N/A
Completed N=111
PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System
Distal Radius Fracture · Distal Ulna Fracture · Osteotomy
Source: ClinicalTrials.gov NCT04653051 ↗
Enrolled (actual)
111
Serious AEs
3.6%
Results posted
Nov 2024
Primary outcomePrimary: Fracture Healing Based on Clinical Measures and X-rays — 103; 2; 10; 114 cases
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fracture Healing Based on Clinical Measures and X-rays |
103; 2; 10; 114; 0; 1 | — |
| SECONDARY Product Safety Based on Complications |
77; 4; 11; 0 | — |
| SECONDARY Patient's Outcomes Were Also Assessed |
12.8; 8.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04653051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.