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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
Excision of the proximal carpal row - the scaphoid, lunate and triquetrum
Scaphoid excision and four-corner fusion with cannulated headless compression screws/dorsal plate
Töölö Hospital (Helsinki University Hospital)
Helsinki, Finland
RECRUITINGCentral Hospital of Central Finland
Jyväskylä, Finland
NOT_YET_RECRUITINGKymenlaakso Central Hospital
Kotka, Finland
NOT_YET_RECRUITINGTampere University Hospital
Tampere, Finland
NOT_YET_RECRUITINGTurku University Hospital
Turku, Finland
NOT_YET_RECRUITINGPatient-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)
Time frame: 12 months
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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 12 months
Wrist range of motion (ROM)
Wrist ROM is measured on both wrists with a handheld goniometer in degrees.
Time frame: 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.
Time frame: 12 months
Patient-rated Quality of Life (EQ-5D)
Time frame: 12 months
Cost-effectiveness
Quality-adjusted life years/months measured as a change in EQ-5D
Time frame: 12 months
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