Distal Radius FractureNCT01904084
Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture
A study testing Volar locked plating and Hoffman external fixator in people with Distal Radius Fracture, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to evaluate function, pain and radiographic evaluation in patients treated with volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular distal radius fractures, AO/OTA type A Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Volar locked plating and Hoffman external fixator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2013to May 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with dislocated extraarticular distal radius fracture age 18-70 years
Who cannot join
- Cognitively impaired
- Drug abuse
- Congenital bone disease
- Earlier wrist injury
- Open fracture, Gustilo-Anderson type 3
- Pathological fractures( except osteoporotic fractures)
- Tourists
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Prospective Comparison of Volar Locked Plating Versus Hoffman II Bridging External Fixation in Patients With Dislocated Distal Radius Fractures, AO/OTA Type A.
The purpose of this study is to evaluate function, pain and radiographic evaluation in patients treated with volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular distal radius fractures, AO/OTA type A
Read the detailed description
We have designed a randomized prospective study for comparison of volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular dislocated distal radius fractures AO/OTA type A3. On the basis of power analysis a total of 160 patients are to be included in this project. The follow-up period is 1 year and evaluation is based on x-ray analysis, grip strength, range of motion, pain and satisfaction with the treatment ( PRWE, Quick-DASH)
- Conditions
- Distal Radius Fracture
- Being tested
- Volar locked plating, Hoffman external fixator
- Keywords
- Distal radius fracture
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volar locked platingDevice
Also called DVR Anatomic plate, Hand Innovations, De Puy
Operative treatment of distal radius fracture with volar locking plate
Hoffman external fixatorDevice
Also called Bridging Hoffman II Compact, Stryker
Patients with distal radius fracture operated with Hoffman external fixator
| Study group | Role | What they receive |
|---|---|---|
| Volar locked plating | Active comparator | One group with distal radius fracture is operated with Locking plate Receives: Device: Volar locked plating |
| Hoffman external fixator | Active comparator | One group with distal radius fracture is operated with Hoffman external fixator Receives: Device: Hoffman external fixator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient rated wrist evaluation (PRWE)score
Measured: 3 months
Patient rated wrist evaluation (PRWE)score
Measured: 6 weeks
Patient rated wrist evaluation (PRWE)score
Measured: 12 months
Secondary outcomes (4)
Quick-DASH score
Measured: 6 weeks, 3 and 12 months
Pain VAS-score
Measured: 6 weeks, 3 and 12 months
Complications
Number of patients with per- and postoperative complications will be registrated. Types of expected complications: Tendon rupture, Tendon irritation, Carpal Tunnel Syndrome, Complex Regional Pain Syndrome, Screw displacement/screw loosening, Delayed fracture union
Measured: 6 weeks, 3 and 12 months
Radiographic evaluation
Palmar tilt, Radial inclination, Ulnar variance, Fracture union
Measured: 6 weeks 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 posted22 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse-Bergen HF
- Responsible party
- Sponsor
- Investigators
- Trine Ludvigsen, Md, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904084
- Sponsor's protocol ID
- 2013/555
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2013
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Esposito J, Schemitsch EH, Saccone M, Sternheim A, Kuzyk PR. External fixation versus open reduction with plate fixation for distal radius fractures: a meta-analysis of randomised controlled trials. Injury. 2013 Apr;44(4):409-16. doi: 10.1016/j.injury.2012.12.003. Epub 2013 Jan 6.
PubMed 23298757Ludvigsen T, Matre K, Vetti N, Kristoffersen PM, Toppe MK, Gudmundsdottir R, Krukhaug Y, Dybvik E, Fevang JM. Is there a correlation between functional results and radiographic findings in patients with distal radius fracture A0 type A3 treated with volar locking plate or external fixator? OTA Int. 2021 Aug 9;4(3):e142. doi: 10.1097/OI9.0000000000000142. eCollection 2021 Sep.
PubMed 34746674
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Comparison of Volar Locked Plating Versus Hoffman II Bridging External Fixation in Patients With Dislocated Distal Radius Fractures, AO/OTA Type A.
- ClinicalTrials.gov ID
- NCT01904084
- Acronym / sponsor ID
- 2013/555
- Conditions
- Distal Radius Fracture
- Keywords
- Distal radius fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Helse-Bergen HF
- Study start
- Aug 2013
- Primary completion
- May 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 22 Jul 2013 (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.
The purpose of this study is to evaluate function, pain and radiographic evaluation in patients treated with volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular distal radius fractures, AO/OTA type A
Detailed description
We have designed a randomized prospective study for comparison of volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular dislocated distal radius fractures AO/OTA type A3. On the basis of power analysis a total of 160 patients are to be included in this project. The follow-up period is 1 year and evaluation is based on x-ray analysis, grip strength, range of motion, pain and satisfaction with the treatment ( PRWE, Quick-DASH)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volar locked plating | Active comparator | Device: Volar locked platingOne group with distal radius fracture is operated with Locking plate |
| Hoffman external fixator | Active comparator | Device: Hoffman external fixatorOne group with distal radius fracture is operated with Hoffman external fixator |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with dislocated extraarticular distal radius fracture age 18-70 years
Key exclusion criteria (7 listed)
- Cognitively impaired
- Drug abuse
- Congenital bone disease
- Earlier wrist injury
- Open fracture, Gustilo-Anderson type 3
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 |
|---|---|---|
| Volar locked platingAlso: DVR Anatomic plate, Hand Innovations, De PuyOperative treatment of distal radius fracture with volar locking plate | Device | Volar locked plating |
| Hoffman external fixatorAlso: Bridging Hoffman II Compact, StrykerPatients with distal radius fracture operated with Hoffman external fixator | Device | Hoffman external fixator |
Primary outcome
Patient rated wrist evaluation (PRWE)score
Time frame: 3 months
Patient rated wrist evaluation (PRWE)score
Time frame: 6 weeks
Patient rated wrist evaluation (PRWE)score
Time frame: 12 months
4 secondary outcomes
Quick-DASH score
Time frame: 6 weeks, 3 and 12 months
Pain VAS-score
Time frame: 6 weeks, 3 and 12 months
Complications
Time frame: 6 weeks, 3 and 12 months
Radiographic evaluation
Time frame: 6 weeks 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 28 Aug 2019.
- Background: PubMed 23298757Esposito J, Schemitsch EH, Saccone M, Sternheim A, Kuzyk PR. External fixation versus open reduction with plate fixation for distal radius fractures: a meta-analysis of randomised controlled trials. Injury. 2013 Apr;44(4):409-16. doi: 10.1016/j.injury.2012.12.003. Epub 2013 Jan 6.
- Derived from this study: PubMed 34746674Ludvigsen T, Matre K, Vetti N, Kristoffersen PM, Toppe MK, Gudmundsdottir R, Krukhaug Y, Dybvik E, Fevang JM. Is there a correlation between functional results and radiographic findings in patients with distal radius fracture A0 type A3 treated with volar locking plate or external fixator? OTA Int. 2021 Aug 9;4(3):e142. doi: 10.1097/OI9.0000000000000142. eCollection 2021 Sep.
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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.
Trine Ludvigsen, Md principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volar locked plating and Hoffman external fixator in people with Distal Radius Fracture, run by Haukeland University Hospital at 1 site in Norway.
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 1 inclusion and 7 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 28 Aug 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 Norway. 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?
Patient rated wrist evaluation (PRWE)score (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT01904084, which also lists 2 linked publications.
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 28 Aug 2019.