PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Distal Radius Fracture; Osteotomy; Distal Ulna Fracture

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 Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• United Kingdom
  • Southampton, United Kingdom
    • Southampton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients must have received one of the DVR Plates and who meet all of the inclusion and none of the exclusion criteria.

Description

Inclusion Criteria:

• All subjects must have been implanted with one of the DVR Plates according to the approved indications.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients who received DVR Plating System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fracture healing based on clinical measures and/or x-rays	Fracture healing will be evaluated by x-rays and/or clinical measures (no pain at fracture site)	From last consultation visit to follow-up phone call, 2-6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Product safety based on complication and adverse events	Safety will be assessed by recording and analyzing the incidence and frequency of complications and adverse events	From operation to study completion, 2-6 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Actual): October 3, 2021
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Performance; Medical Device; Clinical Benefits; Post-Market Clinical Follow-Up Study
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures; Ulna Fractures
• Other Study ID Numbers: MDRG2017-89MS-14T

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No