Proximal Row Carpectomy vs Four-corner Fusion for Osteoarthritis of the Wrist

Study Overview
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Brief Summary
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Study purpose is to compare the outcome after proximal row carpectomy (PRC) vs four-corner fusion (FCA) for SLAC/SNAC II-III type osteoarthritis (OA) in a double-blinded randomized controlled study setting. Patients with radiologically and clinically confirmed OA are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either PRC or FCA. The study will be patient and assessor blinded. Baseline data is collected preoperatively and is followed by a follow-up visits at 2 and 6 weeks, 3, 6, 12 months, and 5, 10 years after the intervention. Unveiling of the allocation is at 12 months post-intervention.

Official Title
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A Double-blinded Randomized Controlled Multicenter Trial Comparing Proximal ROw carpectOmy and Four-corner Fusion (PROOF) for Osteoarthritis of the Wrist

Conditions
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Wrist Osteoarthritis, Scapholunate Advanced Collapse

Intervention / Treatment
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* Procedure: Proximal Row Carpectomy
* Procedure: Four-corner fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SLAC/SNAC II-III Age 18 - 75 Symptom duration > 3 months American Society of Anaesthesiologists physical status (ASA) I-II Exclusion Criteria: Patient eligible for SL reconstruction or scaphoid Ulnocarpal/pancarpal arthritis Lunate fossa, proximal lunate arthrosis or both Age <18 or >75 years Rheumatoid arthritis Heavy smoking (> 20 cigarettes per day) Condition or medication affecting bony healing (eg diabetes mellitus with poor glycemic control, malnutrition, use of per oral corticosteroids) Alcohol or drug abuse Neurological condition affecting upper limb function

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proximal Row Carpectomy<br> | Procedure: Proximal Row Carpectomy<br>* Excision of the proximal carpal row - the scaphoid, lunate and triquetrum<br>|
| Active Comparator: Four-corner fusion<br> | Procedure: Four-corner fusion<br>* Scaphoid excision and four-corner fusion with cannulated headless compression screws/dorsal plate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Rated Wrist Evaluation | The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick-Disabilities of the Arm, Shoulder and Hand | The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale (1=best possible outcome, 5=worst possible outcome) | 12 months | 
| Pain (Visual Analogue Scale) | The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain) | 12 months | 
| Global improvement | Global rating to treatment effect will be evaluated by question: How would you rate the function of your hand compared to the situation before the treatment?. The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better | 12 months | 
| Grip strength | Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side | 12 months | 
| Wrist range of motion (ROM) | Wrist ROM is measured on both wrists with a handheld goniometer in degrees. | 12 months | 
| Complications | Incidence of complications (i.e. non-union, fracture, reoperation, infection, hematoma, iatrogenic tendon/nerve/arterial injury, complex regional pain syndrome) is recorded and compared between study groups. | 12 months | 
| Patient-rated Quality of Life (EQ-5D) |  | 12 months | 
| Cost-effectiveness | Quality-adjusted life years/months measured as a change in EQ-5D | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wrist Osteoarthritis, Scapholunate Advanced Collapse, Scaphoid Non-union Advanced Collapse, Wrist arthrodesis, Proximal Row Carpectomy