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

Primary Purpose

Radius Fracture Distal, Surgery, Surgery--Complications

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Volar locking plate
external fixation
Sponsored by
Olof Skoldenberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radius Fracture Distal

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of OrtopeadicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Volar Locking Plate

External fixation

Arm Description

Surgery with volar locking plate

Surgery with external fixation

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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.
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.
Journal investigation
A journal assesment to find complications as infections, reoperations, CRPS, nerv injuries.
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).
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.

Full Information

First Posted
April 1, 2022
Last Updated
May 10, 2022
Sponsor
Olof Skoldenberg
Collaborators
The Swedish Association for Survivors of Accident and Injury
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1. Study Identification

Unique Protocol Identification Number
NCT05371938
Brief Title
Volar Locking Plate Versus External Fixation for Distal Radius Fracture - a Longterm Follow up
Acronym
EXTEND
Official Title
Longterm Follow up for Displaced Distal Radius Fracture Randomized to Surgery With Volar Locking Plate or External Fixation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Olof Skoldenberg
Collaborators
The Swedish Association for Survivors of Accident and Injury

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fracture Distal, Surgery, Surgery--Complications, Treatment Complication, Tendon Injuries, Tendon Rupture, Surgical Site Infection, CRPS Type I, CRPS Type II, Dislocation, Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
203 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Volar Locking Plate
Arm Type
Experimental
Arm Description
Surgery with volar locking plate
Arm Title
External fixation
Arm Type
Active Comparator
Arm Description
Surgery with external fixation
Intervention Type
Procedure
Intervention Name(s)
Volar locking plate
Intervention Description
Volar locking plate is the intervention
Intervention Type
Procedure
Intervention Name(s)
external fixation
Intervention Description
surgery with external fixation
Primary Outcome Measure Information:
Title
Disability of the arm shoulder and hand (DASH)
Description
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
Secondary Outcome Measure Information:
Title
Patient rated wrist evaluation (PRWE)
Description
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
Title
Radiological assesment
Description
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
Title
Objective tests of range of motion (ROM)
Description
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
Title
Journal investigation
Description
A journal assesment to find complications as infections, reoperations, CRPS, nerv injuries.
Time Frame
0-10 years after initial surgery
Title
EQ-5D
Description
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
Title
Objective test of grip strength
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olof Sköldenberg, Professor
Phone
0046812357245
Email
olof.skoldenberg@regionstockholm.se
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Severin, MD
Phone
0046812356504
Email
sara.l.severin@regionstockholm.se
Facility Information:
Facility Name
Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Ortopeadics
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olof Sköldenberg, Professor
Phone
004612357245
Email
olof.skoldenberg@ki.se
First Name & Middle Initial & Last Name & Degree
Sara Severin, MD
Phone
0046812356504
Email
sara.l.severin@regionstockholm.se

12. IPD Sharing Statement

Plan to Share IPD
No

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

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