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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis; Tendon Injuries; Surgery; Surgery--Complications; Surgical Site Infection; Radius Fracture Distal; Dislocation; CRPS Type I; Tendon Rupture; Treatment Complication; CRPS Type II
• Intervention / Treatment: Procedure: Volar locking plate; Procedure: 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

• Study Type: Interventional
• Enrollment (Anticipated): 203
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olof Sköldenberg, Professor; Phone Number: 0046812357245; Email: olof.skoldenberg@regionstockholm.se
• Study Contact Backup: Name: Sara Severin, MD; Phone Number: 0046812356504; Email: sara.l.severin@regionstockholm.se

Study Locations

• Sweden
  • Stockholm, Sweden, 182 88
    • Recruiting
    • Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Ortopeadics
    • Contact: Sara Severin, MD; Phone Number: 0046812356504; Email: sara.l.severin@regionstockholm.se
    • Contact: Olof Sköldenberg, Professor; Phone Number: 004612357245; Email: olof.skoldenberg@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Volar Locking Plate; Surgery with volar locking plate	Procedure: Volar locking plate; Volar locking plate is the intervention
Active Comparator: External fixation; Surgery with external fixation	Procedure: external fixation; surgery with external fixation

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Olof Skoldenberg
• Collaborators: The Swedish Association for Survivors of Accident and Injury

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Infections; Postoperative Complications; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Autonomic Nervous System Diseases; Wound Infection; Arm Injuries; Forearm Injuries; Complex Regional Pain Syndromes; Rupture; Reflex Sympathetic Dystrophy; Fractures, Bone; Surgical Wound Infection; Radius Fractures; Causalgia; Tendon Injuries
• Other Study ID Numbers: Handledsstudien 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No