Distal Radial Fractures Treated With a DVR-A Locking PlateNCT01122628
Long Term Follow up of the DVR-A Locking Plate
An observational study of Distal Radial Fractures Treated With a DVR-A Locking Plate, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The surgical treatment of wrist fractures (distal radius bone) has been changed by the introduction of a new plate design, the locking plate. This results in improved fixation and stabilisation of the fracture fragments allowing early movement. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Distal Radial Fractures Treated With a DVR-A Locking Plate
- What is being tested?
- ORIF with DVR-A locking plate
- Type of treatment
- Medical device
- How many people
- 136 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2010to Oct 2012
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be taken from a population consisting of all patients who have undergone distal radial fracture treatement with a DVR-A locking plate at the norfolk and Norwich University hospitals NHS Foundation Trust
Who may be able to join
- Treatment between Jan 2005 and March 2009
Who cannot join
- Under 16
- Unable to consent
- Pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
About this study
Official title: Long Term Follow Up Study Into The Use Of The DVR-A Locking Plate In The Treatment Of Distal Radial Fractures
The surgical treatment of wrist fractures (distal radius bone) has been changed by the introduction of a new plate design, the locking plate. This results in improved fixation and stabilisation of the fracture fragments allowing early movement.
This type of plate has been increasingly used throughout the world but questions have been raised regarding the potential complications of the surgery, particularly nerve and tendon injury. The Norfolk and Norwich Hospital has treated over 250 distal radial fractures with this type of plate. The investigators plan to recall these patients to asses their long term function, general satisfaction and radiological results.
- Being tested
- ORIF with DVR-A locking plate
- Keywords
- Distal Radial Fracture, Volar Locking Plate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIF with DVR-A locking plateDevice
Also called Distal volar radial anatomic plate, Hand inovations
Size, length of plate and number os screws decided by operating surgeon
| Study group | Role | What they receive |
|---|---|---|
| DVR-A | Patients with a distal radial fracture treated with a DVR-A locking plate Receives: Device: ORIF with DVR-A locking plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH score
Disability of arm shoulder and hand score. This is a patient administered validated score
Measured: One year or more post surgery
Pain
A patient administered visual analogue scale numbered 1-10. A mark can be placed anywhere along the line with a score of 0 indicating no pain and 10 the worst pain imaginable
Measured: One year or more post surgery
Secondary outcomes (6)
Complications
Examination and questioning by a hand therapist to pick up complications. Prompting for tendon irritation or rupture, neurovascular injury, plate or screw failure, hardware removal and infection
Measured: One year or more post surgery
Radiographic appearance
Review of xrays to measure radial inclination, volar tilt,, shortening, articular stepoff and degenerative change
Measured: One year or more post surgery
EQ 5D
Euroqual 5D is a patient administered general health questionaire that is validated.
Measured: More than one year post surgery
Grip Strength
Measured by a dynomometer and referenced to the non operated side
Measured: One year or more post surgery
Range of motion
Measured with a goniometer. Measurements taken of movements in the axial,coronal and sagital planes
Measured: One year or more post surgery
Pain
A patient administered visual analogue scale numbered 1-10. A mark can be placed anywhere along the line with a score of 0 indicating no pain and 10 the worst pain imaginable
Measured: One year or more post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radial Fractures Treated With a DVR-A Locking PlateStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy International, Global Diagnostics UK
- Responsible party
- Sponsor
- Investigators
- Adrian J Chojnowski, Principal investigator, Norfolk and Norwich University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122628
- Sponsor's protocol ID
- 2009ORTH11
- Other IDs
- ISS2009050
- Status last verified
- Aug 2018
- First submitted
- 12 May 2010
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow Up Study Into The Use Of The DVR-A Locking Plate In The Treatment Of Distal Radial Fractures
- ClinicalTrials.gov ID
- NCT01122628
- Acronym / sponsor ID
- 2009ORTH11
- Keywords
- Distal Radial Fracture, Volar Locking Plate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- DePuy International, Global Diagnostics UK
- Study start
- May 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 May 2010 (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 surgical treatment of wrist fractures (distal radius bone) has been changed by the introduction of a new plate design, the locking plate. This results in improved fixation and stabilisation of the fracture fragments allowing early movement.
This type of plate has been increasingly used throughout the world but questions have been raised regarding the potential complications of the surgery, particularly nerve and tendon injury. The Norfolk and Norwich Hospital has treated over 250 distal radial fractures with this type of plate. The investigators plan to recall these patients to asses their long term function, general satisfaction and radiological results.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DVR-A | – | Device: ORIF with DVR-A locking platePatients with a distal radial fracture treated with a DVR-A locking plate |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be taken from a population consisting of all patients who have undergone distal radial fracture treatement with a DVR-A locking plate at the norfolk and Norwich University hospitals NHS Foundation Trust
Key inclusion criteria (1 listed)
- Treatment between Jan 2005 and March 2009
Key exclusion criteria (3 listed)
- Under 16
- Unable to consent
- Pregnant
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 |
|---|---|---|
| ORIF with DVR-A locking plateAlso: Distal volar radial anatomic plate, Hand inovationsSize, length of plate and number os screws decided by operating surgeon | Device | DVR-A |
Primary outcome
DASH score
Time frame: One year or more post surgery
Disability of arm shoulder and hand score. This is a patient administered validated score
Pain
Time frame: One year or more post surgery
A patient administered visual analogue scale numbered 1-10. A mark can be placed anywhere along the line with a score of 0 indicating no pain and 10 the worst pain imaginable
6 secondary outcomes
Complications
Time frame: One year or more post surgery
Radiographic appearance
Time frame: One year or more post surgery
EQ 5D
Time frame: More than one year post surgery
Grip Strength
Time frame: One year or more post surgery
Range of motion
Time frame: One year or more post surgery
Pain
Time frame: One year or more post surgery
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 23 Aug 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.
Adrian J Chojnowski principal investigator
Norfolk and Norwich University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radial Fractures Treated With a DVR-A Locking Plate, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 3 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 23 Aug 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 United Kingdom. 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?
DASH score (time frame: One year or more post surgery). The study lists 2 primary outcomes in all. 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 23 Aug 2018.