Distal Radius FractureREDIRANCT06011122
Analysis of Implant Placement in Patients With Distal Radius Fractures in Western Brittany (REDIRA)
An observational study of Distal Radius Fracture, run by University Hospital, Brest at 5 sites in France.
Trial summary
The purpose of this study was to determine the impact of design on plate position at the level of the distal radius. Six anterior wrist plates design were analyzed relative to the watershed line using the Soong classification. Read more about this study
- Who is it for?
- Ages 14 to 102 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Distal radius fracture ORIF with a specific volar plate
- Type of treatment
- Surgery or procedure
- How many people
- 2,723 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Mar 2022to 4 Apr 2022
- 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 14 to 102 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We included all patients with an intra-articular or extra-articular distal radial fracture managed by Volar Locking Plate fixation.
Who may be able to join
None listed.
Who cannot join
- Patient refusal No postoperative radiograph N=40 Poor quality radiograph N=214
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
HIA Brest
Brest, 29600
CHRU de brest
Brest, 29609
CH de Landerneau
Landerneau, 29
CH des pays de Morlaix
Morlaix, 29249
CHIC de Quimper
Quimper, 29000
About this study
Official title: Analysis of Implant Placement of Patients With Distal Radius Fractures in Western Britain,
The purpose of this study was to determine the impact of design on plate position at the level of the distal radius. Six anterior wrist plates design were analyzed relative to the watershed line using the Soong classification. A total of 2723 anterior locking plate fixation cases were analyzed and divided into six groups: Zimmer Biomet, Newclip Technics, Stryker, Synthes, Medartis and Medartis Footprint. The number of plates recorded as Soong grade 0+1 was determined for each design, then compared using the Marascuilo procedure. The Zimmer Biomet and Newclip plates were proximal to the Watershed line significantly more often than those by Synthes and Medartis Footprint. Plate position with the Medartis design was significantly more proximal to the Watershed line compared to its companion design, the Medartis Footprint plate. Plate design is a deciding factor when treating distal radial fractures, to avoid impingement when implant removal is not routinely planned.
Read the detailed description
This is a retrospective multicenter study involving several orthopedic surgeons with a trauma surgery practice within the public hospital centers of the department of Finistère. These include the CHU de Brest - Brest University Hospital Center (La Cavale Blanche), the HIA Clermont-Tonnerre military hospital (Hôpital d'Instruction des Armées - Armed Forces Teaching Hospital), the CH des Pays de Morlaix, the CH de Landerneau Ferdinand Grall, the CH de Carhaix and the CH de Cornouaille Quimper Concarneau. This study was approved by the local ethics committee. Among the cited hospital centers, the CHU de Brest is a level 1 trauma center, the CH des pays de Morlaix, the HIA military hospital and the CH de Cornouaille are level 2 trauma centers and the CH de Landerneau and Carhaix are level 3 trauma centers.
- Conditions
- Distal Radius Fracture
- Being tested
- Distal radius fracture ORIF with a specific volar plate
- Keywords
- Distal Radius fracture, Volar plate, Plate design, Watershed line, Plate positioning
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal radius fracture ORIF with a specific volar plateProcedure or surgery
Patients who had a distal radius fracture were treated surgically : an ORIF was realised with a volar plate
| Study group | Role | What they receive |
|---|---|---|
| Zimmer Biomet | Patients who were operated with a Zimmer Biomet plate Receives: Procedure: Distal radius fracture ORIF with a specific volar plate | |
| Newclip Technics | Patients who were operated with a Newclip Technics plate Receives: Procedure: Distal radius fracture ORIF with a specific volar plate | |
| Stryker | Patients who were operated with a Stryker plate Receives: Procedure: Distal radius fracture ORIF with a specific volar plate | |
| Medartis | Patients who were operated with a Medartis plate Receives: Procedure: Distal radius fracture ORIF with a specific volar plate | |
| Medartis Footprint | Patients who were operated with a Medartis Footprint plate Receives: Procedure: Distal radius fracture ORIF with a specific volar plate | |
| Synthes | Patients who were operated with a Synthes plate Receives: Procedure: Distal radius fracture ORIF with a specific volar plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of plate design on positioning
The primary aim of this study was to compare six different VLPs meant to be positioned proximal to the watershed line, using the Soong classification.
We will assess the rate of plates positioned "Soong 0+1" for each plate design
Measured: Retrospective study on Xray during 45 days
Secondary outcomes (2)
Epidemiology
to study the epidemiology of VLP fixation, per year, as recorded by the department of Finistère (northwestern France).
We will assess for every year between 2009 and 2020 the prevalence of distal fracture treated by the use of a volar plate.
Measured: Retrospective study on Xray during 45 days
Impact of fracture type on plate positioning
determine whether the type of fracture has an impact on plate position as defined by the Soong classification. We will assess the rates of different types of fractures according to AO classification and the rate of plates "Soong 0+1" for each fracture type
Measured: Retrospective study on Xray during 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Mar 2022
- Primary completion1 Apr 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,723 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hoel Letissier, MD MSc, Principal investigator, Brest UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011122
- Sponsor's protocol ID
- 29BRC21.0084 - REDIRA
- Acronym
- REDIRA
- Status last verified
- Aug 2023
- First submitted
- 7 Jan 2022
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Implant Placement of Patients With Distal Radius Fractures in Western Britain,
- ClinicalTrials.gov ID
- NCT06011122
- Acronym / sponsor ID
- REDIRA / 29BRC21.0084 - REDIRA
- Conditions
- Distal Radius Fracture
- Keywords
- Distal Radius fracture, Volar plate, Plate design, Watershed line, Plate positioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,723 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 25 Aug 2023 (actual)
- 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 was to determine the impact of design on plate position at the level of the distal radius. Six anterior wrist plates design were analyzed relative to the watershed line using the Soong classification. A total of 2723 anterior locking plate fixation cases were analyzed and divided into six groups: Zimmer Biomet, Newclip Technics, Stryker, Synthes, Medartis and Medartis Footprint. The number of plates recorded as Soong grade 0+1 was determined for each design, then compared using the Marascuilo procedure. The Zimmer Biomet and Newclip plates were proximal to the Watershed line significantly more often than those by Synthes and Medartis Footprint. Plate position with the Medartis design was significantly more proximal to the Watershed line compared to its companion design, the Medartis Footprint plate. Plate design is a deciding factor when treating distal radial fractures, to avoid impingement when implant removal is not routinely planned.
Detailed description
This is a retrospective multicenter study involving several orthopedic surgeons with a trauma surgery practice within the public hospital centers of the department of Finistère. These include the CHU de Brest - Brest University Hospital Center (La Cavale Blanche), the HIA Clermont-Tonnerre military hospital (Hôpital d'Instruction des Armées - Armed Forces Teaching Hospital), the CH des Pays de Morlaix, the CH de Landerneau Ferdinand Grall, the CH de Carhaix and the CH de Cornouaille Quimper Concarneau. This study was approved by the local ethics committee. Among the cited hospital centers, the CHU de Brest is a level 1 trauma center, the CH des pays de Morlaix, the HIA military hospital and the CH de Cornouaille are level 2 trauma centers and the CH de Landerneau and Carhaix are level 3 trauma centers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Zimmer Biomet | – | Procedure: Distal radius fracture ORIF with a specific volar platePatients who were operated with a Zimmer Biomet plate |
| Newclip Technics | – | Procedure: Distal radius fracture ORIF with a specific volar platePatients who were operated with a Newclip Technics plate |
| Stryker | – | Procedure: Distal radius fracture ORIF with a specific volar platePatients who were operated with a Stryker plate |
| Medartis | – | Procedure: Distal radius fracture ORIF with a specific volar platePatients who were operated with a Medartis plate |
| Medartis Footprint | – | Procedure: Distal radius fracture ORIF with a specific volar platePatients who were operated with a Medartis Footprint plate |
| Synthes | – | Procedure: Distal radius fracture ORIF with a specific volar platePatients who were operated with a Synthes plate |
Who may qualify
- Ages
- 14 to 102 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We included all patients with an intra-articular or extra-articular distal radial fracture managed by Volar Locking Plate fixation.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patient refusal No postoperative radiograph N=40 Poor quality radiograph N=214
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 |
|---|---|---|
| Distal radius fracture ORIF with a specific volar platePatients who had a distal radius fracture were treated surgically : an ORIF was realised with a volar plate | Procedure or surgery | Medartis, Medartis Footprint, Newclip Technics, Stryker, Synthes, Zimmer Biomet |
Primary outcome
Influence of plate design on positioning
Time frame: Retrospective study on Xray during 45 days
The primary aim of this study was to compare six different VLPs meant to be positioned proximal to the watershed line, using the Soong classification. We will assess the rate of plates positioned "Soong 0+1" for each plate design
2 secondary outcomes
Epidemiology
Time frame: Retrospective study on Xray during 45 days
Impact of fracture type on plate positioning
Time frame: Retrospective study on Xray during 45 days
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 25 Aug 2023.
- Jerrhag D, Englund M, Karlsson MK, Rosengren BE. Epidemiology and time trends of distal forearm fractures in adults - a study of 11.2 million person-years in Sweden. BMC Musculoskelet DisordLink provided by the sponsor.
- The Epidemiology of Upper Extremity Fractures in the United States, 2009. J Orthop Trauma 2015;29:e242-244Link provided by the sponsor.
- Corsino CB, Reeves RA, Sieg RN. Distal Radius Fractures. StatPearls, Treasure Island (FL)Link provided by the sponsor.
- Fractures of the distal part of the radius. The evolution of practice over time. Where's the evidence?Link provided by the sponsor.
- Brehmer JL, Husband JB. Accelerated rehabilitation compared with a standard protocol after distal radial fractures treated with volar open reduction and internal fixation: a prospective, randomized, controlled studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Distal Radius Fracture
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
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.
Hoel Letissier, MD MSc principal investigator
Brest UH
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fracture, run by University Hospital, Brest at 5 sites in France.
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 0 inclusion and 1 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 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
Influence of plate design on positioning (time frame: Retrospective study on Xray during 45 days). 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 25 Aug 2023.