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

NCT04653051 | Completed Results

• 1 other identifier: MDRG2017-89MS-14T
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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. Patients' outcomes will also be assessed.

Conditions

Distal Radius Fracture; Distal Ulna Fracture; Osteotomy

Keywords

Medical Device; Performance; Safety; Clinical Benefits; Post-Market Clinical Follow-Up Study

Outcome Measures

Primary Outcomes (1)

• 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)

  Mean time of 3.8 years after the surgery

Secondary Outcomes (2)

• Product Safety Based on Complications

  Mean time of 3.8 years after surgery

• Patient's Outcomes Were Also Assessed

  Mean time of 3.8 years after surgery

Study Arms (1)

Patients who received DVR Plating System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Southampton General Hospital

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Limitations and Caveats

The limitations of this study are that it was retrospective, over the pandemic and required extensive hours of discussion and contacting of patients which took extended time.

Results Point of Contact

• Title: Georgia Tsapara
• Organization: Zimmer Biomet

georgia.tsapara@zimmerbiomet.com

+41 79 94 54936

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 4, 2020
• Study Start: March 12, 2021
• Primary Completion: October 3, 2021
• Study Completion: November 15, 2022
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-09

Locations

GB (1)