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Distal Radius Fracture
+2

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

Sponsored by Zimmer Biomet

About this trial

Last updated 3 years ago

Study ID

MDRG2017-89MS-14T

Status

Active, not recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
All
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

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

No

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.

Locations

Location

Status