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

Surgery Clinical Trial

— EXTEND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05371938
• Other study ID #: Handledsstudien 1
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: October 2023

Study information

• Verified date: May 2022
• Source: Danderyd Hospital
• Contact: Olof Sköldenberg, Professor
• Phone: 0046812357245
• Email: olof.skoldenberg[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 203
• Est. completion date: October 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Causalgia
• CRPS Type I
• CRPS Type II
• Dislocation
• Fractures, Bone
• Osteoarthritis
• Radius Fracture Distal
• Radius Fractures
• Reflex Sympathetic Dystrophy
• Rupture
• Surgery
• Surgery--Complications
• Surgical Site Infection
• Surgical Wound Infection
• Tendon Injuries
• Tendon Rupture
• Treatment Complication

Intervention

Procedure:
• Volar locking plate
Volar locking plate is the intervention
• external fixation
surgery with external fixation

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Ortopeadics	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Olof Skoldenberg	The Swedish Association for Survivors of Accident and Injury

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Journal investigation	A journal assesment to find complications as infections, reoperations, CRPS, nerv injuries.	0-10 years after initial surgery
Secondary	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
Secondary	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.