Proximal Row Carpectomy vs Four-corner Fusion for Osteoarthritis of the Wrist
- Conditions
- Wrist OsteoarthritisScapholunate Advanced Collapse
- Interventions
- Procedure: Four-corner fusionProcedure: Proximal Row Carpectomy
- Registration Number
- NCT04260165
- Lead Sponsor
- Töölö Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 84
- SLAC/SNAC II-III
- Age 18 - 75
- Symptom duration > 3 months
- American Society of Anaesthesiologists physical status (ASA) I-II
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Four-corner fusion Four-corner fusion - Proximal Row Carpectomy Proximal Row Carpectomy -
- Primary Outcome Measures
Name Time Method Patient-Rated Wrist Evaluation 12 months 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)
- Secondary Outcome Measures
Name Time Method Quick-Disabilities of the Arm, Shoulder and Hand 12 months 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)
Pain (Visual Analogue Scale) 12 months The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain)
Patient-rated Quality of Life (EQ-5D) 12 months Global improvement 12 months 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
Grip strength 12 months 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
Wrist range of motion (ROM) 12 months Wrist ROM is measured on both wrists with a handheld goniometer in degrees.
Cost-effectiveness 12 months Quality-adjusted life years/months measured as a change in EQ-5D
Complications 12 months 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.
Trial Locations
- Locations (5)
Töölö Hospital (Helsinki University Hospital)
🇫🇮Helsinki, Finland
Central Hospital of Central Finland
🇫🇮Jyväskylä, Finland
Kymenlaakso Central Hospital
🇫🇮Kotka, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
Turku University Hospital
🇫🇮Turku, Finland