Volar Locking Plate Versus External Fixation for Distal Radius Fracture - a Longterm Follow up

Study Overview
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Brief Summary
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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
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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

Official Title
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Longterm Follow up for Displaced Distal Radius Fracture Randomized to Surgery With Volar Locking Plate or External Fixation

Conditions
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Radius Fracture Distal, Surgery, Surgery--Complications, Treatment Complication, Tendon Injuries, Tendon Rupture, Surgical Site Infection, CRPS Type I, CRPS Type II, Dislocation, Osteoarthritis

Intervention / Treatment
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* Procedure: Volar locking plate
* Procedure: external fixation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volar Locking Plate<br>Surgery with volar locking plate | Procedure: Volar locking plate<br>* Volar locking plate is the intervention<br>|
| Active Comparator: External fixation<br>Surgery with external fixation | Procedure: external fixation<br>* surgery with external fixation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability of the arm shoulder and hand (DASH) | 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). | 10 years after initial surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient rated wrist evaluation (PRWE) | 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) | 10 years after initial surgery | 
| Radiological assesment | 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. | 10 years after initial surgery | 
| Objective tests of range of motion (ROM) | pronation and supination, ulnar- and radial deviation, volar flexion and doral extension of both wrists with a goniometer, units will be degrees. | 10 years after initial surgery | 
| Journal investigation | A journal assesment to find complications as infections, reoperations, CRPS, nerv injuries. | 0-10 years after initial surgery | 
| EQ-5D | 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). | 10 years after initial surgery | 
| Objective test of grip strength | 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. | 10 year after initial surgery. |