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

Distal Radius Fracture Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04653051
• Other study ID #: MDRG2017-89MS-14T
• Status: Active, not recruiting
• Start date: March 12, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: September 2022
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The secondary objective is the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: October 30, 2022
• Est. primary completion date: October 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Distal Radius Fracture
• Distal Ulna Fracture
• Fractures, Bone
• Osteotomy
• Radius Fractures
• Ulna Fractures

Locations

Country	Name	City	State
United Kingdom	Southampton General Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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