Radius Fracture Distal, Surgery, Surgery--Complications, Treatment Complication, Tendon Injuries, Tendon Rupture, Surgical Site Infection, CRPS Type I, CRPS Type II, Dislocation, Osteoarthritis
Conditions
Brief summary
A 10-year follow up of a fusion of two earlier published randomized controlled trials. 203 patients with displaced distal radius fractures were randomized to surgery with a volar locking plate or external fixation.
Detailed description
Follow up includes PROMs (DASH, PRWE, EQ-5D), radiological assesment and objective tests by a hand occupational therapist (ROM, grip strength). Previous Clinical trials registration for the original studies this long-term follow up is a continuation on: NCT00989222, NCT01034943, NCT01035359
Interventions
PROCEDUREVolar locking plate
Volar locking plate is the intervention
PROCEDUREexternal fixation
surgery with external fixation
Sponsors
The Swedish Association for Survivors of Accident and Injury
Olof Skoldenberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
DS center * acute unilateral dorsally displaced distal radius fracture with a axial shortening of at least 4 mm or a dorsal displacement of at least 20 degrees. * Age 20-70 SÖS center * Age 50-74 for women and 60-74 for men * injury only after fall from a standing height * wrist radiography of at least 20 degrees dorsal dislocation and/or at least 5 mm axial shortening * good knowledge of written and spoken swedish * fracture diagnosed within 72 hours from injury * patient resident within the catchment area of SÖS center
Exclusion criteria
DS center: * no previous fracture of either wrist * ipsilateral acute fracture of the upper extremity * medicated with warfarin * unable to cooperate with follow-up (dementia, substance abuse, psychiatric illness, language problems) * open fracture * fracture that was not amenable by both methods (distal fragment to small or to comminuted) SÖS center: * former disability of either wrist * other concomitant injuries * rheumatoid arthritis or other severe joint disorder * Dementia or pfeiffer score under 5 points * drug abuse, alcohol abuse or psychiatric disorder * dependency in activity of daily living * medical condition contradicting general anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability of the arm shoulder and hand (DASH) | 10 years after initial surgery | PROM Patient Rated outcome Measurement. A 30-item questionnaire to assess musculoskeletal disorders in upper limbs. It also has two 4-items optional modules to assess function and symptoms in athletes, artists and workers. Item response range from 1 (no difficult) to 5 (unable). The total score ranges from 0 (no disability) to 100 (most severe disability). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiological assesment | 10 years after initial surgery | x-ray of both wrists, AP and lateral. Assessing radial inclination, dorsal tilt, ulnar variance. Osteoarthritis of the radioulnar joint and DRU-joint, fractures in carpus/ulna. VISI/DISI and SL-dissociation. |
| Objective tests of range of motion (ROM) | 10 years after initial surgery | pronation and supination, ulnar- and radial deviation, volar flexion and doral extension of both wrists with a goniometer, units will be degrees. |
| Patient rated wrist evaluation (PRWE) | 10 years after initial surgery | A patient rated outcome measurement(PROM) a subjective test of function by a 15-item questionnaire. PRWE is specific for wrist evaluation. It consists of two subscales - pain and function. Total score ranges from 0 (no disability) to 100 (severe disability) |
| EQ-5D | 10 years after initial surgery | A health related quality of life questionnaire. EQ-5D is the correct name and not an abbreviation. 5 dimensions of health is assessed (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) in three levels (no problems/some or moderate problems/extreme problems). The responses of EQ-5D can be converted to a singel number - a index value and compared with a value set. The index value reflects how good or bad the health statues is. There is also a visual analogue scale on overall health with the scale 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Objective test of grip strength | 10 year after initial surgery. | Test of grip strength by GRIPPIT units is Newton. Grip strength will be measured bilateral and presented as maximum, mean and value after 10 seconds. |
| Journal investigation | 0-10 years after initial surgery | A journal assesment to find complications as infections, reoperations, CRPS, nerv injuries. |
Countries
Sweden
Contacts
Primary ContactOlof Sköldenberg, Professor
Backup ContactSara Severin, MD
Outcome results
None listed