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PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System
trial in Distal Radius Fracture in 111 participants. Completed in 15 November 2022.
| Lead sponsor | Zimmer Biomet |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 111 |
| Start date | 12 March 2021 |
| Primary completion | 3 October 2021 |
| Estimated completion | 15 November 2022 |
| Sites | 1 location across United Kingdom |
Zimmer Biomet — full company profile →
Eligibility, any sex, with Distal Radius Fracture or Distal Ulna Fracture. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Fracture healing will be evaluated by x-rays and clinical measures (no pain at fracture site)
| Group | Value | 95% CI |
|---|---|---|
| DVR Plating System | 103 | |
| DVR Plating System | 2 | |
| DVR Plating System | 10 |
| Group | Value | 95% CI |
|---|---|---|
| DVR Plating System | 114 | |
| DVR Plating System | 0 | |
| DVR Plating System | 1 |
Safety will be assessed by recording and analyzing the incidence and frequency of complications. The complications are classified per ISO 14155 Definitions: Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs). .
| Group | Value | 95% CI |
|---|---|---|
| DVR Plating System | 77 |
| Group | Value | 95% CI |
|---|---|---|
| DVR Plating System | 4 |
| Group | Value | 95% CI |
|---|---|---|
| DVR Plating System | 11 |
| Group | Value | 95% CI |
|---|---|---|
| DVR Plating System | 0 |
Patients were asked to complete a patient questionnaire (Patient-Rated Wrist Evaluation Score- PRWE)\* and a question on their wrist function\*\* \* the PRWE is a self-administered, patient-specific questionnaire that consists of 15 items. It was designed to measure wrist pain and disability in activities of daily living, and consists of two subscales: pain and function. A score of 100 represents the worst functional score, whereas 0 represents no disability \*\* Patient reported outcome: assessment of fractured wrist comparing to before injury on a scale from 0 to 10, 0 being worst imaginab
| Group | Value | 95% CI |
|---|---|---|
| DVR Plating System | 12.8 | ± 17.9 |
| Group | Value | 95% CI |
|---|---|---|
| DVR Plating System | 8.0 | ± 2.1 |
Time frame: Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 111 Subjects Received DVR … |
|---|---|---|
| Altered sensation of the median nerve | Nervous system disorders | — |
| Car accident | Injury, poisoning and procedural complications | — |
| Reduced mobility | Musculoskeletal and connective tissue disorders | — |
| Kienbock's disease | Vascular disorders | — |
| Reaction | System | 111 Subjects Received DVR … |
|---|---|---|
| Polytrauma | Injury, poisoning and procedural complications | — |
| Reduced ROM | Musculoskeletal and connective tissue disorders | — |
| Arthritis | Immune system disorders | — |
| Loss of power and grip strenght | Musculoskeletal and connective tissue disorders | — |
| Pain in wrist | Musculoskeletal and connective tissue disorders | — |
| Stiffness and pain | Musculoskeletal and connective tissue disorders | — |
| Additional fall | Injury, poisoning and procedural complications | — |
| Plate removal | Product Issues | — |
| Shooting spasm pains | Musculoskeletal and connective tissue disorders | — |
| Pain | Musculoskeletal and connective tissue disorders | — |
| Mild ache | Musculoskeletal and connective tissue disorders | — |
| Pain in wrist | Musculoskeletal and connective tissue disorders | — |
| Tingling sensation | Skin and subcutaneous tissue disorders | — |
| Stiffness and irritation caused by the plate | Product Issues | — |
| Pins and needles feeling | Nervous system disorders | — |
| Pain combined with stiffness | Musculoskeletal and connective tissue disorders | — |
| Reduced strength | Musculoskeletal and connective tissue disorders | — |
| Pain due to altered sensation | Nervous system disorders | — |
| Plate removal | Nervous system disorders | — |
| Shoulder/ arm pain | Musculoskeletal and connective tissue disorders | — |
| Loose screw | Product Issues | — |
| Rotator cuff impingement | Nervous system disorders | — |
| Collapsed joint line | Musculoskeletal and connective tissue disorders | — |
| Intermittent pain and instability | Musculoskeletal and connective tissue disorders | — |
| Lower Respiratory Tract Infection (LRTI) | Infections and infestations | — |
| Low wrist function | Musculoskeletal and connective tissue disorders | — |
| Discomfort and pain | Product Issues | — |
| Aching and pain | Musculoskeletal and connective tissue disorders | — |
| Long recovery | Musculoskeletal and connective tissue disorders | — |
| Complex Regional Pain Syndrome | Musculoskeletal and connective tissue disorders | — |
| Pain when lifting heavy objects | Musculoskeletal and connective tissue disorders | — |
| Occasional pain and slightly reduced ROM | Musculoskeletal and connective tissue disorders | — |
| Numbness | Nervous system disorders | — |
| Swollen wrist | Musculoskeletal and connective tissue disorders | — |
| Polymyalgia | Musculoskeletal and connective tissue disorders | — |
| Shooting nerve pain in wrist | Nervous system disorders | — |
| Stitches opened | Skin and subcutaneous tissue disorders | — |
| Bones moving forward | Injury, poisoning and procedural complications | — |
| Clicking and minor weakness | Musculoskeletal and connective tissue disorders | — |
| Thicker wrist | Product Issues | — |
Most-reported serious reactions: Altered sensation of the median nerve, Car accident, Reduced mobility, Kienbock's disease.
Data from ClinicalTrials.gov NCT04653051 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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