Clinical trial NCT04653051: PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Radius Fracture
Distal Ulna Fracture
Osteotomy
Keywords: Medical Device
Performance
Safety
Clinical Benefits
Post-Market Clinical Follow-Up Study
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2020-12-04
Enrollment: 111
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed 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.

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.

Primary outcomes:
measure: Fracture Healing Based on Clinical Measures and X-rays
timeFrame: Mean time of 3.8 years after the surgery
Secondary outcomes:
measure: Product Safety Based on Complications
timeFrame: Mean time of 3.8 years after surgery
measure: Patient's Outcomes Were Also Assessed
timeFrame: Mean time of 3.8 years after surgery
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: