Trials Sponsors Conditions Drugs Pricing

Conditions

Acetabulum Fracture Pelvic Ring Fracture

Keywords

Acetabulum FracturePelvic Ring FractureMedical DeviceClinical BenefitsSafetyPerformancePost Market Clinical Follow Up Study

Outcome Measures

Primary Outcomes (1)

Performance: Fracture Healing
Performance will be assessed by analyzing fracture healing radiographically by X-rays.
Mean time of 1.99 years after the surgery

Secondary Outcomes (2)

Product Safety
Mean time of 1.99 years after the surgery
Harris Hip Score
Mean time of 1.99 years after the surgery

Study Arms (1)

Patients implanted with the Zimmer Reconstruction System

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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.

You may qualify if:

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

Sponsors & Collaborators

Zimmer Biomet
Industrylead

Study Sites (1)

Azienda Ospedaliero Universitaria Senese

Siena, 53100, Italy

Limitations and Caveats

A limitation to this study is its retrospective and fully anonymized design. Due to the fully anonymized design, no further information on complications and adverse events can be collected for this study.

Results Point of Contact

Title: Georgia Tsapara
Organization: Zimmer Biomet

Study Officials

Emilie Rohmer
Zimmer Biomet
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: LTE60
Restrictive Agreement: Yes

Enrollment

78 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 28, 2022

First Posted

January 31, 2022

Study Start

August 1, 2022

Actual (reported)

PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Reconstruction System

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Patients implanted with the Zimmer Reconstruction System

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Patients implanted with the Zimmer Reconstruction System

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations