alberta at 5 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Four-Corner Arthrodesis and Three-Corner or Capitolunate Arthrodesis with Triquetral Excision
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
5 sitesCanada
Study dates
7 Jan 2021to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dr. Armin Badre, MD, MSc, FRCSC contact

(780) 569-5494

badre@ualberta.ca

Collaborative Orthopaedic Research (CORe) contact

(780) 492-0830

5 sites in 1 country

Canada5 sites, 5 recruiting
  • South Health Campus

    Calgary, Alberta

    Sara Kayvani, 403-956-3687, sara.kayvani@ucalgary.ca

    Neil White, MD, FRCSC

    Recruiting
  • Lawson Health Research Institute

    London, Ontario

    Katrina Munro, katrina.munro@sjhc.london.on.ca

    Ruby Grewal, MD, FRCSC

    Recruiting
  • The Ottawa Hospital - Civic Campus

    Ottawa, Ontario

    Hoda Ghaziasgar, MSc, 613-737-8899 ext. 19217, hghaziasgar@ohri.ca

    Manisha Mistry, MD, MSc, FRCSC

    Recruiting
  • University of Saskatchewan

    Saskatoon, Saskatchewan

    Laura A. Sims, MD, FRCSC, laurasims710@gmail.com

    Laura A. Sims, MD, FRCSC

    Recruiting
  • Western Hand & Upper Limb Facility, Sturgeon Community Hospital

    St. Albert, Alberta

    Research Coordinator, Sturgeon Community Hospital, (780) 418-7410

    Armin Badre, MD, MSc, FRCSC

    Recruiting

Other trials in Canada

About this study

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.

Read the detailed description

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.

Being tested
Four-Corner Arthrodesis, Three-Corner or Capitolunate Arthrodesis with Triquetral Excision
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
Medical subject headings
Osteoarthritis, Arthritis, Musculoskeletal Diseases, Joint Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Four-Corner ArthrodesisProcedure or 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 ExcisionProcedure or 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.

Study groups in NCT04580225
Study groupRoleWhat they receive
Group A: Partial Wrist Arthrodesis without Triquetral ExcisionActive comparatorFour-Corner Arthrodesis
Receives: Procedure: Four-Corner Arthrodesis
Group B: Partial Wrist Arthrodesis with Triquetral ExcisionActive comparatorThree-Corner or Capitolunate Arthrodesis with Triquetral Excision
Receives: Procedure: Three-Corner or Capitolunate Arthrodesis with Triquetral Excision

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  5. Complications

    Complications including infection and nonunion will be compared between groups over the 12-month evaluation period.

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

  6. 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.

    Measured: Baseline, 12-months post-surgery

  7. 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.

    Measured: Baseline, 12-months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start7 Jan 2021
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04580225
Sponsor's protocol ID
Pro00099049
Acronym
PARTE
Status last verified
Jun 2026
First submitted
2 Oct 2020
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Four-Corner Arthrodesis and Three-Corner or Capitolunate Arthrodesis with Triquetral Excision in people with Wrist Arthritis and Wrist Arthropathy, run by University of Alberta at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr. Armin Badre, MD, MSc, FRCSC ((780) 569-5494, badre@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grip Strength (time frame: Completed at baseline (pre-surgery), 3-, 6-, 12-months post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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