Displaced Extra-articular Distal Radius FracturesVIPERNCT02030496
Volar Internal Plate Fixation vs. Plaster in Extra- Articular Distal Radial Fractures
A study testing open reduction and internal fixation and Closed reduction and plaster in people with Displaced Extra-articular Distal Radius Fractures, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Displaced Extra-articular Distal Radius Fractures
- What is being tested?
- open reduction and internal fixation and Closed reduction and plaster
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2013to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- open reduction and internal fixation, Closed reduction and plaster
- Keywords
- distal radius fractures, Closed reduction, Open reduction internal fixation, Volar plate, Redislocation, Unstable fracture, Extra-articular fracture, Colles fracture, Barton fracture
- Medical subject headings
- Wrist Fractures, Colles' Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open reduction and internal fixationProcedure or surgery
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.
Closed reduction and plasterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Closed reduction and plaster | Active comparator | 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. Receives: Other: Closed reduction and plaster |
| open reduction and internal fixation | Active comparator | The intervention group will be treated with open reduction and internal fixation with a volar locking plate. Receives: Procedure: open reduction and internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At12 months follow up
Secondary outcomes (8)
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.
Measured: 6 weeks, three, six and 12 months
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.
Measured: 6 weeks, three, six and 12 months
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.
Measured: 6 weeks, 3, 6 and 12 months
Patient satisfaction
Patient satisfaction at one year by simply asking patients if they are satisfied with the result (yes/no).
Measured: at one year
Range of motion
Range of motion of the wrist measured on both sides with a handheld goniometer.
Measured: 6 weeks, 3, 6 and 12 months
Grip strength
Grip strength as measured with a dynamometer.
Measured: 6 weeks, 3, 6 and 12 months
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.
Measured: At one year
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.
Measured: 1 week, 2-3 weeks, 6 weeks, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionMar 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Displaced Extra-articular Distal Radius FracturesStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, J.C. Goslings, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- J. Carel Goslings, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030496
- Sponsor's protocol ID
- NL37754.018.12
- Acronym
- VIPER
- Status last verified
- Mar 2018
- First submitted
- 6 Jan 2014
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volar Internal Plate Fixation vs. Plaster in Extra- Articular Distal Radial Fractures
- ClinicalTrials.gov ID
- NCT02030496
- Acronym / sponsor ID
- VIPER / NL37754.018.12
- Keywords
- distal radius fractures, Closed reduction, Open reduction internal fixation, Volar plate, Redislocation, Unstable fracture, Extra-articular fracture, Colles fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- 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
- Study start
- Jan 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed reduction and plaster | Active comparator | Other: Closed reduction and plasterClosed 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. |
| open reduction and internal fixation | Active comparator | Procedure: open reduction and internal fixationThe intervention group will be treated with open reduction and internal fixation with a volar locking plate. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| open reduction and internal fixationThe 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. | Procedure or surgery | open reduction and internal fixation |
| Closed reduction and plasterClosed 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. | Other | Closed reduction and plaster |
Primary outcome
Wrist function/pain/disability at one year assessed with DASH score
Time frame: At12 months follow up
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.
8 secondary outcomes
Wrist function at one year assessed with PRWE score
Time frame: 6 weeks, three, six and 12 months
Quality of Life
Time frame: 6 weeks, three, six and 12 months
Pain
Time frame: 6 weeks, 3, 6 and 12 months
Patient satisfaction
Time frame: at one year
Range of motion
Time frame: 6 weeks, 3, 6 and 12 months
Grip strength
Time frame: 6 weeks, 3, 6 and 12 months
Radiological parameters
Time frame: At one year
Complications
Time frame: 1 week, 2-3 weeks, 6 weeks, 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Carel Goslings, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open reduction and internal fixation and Closed reduction and plaster in people with Displaced Extra-articular Distal Radius Fractures, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrist function/pain/disability at one year assessed with DASH score (time frame: At12 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.