An interventional study of Volar locking plate and external fixation in Radius Fracture Distal, Surgery and Surgery--Complications, sponsored by Olof Skoldenberg. Status unknown at 1 site in Sweden. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2022-05-12.
Sponsored by Olof Skoldenberg · Not applicable, Interventional, and Treatment
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.
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
670 studies on the registry are indexed under Surgical Wound Infection; 141 are open to participants now.
This study's planned enrollment of 203 is close to the median of 200 across 514 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Olof Skoldenberg is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DS center
SÖS center
Exclusion Criteria:
DS center:
SÖS center:
Surgery with volar locking plate
Procedure: Volar locking plate
Surgery with external fixation
Procedure: external fixation
Volar locking plate is the intervention
surgery with external fixation
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).
Time frame: 10 years after initial surgery
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)
Time frame: 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.
Time frame: 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.
Time frame: 10 years after initial surgery
Journal investigation
A journal assesment to find complications as infections, reoperations, CRPS, nerv injuries.
Time frame: 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).
Time frame: 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.
Time frame: 10 year after initial surgery.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Olof Skoldenberg