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Procedure

Partial Wrist Fusion Techniques for Wrist Arthritis (PARTE Trial)

N/A
Recruiting
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
Participant has been diagnosed with other forms of wrist arthritis other than SLAC or SNAC
Participant is unwilling to complete necessary follow-ups
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-weeks, 3-, 6-, 12-months post-surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two techniques for partial wrist fusion in people with arthritis caused by prior injury. One group will have a four-corner fusion, and the other group will have a three-corner or capitolunate fusion with triquetral excision.

Who is the study for?
This trial is for people with stage II or III wrist arthritis from SLAC or SNAC who need surgery. It's not for those who can't read English, lack a stable address, won't do follow-ups, have other wrist arthritis types, mental/physical issues preventing consent, major hand joint problems, past major wrist surgery, infections or neuromuscular conditions affecting the arm.
What is being tested?
The study compares two partial wrist fusion surgeries in treating post-traumatic wrist arthritis: Group A gets four-corner arthrodesis without removing a bone called the triquetrum; Group B has three-corner arthrodesis with triquetral excision.
What are the potential side effects?
Potential side effects of these surgical procedures may include pain at the site of operation, reduced range of motion in the wrist, possible nerve damage leading to numbness or tingling sensations and complications related to healing such as infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a stage II or III wrist condition and am eligible for surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with a form of wrist arthritis that is not SLAC or SNAC.
Select...
I am unwilling to attend required follow-up visits.
Select...
I have severe arthritis, past major wrist surgery, or other conditions affecting my arm or hand function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-weeks, 3-, 6-, 12-months post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-weeks, 3-, 6-, 12-months post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Grip Strength
Secondary study objectives
Complications
Patient-Rated Wrist Evaluation (PRWE) Questionnaire
Patient-Reported Outcomes Measurement Information System® (PROMIS)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Group A: Partial Wrist Arthrodesis without Triquetral ExcisionActive Control1 Intervention
Four-Corner Arthrodesis
Group II: Group B: Partial Wrist Arthrodesis with Triquetral ExcisionActive Control1 Intervention
Three-Corner or Capitolunate Arthrodesis with Triquetral Excision

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
940 Previous Clinical Trials
433,911 Total Patients Enrolled
3 Trials studying Arthritis
1,021 Patients Enrolled for Arthritis
Arthritis Society CanadaUNKNOWN
Wrist Evaluation Canada (WECAN)UNKNOWN

Media Library

Four-Corner Arthrodesis (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04580225 — N/A
Arthritis Research Study Groups: Group A: Partial Wrist Arthrodesis without Triquetral Excision, Group B: Partial Wrist Arthrodesis with Triquetral Excision
Arthritis Clinical Trial 2023: Four-Corner Arthrodesis Highlights & Side Effects. Trial Name: NCT04580225 — N/A
Four-Corner Arthrodesis (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04580225 — N/A
~20 spots leftby Sep 2025
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