- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04580225
Randomized Comparison of PARtial Wrist Fusion With or Without Triquetral Excision (PARTE) (PARTE)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr. Armin Badre, MD, MSc, FRCSC
- Phone Number: (780) 569-5494
- Email: badre@ualberta.ca
Study Contact Backup
- Name: Collaborative Orthopaedic Research (CORe)
- Phone Number: (780) 492-0830
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada
- Recruiting
- Peter Lougheed Centre
-
Principal Investigator:
- Kevin Hildebrand, MD, FRCSC, CCPE
-
Contact:
- Gerardo Duque, MA
- Phone Number: 403-943-5556
- Email: gerardo.duque@ucalgary.ca
-
Calgary, Alberta, Canada
- Recruiting
- South Health Campus
-
Contact:
- Adina Tarcea
- Phone Number: 403-956-3687
- Email: adina.tarcea@ucalgary.ca
-
Principal Investigator:
- Neil White, MD, FRCSC
-
St. Albert, Alberta, Canada
- Recruiting
- Western Hand & Upper Limb Facility, Sturgeon Community Hospital
-
Contact:
- Collaborative Orthopaedic Research
- Phone Number: (780) 492-0830
-
-
Ontario
-
Ottawa, Ontario, Canada
- Recruiting
- The Ottawa Hospital - Civic Campus
-
Contact:
- Nidhi Agrawal
- Email: nagrawal@ohri.ca
-
Principal Investigator:
- Manisha Mistry, MD, MSc, FRCSC
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada
- Recruiting
- University of Saskatchewan
-
Contact:
- Laura A. Sims, MD, FRCSC
- Email: laurasims710@gmail.com
-
Principal Investigator:
- Laura A. Sims, MD, FRCSC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A: Partial Wrist Arthrodesis without Triquetral Excision
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.
|
Active Comparator: Group B: Partial Wrist 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grip Strength
Time Frame: Completed at baseline (pre-surgery), 3-, 6-, 12-months post-surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wrist Range of Motion (ROM)
Time Frame: Baseline, 3-, 6-, 12-months post-surgery
|
Active and passive wrist ROM will be assessed using a goniometer.
ROM will be compared between groups over the 12-month evaluation period.
|
Baseline, 3-, 6-, 12-months post-surgery
|
Patient-Reported Outcomes Measurement Information System® (PROMIS)
Time Frame: Baseline, 6-weeks, 3-, 6-, 12-months post-surgery
|
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.
|
Baseline, 6-weeks, 3-, 6-, 12-months post-surgery
|
Patient-Rated Wrist Evaluation (PRWE) Questionnaire
Time Frame: Baseline, 6-weeks, 3-, 6-, 12-months post-surgery
|
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.
|
Baseline, 6-weeks, 3-, 6-, 12-months post-surgery
|
Visual Analog Scale (VAS) Pain Score
Time Frame: Baseline, 6-weeks, 3-, 6-, 12-months post-surgery
|
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.
|
Baseline, 6-weeks, 3-, 6-, 12-months post-surgery
|
Complications
Time Frame: 6-weeks, 3-, 6-, 12-months post-surgery
|
Complications including infection and nonunion will be compared between groups over the 12-month evaluation period.
|
6-weeks, 3-, 6-, 12-months post-surgery
|
Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire - work and sports/performing arts modules
Time Frame: Baseline, 12-months post-surgery
|
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.
|
Baseline, 12-months post-surgery
|
WOrk-Related Questionnaire for UPper extremity disorders (WORQ-UP) questionnaire
Time Frame: Baseline, 12-months post-surgery
|
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.
|
Baseline, 12-months post-surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00099049
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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