Displaced Complete Articular Distal Radius FracturesVIPARNCT02651779
Internal Plate Fixation vs. Plaster in Complete Articular Distal Radial Fractures
A study testing Open reduction and internal plate fixation and Closed reduction and plasterimmobilisation in people with Displaced Complete Articular Distal Radius Fractures, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
There is no consensus about the best treatment for patients with displaced complete articular distal radius fractures (AO type C fractures). Despite this lack of consensus and the lack of available literature on comparative data to guide treatment for this patient population, operative treatment with plate fixation… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Displaced Complete Articular Distal Radius Fractures
- What is being tested?
- Open reduction and internal plate fixation and Closed reduction and plasterimmobilisation
- 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
- 19 Jun 2015to 14 Feb 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients from 18 - 75 years
- AO type C displaced distal radius fracture, as classified on lateral, posterior anterior and lateral carporadial radiographs/CT-scan by a radiologist or trauma surgeon
- Acceptable closed reduction obtained immediately after admission to the Emergency Department (<12hrs)
Who cannot join
- Patients with impaired wrist function prior to injury due to arthrosis/neurological disorders of the upper limb
- Open distal radius fractures
- Multiple trauma patients (Injury Severity Score (ISS) ≥16)
- Other fractures of the affected extremity (except from ulnar styloid process)
- Fracture of other wrist
- Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information as judged by the attending physician
- Patient suffering from disorders of bone metabolism other than osteoporosis (i.e. Paget's disease, renal osteodystrophy, osteomalacia)
- Patients suffering from connective tissue disease or (joint) hyperflexibility disorders such as Marfan's, Ehler Danlos or other related disorders
Trial locations and contacts
1 site in 1 country.
About this study
There is no consensus about the best treatment for patients with displaced complete articular distal radius fractures (AO type C fractures). Despite this lack of consensus and the lack of available literature on comparative data to guide treatment for this patient population, operative treatment with plate fixation has gained popularity. The aim of this study is to compare the functional outcome of open reduction and plate fixation with closed reduction and plaster immobilisation in adult patients (18-75 years) with displaced complete articular distal radius fractures.
Read the detailed description
Distal radius fractures account for 17% of all fractures diagnosed. Two third of those fractures are displaced and need to be reduced.
According to the Dutch National Guidelines, displaced distal radius fractures, after adequate reduction confirmed on X-ray, are best treated nonoperatively with cast immobilization. Moreover, the AAOS Clinical Practice Guideline only suggest surgical fixation when the articular step, after reduction, exceeds 2mm. However, both recommendations are based on studies who did not differentiate between intra- and extra-articular distal radius fractures. So, no clear consensus about the best treatment for patients with displaced intra-articular distal radius fractures can be made. Despite this lack of consensus and the lack of available literature on comparative data to guide treatment for this patient population, a rise in use of volar plating has been observed.
The goal of open reduction and plate fixation is to restore articular congruity and axial alignment, and to enable early post-operative movement. Several studies show good radiological and functional results using the volar locking plate in unstable displaced distal radius fractures.
No studies have been carried out to assess whether operative treatment with plate fixation is superior in displaced complete articular distal radius fractures to nonoperative treatment in patients with these fracture type. Therefore, with this randomized controlled trial the investigators wish to determine the difference in functional outcome, assessed with the Patient Related Wrist Evaluation (PRWE), after open reduction and plate fixation compared to nonoperative treatment with closed reduction and cast immobilization.
- Being tested
- Open reduction and internal plate fixation, Closed reduction and plasterimmobilisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction and internal plate fixationProcedure or surgery
Also called ORIF, Surgical treatment
Closed reduction and plasterimmobilisationOther
Also called Cast, Conservative treatment
| Study group | Role | What they receive |
|---|---|---|
| Closed reduction and plasterimmobilisation | Active comparator | The control group will be treated with closed reduction and cast immobilization. This will take place under local anaesthesia by means of a haematoma block with 20 cc Lidocaine 1%. Closed reduction will be preferably performed according to the Robert-Jones method. This involves increasing the deformity first, then applying continuous traction and immobilizing wrist and hand in the reduced position. Additional radiographs will be performed to verify the success of the reduction. After this has been confirmed, the wrist will be immobilized initially in a split plaster and later changed into a circular cast for five to six weeks immobilization in total. Receives: Other: Closed reduction and plasterimmobilisation |
| Open reduction and internal plate fixation | Other | The surgery will be performed by a certified trauma surgeon. According to the current standard treatment protocol, antibiotic prophylaxis will be administered thirty minutes preoperatively. The distal radius will be approached according to Henry, which beholds an incision between the tendon of the flexor carpi radialis muscle and the radial artery. After the fracture site is exposed, the fracture will be reduced and provisionally fixed under fluoroscopy with K-Wires/reduction forceps. An appropriate volar locking plate which best suits the anatomy of the wrist and the fracture type will be selected. Fracture reduction and screw placement will be confirmed by radiographic images. Additionally, fixation can be supported by a dorsal plate or radial column plate. This will be at discretion of the surgeon and depends on the fracture configuration and the position of the fragments. Wound closure will be performed at the discretion of the surgeon using standard techniques. Receives: Procedure: Open reduction and internal plate fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrist pain and disability measured with the Patient Rated Wrist Evaluation (PRWE)
The PRWE 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: 12 months
Secondary outcomes (8)
Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (DASH) questionnaire
The Disabilities of the Arm, Shoulder and Hand (DASH) score 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: 6 weeks and 3, 6 and 12 months
Quality of life measured with the SF-36
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 and 3, 6 and 12 months
Pain measured with the Visual Analogue Scale (VAS)
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: 1, 3 and 6 weeks and 3, 6 and 12 months
Range of motion measured with a goniometer
Range of motion of the wrist measured on both sides with a handheld goniometer in degrees. ROM includes pronation and supination, ulnar and radial deviation and palmar and dorsal flexion of the wrist.
Measured: 6 weeks and 3, 6 and 12 months
Grip strength measured with a dynamometer
Grip strength as measured with a dynamometer in kg as the mean of three measurements. Grip strength will be measured as a percentage of the uninjured side.
Measured: 6 weeks and 3, 6 and 12 months
Number of patients with loss of reduction
Radiographs will be performed to ensure that loss of reduction has not occurred. Loss of reduction is defined as <15° radial inclination, >15° of dorsal angulation or >20° of volar angulation, >3 mm shortening of ulnar variance or >2 mm of articular step-off or gap. Radial inclination, volar/dorsal tilt, ulnar variance and radial length will be measured digitally in the Picture Archiving and Communication System (PACS) on standard posterior anterior (PA), lateral carporadial and lateral X-rays of the wrist. If loss of reduction occured, operative treatment will be considered, but will be at discretion of the treating surgeon.
Measured: 1, 3 and 6 weeks and 3, 6 and 12 months
Cost-effectiveness and cost-utility measured with an economic evaluation questionnaire
Cost-effectiveness and cost-utility measured with an economic evaluation questionnaire based on the EQ-6D and the Standard Form Health and Labour questionnaire.
Measured: 6 weeks and 3, 6 and 12 months
Number of complications in both treatment groups
Number of complications in both patients treated with plasterimmobilisation and ORIF. Complications include 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, 3 and 6 weeks and 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 posted11 Jan 2016 (estimated)
- Study start19 Jun 2015
- Primary completion14 Feb 2019
- Study completion14 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Displaced Complete 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
- Dijklander Ziekenhuis, Maasstad Hospital, Maxima Medical Center, Catharina Ziekenhuis Eindhoven, Rijnland Hospital, Diakonessenhuis, Utrecht, BovenIJ Hospital, Onze Lieve Vrouwe Gasthuis, Groene Hart Ziekenhuis, Reinier de Graaf Groep, Flevoziekenhuis, Ziekenhuis Rivierenland, Radboud University Medical Center, Ziekenhuis Amstelland, Medical Center Alkmaar, Red Cross Hospital Beverwijk, Zaans Medical Center
- 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)Niels W.L. Schep, MD, PhD, MSc, Principal investigator, Maasstad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651779
- Sponsor's protocol ID
- NL51544.018.14
- Acronym
- VIPAR
- Status last verified
- Mar 2019
- First submitted
- 4 Jan 2016
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Mulders MAM, Walenkamp MMJ, Goslings JC, Schep NWL. Internal plate fixation versus plaster in displaced complete articular distal radius fractures, a randomised controlled trial. BMC Musculoskelet Disord. 2016 Feb 9;17:68. doi: 10.1186/s12891-016-0925-y.
PubMed 26860090
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Plate Fixation vs. Plaster in Complete Articular Distal Radial Fractures
- ClinicalTrials.gov ID
- NCT02651779
- Acronym / sponsor ID
- VIPAR / NL51544.018.14
- 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
- Dijklander Ziekenhuis, Maasstad Hospital, Maxima Medical Center, Catharina Ziekenhuis Eindhoven, Rijnland Hospital, Diakonessenhuis, Utrecht, BovenIJ Hospital, Onze Lieve Vrouwe Gasthuis, Groene Hart Ziekenhuis, Reinier de Graaf Groep, Flevoziekenhuis, Ziekenhuis Rivierenland, Radboud University Medical Center, Ziekenhuis Amstelland, Medical Center Alkmaar, Red Cross Hospital Beverwijk, Zaans Medical Center
- Study start
- 19 Jun 2015 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 11 Jan 2016 (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.
There is no consensus about the best treatment for patients with displaced complete articular distal radius fractures (AO type C fractures). Despite this lack of consensus and the lack of available literature on comparative data to guide treatment for this patient population, operative treatment with plate fixation has gained popularity. The aim of this study is to compare the functional outcome of open reduction and plate fixation with closed reduction and plaster immobilisation in adult patients (18-75 years) with displaced complete articular distal radius fractures.
Detailed description
Distal radius fractures account for 17% of all fractures diagnosed. Two third of those fractures are displaced and need to be reduced.
According to the Dutch National Guidelines, displaced distal radius fractures, after adequate reduction confirmed on X-ray, are best treated nonoperatively with cast immobilization. Moreover, the AAOS Clinical Practice Guideline only suggest surgical fixation when the articular step, after reduction, exceeds 2mm. However, both recommendations are based on studies who did not differentiate between intra- and extra-articular distal radius fractures. So, no clear consensus about the best treatment for patients with displaced intra-articular distal radius fractures can be made. Despite this lack of consensus and the lack of available literature on comparative data to guide treatment for this patient population, a rise in use of volar plating has been observed.
The goal of open reduction and plate fixation is to restore articular congruity and axial alignment, and to enable early post-operative movement. Several studies show good radiological and functional results using the volar locking plate in unstable displaced distal radius fractures.
No studies have been carried out to assess whether operative treatment with plate fixation is superior in displaced complete articular distal radius fractures to nonoperative treatment in patients with these fracture type. Therefore, with this randomized controlled trial the investigators wish to determine the difference in functional outcome, assessed with the Patient Related Wrist Evaluation (PRWE), after open reduction and plate fixation compared to nonoperative treatment with closed reduction and cast immobilization.
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 plasterimmobilisation | Active comparator | Other: Closed reduction and plasterimmobilisationThe control group will be treated with closed reduction and cast immobilization. This will take place under local anaesthesia by means of a haematoma block with 20 cc Lidocaine 1%. Closed reduction will be preferably performed according to the Robert-Jones method. This involves increasing the deformity first, then applying continuous traction and immobilizing wrist and hand in the reduced position. Additional radiographs will be performed to verify the success of the reduction. After this has been confirmed, the wrist will be immobilized initially in a split plaster and later changed into a circular cast for five to six weeks immobilization in total. |
| Open reduction and internal plate fixation | Other | Procedure: Open reduction and internal plate fixationThe surgery will be performed by a certified trauma surgeon. According to the current standard treatment protocol, antibiotic prophylaxis will be administered thirty minutes preoperatively. The distal radius will be approached according to Henry, which beholds an incision between the tendon of the flexor carpi radialis muscle and the radial artery. After the fracture site is exposed, the fracture will be reduced and provisionally fixed under fluoroscopy with K-Wires/reduction forceps. An appropriate volar locking plate which best suits the anatomy of the wrist and the fracture type will be selected. Fracture reduction and screw placement will be confirmed by radiographic images. Additionally, fixation can be supported by a dorsal plate or radial column plate. This will be at discretion of the surgeon and depends on the fracture configuration and the position of the fragments. Wound closure will be performed at the discretion of the surgeon using standard techniques. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients from 18 - 75 years
- AO type C displaced distal radius fracture, as classified on lateral, posterior anterior and lateral carporadial radiographs/CT-scan by a radiologist or trauma surgeon
- Acceptable closed reduction obtained immediately after admission to the Emergency Department (<12hrs)
Key exclusion criteria (8 listed)
- Patients with impaired wrist function prior to injury due to arthrosis/neurological disorders of the upper limb
- Open distal radius fractures
- Multiple trauma patients (Injury Severity Score (ISS) ≥16)
- Other fractures of the affected extremity (except from ulnar styloid process)
- Fracture of other wrist
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 plate fixationAlso: ORIF, Surgical treatment | Procedure or surgery | Open reduction and internal plate fixation |
| Closed reduction and plasterimmobilisationAlso: Cast, Conservative treatment | Other | Closed reduction and plasterimmobilisation |
Primary outcome
Wrist pain and disability measured with the Patient Rated Wrist Evaluation (PRWE)
Time frame: 12 months
The PRWE 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.
8 secondary outcomes
Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: 6 weeks and 3, 6 and 12 months
Quality of life measured with the SF-36
Time frame: 6 weeks and 3, 6 and 12 months
Pain measured with the Visual Analogue Scale (VAS)
Time frame: 1, 3 and 6 weeks and 3, 6 and 12 months
Range of motion measured with a goniometer
Time frame: 6 weeks and 3, 6 and 12 months
Grip strength measured with a dynamometer
Time frame: 6 weeks and 3, 6 and 12 months
Number of patients with loss of reduction
Time frame: 1, 3 and 6 weeks and 3, 6 and 12 months
Cost-effectiveness and cost-utility measured with an economic evaluation questionnaire
Time frame: 6 weeks and 3, 6 and 12 months
Number of complications in both treatment groups
Time frame: 1, 3 and 6 weeks and 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 8 Mar 2019.
- Derived from this study: PubMed 26860090Mulders MAM, Walenkamp MMJ, Goslings JC, Schep NWL. Internal plate fixation versus plaster in displaced complete articular distal radius fractures, a randomised controlled trial. BMC Musculoskelet Disord. 2016 Feb 9;17:68. doi: 10.1186/s12891-016-0925-y.
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)
Niels W.L. Schep, MD, PhD, MSc principal investigator
Maasstad Hospital
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 plate fixation and Closed reduction and plasterimmobilisation in people with Displaced Complete 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 8 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 8 Mar 2019. 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 pain and disability measured with the Patient Rated Wrist Evaluation (PRWE) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02651779, which also lists 1 linked publication.
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 8 Mar 2019.