Distal Radius FractureNCT04653051
PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System
An observational study of Distal Radius Fracture and Distal Ulna Fracture, run by Zimmer Biomet at 1 site in United Kingdom.
Trial summary
The study is a single-center, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the DVR Plates. The primary objective is the assessment of performance by analyzing fracture healing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Distal Radius Fracture, Distal Ulna Fracture, Osteotomy
- How many people
- 111 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Mar 2021to 15 Nov 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients must have received one of the DVR Plates and who meet all of the inclusion and none of the exclusion criteria.
Who may be able to join
- All subjects must have been implanted with one of the DVR Plates according to the approved indications.
Who cannot join
- Off-label use.
- Cases where there is an active infection.
- Conditions which tend to retard healing such as, blood supply limitations, previous infections, etc.
- Insufficient quantity or quality of bone to permit stabilization of the fracture.
- Conditions that restrict the patient's ability or willingness to follow postoperative instructions during the healing process.
- Foreign body sensitivity - where material sensitivity is suspected, appropriate tests should be conducted and sensitivity ruled out prior to implantations.
- Cases where the implant(s) would cross open epiphyseal plates in skeletally immature patients.
- Cases with malignant primary or metastatic tumors which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the DVR Plating System (Implant and Instrumentation) - A Retrospective Consecutive Series Study
The study is a single-center, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the DVR Plates. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objective is the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Patients' outcomes will also be assessed.
Read the detailed description
The DVR plating system in this study includes the DVR Crosslock Distal Radial Plate, the DVR Volar Rim Plate and the DVR Wrist Plates.
One site will be involved in this study. The aim is to include a total of 112 consecutive series patients treated between 2014 and 2018. All potential study subjects will be required to participate in the Informed Consent Process.
Baseline data from the preop, intraop, immediate post-op and last consultation visit will be available in medical notes and collected retrospectively. During a follow up phone call the patient will be asked to complete a patient questionnaire and a question on his/her wrist function. In addition, any complications since the last consultation visit at the clinic, information about and treatment of the complications will also be collected over the phone.
- Conditions
- Distal Radius Fracture, Distal Ulna Fracture, Osteotomy
- Keywords
- Medical Device, Performance, Safety, Clinical Benefits, Post-Market Clinical Follow-Up Study
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who received DVR Plating System | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture Healing Based on Clinical Measures and X-rays
Fracture healing will be evaluated by x-rays and clinical measures (no pain at fracture site)
Measured: Mean time of 3.8 years after the surgery
Secondary outcomes (2)
Product Safety Based on Complications
Safety will be assessed by recording and analyzing the incidence and frequency of complications. The complications are classified per ISO 14155 Definitions: Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs).
.
Measured: Mean time of 3.8 years after surgery
Patient's Outcomes Were Also Assessed
Patients were asked to complete a patient questionnaire (Patient-Rated Wrist Evaluation Score- PRWE)* and a question on their wrist function**
- the PRWE is a self-administered, patient-specific questionnaire that consists of 15 items. It was designed to measure wrist pain and disability in activities of daily living, and consists of two subscales: pain and function. A score of 100 represents the worst functional score, whereas 0 represents no disability
** Patient reported outcome: assessment of fractured wrist comparing to before injury on a scale from 0 to 10, 0 being worst imaginable, and 10 being as good as before the injury.
Measured: Mean time of 3.8 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start12 Mar 2021
- Primary completion3 Oct 2021
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan Achakri, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653051
- Sponsor's protocol ID
- MDRG2017-89MS-14T
- Status last verified
- Sep 2024
- First submitted
- 19 Nov 2020
- Last updated
- 20 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the DVR Plating System (Implant and Instrumentation) - A Retrospective Consecutive Series Study
- ClinicalTrials.gov ID
- NCT04653051
- Acronym / sponsor ID
- MDRG2017-89MS-14T
- Conditions
- Distal Radius Fracture, Distal Ulna Fracture, Osteotomy
- Keywords
- Medical Device, Performance, Safety, Clinical Benefits, Post-Market Clinical Follow-Up Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 3 Oct 2021 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Posted 20 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a single-center, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the DVR Plates. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objective is the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Patients' outcomes will also be assessed.
Detailed description
The DVR plating system in this study includes the DVR Crosslock Distal Radial Plate, the DVR Volar Rim Plate and the DVR Wrist Plates.
One site will be involved in this study. The aim is to include a total of 112 consecutive series patients treated between 2014 and 2018. All potential study subjects will be required to participate in the Informed Consent Process.
Baseline data from the preop, intraop, immediate post-op and last consultation visit will be available in medical notes and collected retrospectively. During a follow up phone call the patient will be asked to complete a patient questionnaire and a question on his/her wrist function. In addition, any complications since the last consultation visit at the clinic, information about and treatment of the complications will also be collected over the phone.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who received DVR Plating System | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients must have received one of the DVR Plates and who meet all of the inclusion and none of the exclusion criteria.
Key inclusion criteria (1 listed)
- All subjects must have been implanted with one of the DVR Plates according to the approved indications.
Key exclusion criteria (8 listed)
- Off-label use.
- Cases where there is an active infection.
- Conditions which tend to retard healing such as, blood supply limitations, previous infections, etc.
- Insufficient quantity or quality of bone to permit stabilization of the fracture.
- Conditions that restrict the patient's ability or willingness to follow postoperative instructions during the healing process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fracture Healing Based on Clinical Measures and X-rays
Time frame: Mean time of 3.8 years after the surgery
Fracture healing will be evaluated by x-rays and clinical measures (no pain at fracture site)
2 secondary outcomes
Product Safety Based on Complications
Time frame: Mean time of 3.8 years after surgery
Patient's Outcomes Were Also Assessed
Time frame: Mean time of 3.8 years after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hassan Achakri study director
Zimmer Biomet
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 Radius Fracture and Distal Ulna Fracture, run by Zimmer Biomet 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 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 20 Nov 2024. 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?
Yes. Results are posted in the registry (first posted 20 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fracture Healing Based on Clinical Measures and X-rays (time frame: Mean time of 3.8 years after the surgery). 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 20 Nov 2024.