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Volar Internal Plate Fixation vs. Plaster in Extra- Articular Distal Radial Fractures (VIPER)

Primary Purpose

Displaced Extra-articular Distal Radius Fractures

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
open reduction and internal fixation
Closed reduction and plaster
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Displaced Extra-articular Distal Radius Fractures focused on measuring distal radius fractures, Closed reduction, Open reduction internal fixation, Volar plate, Redislocation, Unstable fracture, Extra-articular fracture, Colles fracture, Barton fracture

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients ≥ 18 years and ≤ 75 years
  • Extra-articular (AO type A) displaced distal radius fracture, as classified on lateral, posterior anterior and lateral carporadial radiographs by a radiologist or trauma surgeon.
  • Acceptable closed reduction obtained according to current Dutch guidelines within 12 hours after presentation at the Emergency Department (ED).

Exclusion Criteria:

  • Open distal radius fractures
  • Multiple trauma patients (Injury Severity Score (ISS) ≥16)
  • Other fractures of the affected extremity
  • Patients with impaired wrist function prior to injury due to arthritis/neurological disorders of the upper limb
  • Patient suffering from disorders of bone metabolism, connective tissue or (joint) hyperflexibility.
  • Insufficient comprehension of the Dutch language to understand the treatment information and informed consent forms as judged by the attending physician.

Sites / Locations

  • Academic Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Closed reduction and plaster

open reduction and internal fixation

Arm Description

Closed reduction will be performed and after adequate reduction has been confirmed, the wrist will be immobilised according to Dutch guidelines: a splint for one week followed by a circular cast for another four weeks.

The intervention group will be treated with open reduction and internal fixation with a volar locking plate.

Outcomes

Primary Outcome Measures

Wrist function/pain/disability at one year assessed with DASH score
the primary endpoint of this study is wrist function, pain and disability as measured with the DASH score. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb.

Secondary Outcome Measures

Wrist function at one year assessed with PRWE score
The PRWE questionnaire is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of three subscales: Pain, Function and Cosmetics.
Quality of Life
Quality of Life assessed using the Short Form-36 (SF-36) questionnaire. The SF-36 is a validated multipurpose, short form health survey which contains 36 questions representing eight different health domains. These domains are combined into a mental and physical component scale. From each domain, scores ranging from 0 to 100 points are derived, with lower scores indicating poorer quality of life.
Pain
Pain as indicated on a visual Analogue Scale (VAS), in which 0 implies no pain and 10 the worst possible pain. Patients will be asked to give an estimation of the type and quantity of pain medication taken during all follow-up visits.
Patient satisfaction
Patient satisfaction at one year by simply asking patients if they are satisfied with the result (yes/no).
Range of motion
Range of motion of the wrist measured on both sides with a handheld goniometer.
Grip strength
Grip strength as measured with a dynamometer.
Radiological parameters
Radiological parameters: radial inclination, volar/dorsal tilt, comminution, ulnar variance and radial length measured digitally in the Picture Archiving and Communication System (PACS) on standard posterior anterior (PA), lateral carporadial and lateral X-rays of the wrist. Radiographs will be obtained according to standardised procedures. PA radiographs with the shoulder in 90 degrees abduction, elbow in 90 degrees flexion and the wrist in neutral position; lateral X-rays with the shoulder in neutral position and elbow in 90 degrees flexion; and the lateral carporadial radiographs will be obtained by positioning the lower arm on a 20-25 degrees angled wedge.
Complications
Complication rate such as: loss of reduction, cross-overs from conservative to operative treatment, fracture malunion or non-union, wound and/or plate infection, tendon irritation and/or rupture, neuropathy and the occurrence of complex regional pain syndrome.

Full Information

First Posted
January 6, 2014
Last Updated
March 25, 2018
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Onze Lieve Vrouwe Gasthuis, Diakonessenhuis, Utrecht, Elkerliek Hospital, Groene Hart Ziekenhuis, Dijklander Ziekenhuis, Reinier de Graaf Groep, Maasstad Hospital, BovenIJ Hospital, Rijnland Hospital, Flevoziekenhuis, Radboud University Medical Center, Maxima Medical Center, Zaans Medisch Centrum
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1. Study Identification

Unique Protocol Identification Number
NCT02030496
Brief Title
Volar Internal Plate Fixation vs. Plaster in Extra- Articular Distal Radial Fractures
Acronym
VIPER
Official Title
Volar Internal Plate Fixation vs. Plaster in Extra- Articular Distal Radial Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Onze Lieve Vrouwe Gasthuis, Diakonessenhuis, Utrecht, Elkerliek Hospital, Groene Hart Ziekenhuis, Dijklander Ziekenhuis, Reinier de Graaf Groep, Maasstad Hospital, BovenIJ Hospital, Rijnland Hospital, Flevoziekenhuis, Radboud University Medical Center, Maxima Medical Center, Zaans Medisch Centrum

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
BACKGROUND: Fractures of the distal radius are common and account for an estimated 17% of all fractures diagnosed. Two-thirds of these fractures are displaced and require reduction. Although distal radius fractures are considered to be relatively harmless, inadequate treatment may result in impaired function of the wrist. The consequences of post-traumatic loss of function are comprehensive, both on an individual and a social level, and have long been underestimated. Despite the substantial implications, no evidence-based treatment method yet exists. Good results have been described both in patients treated conservatively and surgically. Nevertheless, 60% of all fractures redislocate after conservative treatment at which point surgical reduction and fixation is the treatment of choice. Recently, the use of volar locking plates has become more popular. This type of osteosynthesis employs a volar approach to the wrist and provides immediate stable fixation of the reduced fracture. This stability allows for early mobilisation and may therefore result in an improved regain of function. The aim of this study is to compare the functional outcome following surgical reduction and fixation with a volar locking plate with the functional outcome following closed reduction and plaster immobilisation at one year follow-up in patients with displaced extra-articular distal radius fractures. DESIGN: This single blinded randomised controlled trial will randomise between open reduction and internal fixation with a volar locking plate (intervention group) and closed reduction followed by plaster immobilisation (control group). The study population will consist of all consecutive adult patients who are diagnosed with a displaced extra-articular distal radius fracture which has been adequately reduced at the Emergency Department. The primary outcome (functional outcome) will be assessed by means of the Disability Arm Shoulder Hand Score (DASH). Since the treatment allocated involves a surgical procedure, randomisation status will not be blinded. However, the researcher assessing the outcome at one year will be unaware of the treatment allocation. In total, 90 patients will be included in this trial which will be conducted in the Academic Medical Centre Amsterdam and its partners of the regional trauma care network.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Displaced Extra-articular Distal Radius Fractures
Keywords
distal radius fractures, Closed reduction, Open reduction internal fixation, Volar plate, Redislocation, Unstable fracture, Extra-articular fracture, Colles fracture, Barton fracture

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Closed reduction and plaster
Arm Type
Active Comparator
Arm Description
Closed reduction will be performed and after adequate reduction has been confirmed, the wrist will be immobilised according to Dutch guidelines: a splint for one week followed by a circular cast for another four weeks.
Arm Title
open reduction and internal fixation
Arm Type
Active Comparator
Arm Description
The intervention group will be treated with open reduction and internal fixation with a volar locking plate.
Intervention Type
Procedure
Intervention Name(s)
open reduction and internal fixation
Intervention Description
The surgery will be performed by a certified trauma surgeon. After the fracture site is exposed, the fracture will be reduced and provisionally fixed with K-Wires and reduction forceps. An appropriate volar locking plate which best suits the anatomy of the wrist and the fracture type will be selected. Screw placement and fracture reduction will be confirmed intra-operatively by radiographic images. No post-operative fixation will be applied and patients will be instructed to use the affected extremity in daily activities as pain allows. According to Dutch treatment standards, vitamin C 500 milligrams will be prescribed to all patients at initial presentation and for a duration of two months in order to prevent Complex Regional Pain Syndrome.
Intervention Type
Other
Intervention Name(s)
Closed reduction and plaster
Intervention Description
Closed reduction will be performed according to the Robert-Jones method. This involves increasing the deformity first, then applying continuous traction and immobilising wrist and hand in the reduced position. Additional radiographs will be performed to verify the quality of the reduction. After this has been confirmed, the wrist will be immobilised according to Dutch guidelines: a splint for one week followed by a circular cast for another four weeks. According to Dutch treatment standards, vitamin C 500 milligrams will be prescribed to all patients at initial presentation and for a duration of two months in order to prevent Complex Regional Pain Syndrome.
Primary Outcome Measure Information:
Title
Wrist function/pain/disability at one year assessed with DASH score
Description
the primary endpoint of this study is wrist function, pain and disability as measured with the DASH score. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb.
Time Frame
At12 months follow up
Secondary Outcome Measure Information:
Title
Wrist function at one year assessed with PRWE score
Description
The PRWE questionnaire is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of three subscales: Pain, Function and Cosmetics.
Time Frame
6 weeks, three, six and 12 months
Title
Quality of Life
Description
Quality of Life assessed using the Short Form-36 (SF-36) questionnaire. The SF-36 is a validated multipurpose, short form health survey which contains 36 questions representing eight different health domains. These domains are combined into a mental and physical component scale. From each domain, scores ranging from 0 to 100 points are derived, with lower scores indicating poorer quality of life.
Time Frame
6 weeks, three, six and 12 months
Title
Pain
Description
Pain as indicated on a visual Analogue Scale (VAS), in which 0 implies no pain and 10 the worst possible pain. Patients will be asked to give an estimation of the type and quantity of pain medication taken during all follow-up visits.
Time Frame
6 weeks, 3, 6 and 12 months
Title
Patient satisfaction
Description
Patient satisfaction at one year by simply asking patients if they are satisfied with the result (yes/no).
Time Frame
at one year
Title
Range of motion
Description
Range of motion of the wrist measured on both sides with a handheld goniometer.
Time Frame
6 weeks, 3, 6 and 12 months
Title
Grip strength
Description
Grip strength as measured with a dynamometer.
Time Frame
6 weeks, 3, 6 and 12 months
Title
Radiological parameters
Description
Radiological parameters: radial inclination, volar/dorsal tilt, comminution, ulnar variance and radial length measured digitally in the Picture Archiving and Communication System (PACS) on standard posterior anterior (PA), lateral carporadial and lateral X-rays of the wrist. Radiographs will be obtained according to standardised procedures. PA radiographs with the shoulder in 90 degrees abduction, elbow in 90 degrees flexion and the wrist in neutral position; lateral X-rays with the shoulder in neutral position and elbow in 90 degrees flexion; and the lateral carporadial radiographs will be obtained by positioning the lower arm on a 20-25 degrees angled wedge.
Time Frame
At one year
Title
Complications
Description
Complication rate such as: loss of reduction, cross-overs from conservative to operative treatment, fracture malunion or non-union, wound and/or plate infection, tendon irritation and/or rupture, neuropathy and the occurrence of complex regional pain syndrome.
Time Frame
1 week, 2-3 weeks, 6 weeks, 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients ≥ 18 years and ≤ 75 years Extra-articular (AO type A) displaced distal radius fracture, as classified on lateral, posterior anterior and lateral carporadial radiographs by a radiologist or trauma surgeon. Acceptable closed reduction obtained according to current Dutch guidelines within 12 hours after presentation at the Emergency Department (ED). Exclusion Criteria: Open distal radius fractures Multiple trauma patients (Injury Severity Score (ISS) ≥16) Other fractures of the affected extremity Patients with impaired wrist function prior to injury due to arthritis/neurological disorders of the upper limb Patient suffering from disorders of bone metabolism, connective tissue or (joint) hyperflexibility. Insufficient comprehension of the Dutch language to understand the treatment information and informed consent forms as judged by the attending physician.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Carel Goslings, MD, PhD
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105AZ
Country
Netherlands

12. IPD Sharing Statement

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Volar Internal Plate Fixation vs. Plaster in Extra- Articular Distal Radial Fractures

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