Clinical trial NCT05215626: PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Reconstruction System
Official title: Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Zimmer® Reconstruction System (Implant and Instrumentation) - A Retrospective Consecutive Series Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acetabulum Fracture
Pelvic Ring Fracture
Keywords: Acetabulum Fracture
Pelvic Ring Fracture
Medical Device
Clinical Benefits
Safety
Performance
Post Market Clinical Follow Up Study
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2022-01-31
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive series of cases implanted with the Zimmer Reconstruction System according to Zimmer Biomet's Instruction for USE (IFU) and who meet the inclusion criteria and none of the exclusion criteria.

Brief summary: The study is a monocentric, 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 Reconstruction System (implants and instrumentation) when used for temporary internal fixation and stabilization of fractures during the normal healing process.

The primary objective is the assessment of performance by analyzing fracture healing.

The secondary objectives are the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Subjects' outcomes will also be assessed.

Detailed description: The Reconstruction System is especially used to stabilize pelvic ring and acetabulum fractures. One site will be involved in this study. The aim is to include a maximum of 83 consecutive series cases who received the Zimmer Reconstruction System at the Azienda Ospedaliero Universitaria Senese (Siena, Italy) between 2010 and 2018. All potential study subjects will be required to participate to 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. In addition, any complications since the last consultation visit at the clinic and information about the treatment of the complications will also be collected retrospectively.

Eligibility criteria: Inclusion Criteria:

Patients having received the Zimmer Reconstruction System for temporary internal fixation and stabilization of fractures during the normal healing process

Exclusion Criteria:

* Off-label use
* Patients under the age of 18
* Severely comminuted fractures in which bone fragments are too small or numerous to adequately fix or maintain a reduced position
* Infection
* Metal sensitivity or intolerance
* Severe osteopenia and/or osteoporosis, or in the presence of marked or rapid bone absorption, metabolic bone disease, cancer, or any other tumor-like condition of the bone which may compromise fixation
* Sternal or spinal fractures
* Anatomical location in which the device would interfere with nerves, blood vessels, or other vital structures
* Patients with inadequate soft tissue coverage at the implant site

Primary outcomes:
measure: Performance: Fracture healing
timeFrame: At last consultation visit at minimum 1 year postoperative.
Secondary outcomes:
measure: Product safety
timeFrame: At operative evaluation, immediate post-operative evaluation and at last consultation visit at minimum 1 year postoperative.
measure: Harris Hip Score
timeFrame: At last consultation visit at minimum 1 year postoperative.
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Azienda Ospedaliero Universitaria Senese
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: