Scapholunate Advanced Collapse, Wrist Osteoarthritis
Conditions
Keywords
Wrist Osteoarthritis, Scapholunate Advanced Collapse, Scaphoid Non-union Advanced Collapse, Wrist arthrodesis, Proximal Row Carpectomy
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.
Interventions
PROCEDUREProximal Row Carpectomy
Excision of the proximal carpal row - the scaphoid, lunate and triquetrum
PROCEDUREFour-corner fusion
Scaphoid excision and four-corner fusion with cannulated headless compression screws/dorsal plate
Sponsors
Tampere University Hospital
Turku University Hospital
Jyväskylä Central Hospital
Kymenlaakso Central Hospital Kotka Finland
Töölö Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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) |
| 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. |
| Patient-rated Quality of Life (EQ-5D) | 12 months | — |
| Cost-effectiveness | 12 months | Quality-adjusted life years/months measured as a change in EQ-5D |
| Wrist range of motion (ROM) | 12 months | Wrist ROM is measured on both wrists with a handheld goniometer in degrees. |
Countries
Finland
Contacts
Primary ContactSamuli Aspinen, MD, PhD
Backup ContactJorma Ryhänen, adj. prof.
Outcome results
None listed