Fusion; Joint, Wrist Arthritis
Conditions
Brief summary
Study purpose is to compare the outcome after total wrist arthrodesis (TWA) with proximal carpal row (Proximal Row Carpectomy = PRC) as bone graft versus iliac crest cancellous bone graft. Patients with radiologically and clinically confirmed advanced osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either total wrist arthrodesis with PRC or TWA with iliac crest bone grafting. Baseline data is collected preoperatively and is a follow-up visits at every 6 weeks after the surgery is arranged until the wrist is fused. The primary end-point is 6 months and the primary outcome is fusion rate.
Interventions
PROCEDUREPRC
Total wrist arthrodesis with dorsal plate using proximal row of the wrist as bone graft
PROCEDURETWA
Total wrist arthrodesis with dorsal plate using iliac crest as bone graft
Sponsors
Turku University Hospital
Kymenlaakso Central Hospital Kotka Finland
Töölö Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 - 75 * Symptom duration \> 3 months * American Society of Anaesthesiologists physical status (ASA) I-III * Fluent in written and spoken Finnish
Exclusion criteria
* 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) * Ulnar variance \> 1 mm * Wrist pain treatable with partial wrist fusion * Previous partial wrist fusion * Alcohol or drug abuse * Neurological condition affecting upper limb function * Less than 6 months after another operation of the same upper limb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusion rate (percent) | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Rated Wrist Evaluation (PRWE) | 6 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) |
| Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH) | 6 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) |
| Global improvement | 6 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 |
| Pain (Visual Analogue Scale) | 6 months | The VAS is derived by health care professional question of pain in scale 0 to 100 mm (0 mm =no pain, 100 mm =worst possible pain) |
| Operative time | Perioperative | Operative time is measured in minutes for time in the operation theatre and time used for surgery |
| Complications | 12 months | Incidence of complications (i.e. non-union, fracture, re-operation, infection, hematoma, iatrogenic tendon/nerve/arterial injury, complex regional pain syndrome) is recorded and compared between study groups. |
| Grip strength | 6 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 |
Contacts
Primary ContactSamuli Aspinen, M.D., Ph.D.
Backup ContactJorma Ryhänen, adj. prof.
Outcome results
None listed