Hi-Fatigue G Bone Cement Retrospective Study

Zimmer Biomet

Status

Enrolling

Conditions

Total Hip and Knee Arthroplasties

Treatments

Device: Total knee arthroplasty

Device: Total Hip arthroplasty

Study type

Observational

Funder types

Industry

Identifiers

NCT06699134

CME2020-38C

Details and patient eligibility

About

The objective of this retrospective monocentric study is to collect survivorship and clinical data confirming safety, performance and clinical benefits for the Hi-Fatigue G Bone Cement.

The assessments will include:

Radiological analysis performed at different time points according to the standard of care of the hospital
Implant survivorship and safety based on removal of a study device
Patient reported outcome measures (PROMs)

Primary endpoint:

Assessment of radiolucent lines around the components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care).

Secondary endpoints:

Evaluation of implant survivorship and safety by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
Evaluation of PROMs
Obtain information regarding the cementing technique and handling of the cement, if available

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject qualified for cemented TKA or THA with a Zimmer Biomet implant
Subject is willing and able to give written informed consent for retrospective data collection and undergo interim and final evaluation (X-Ray & Scores completion)
Subject > 18 years old

Exclusion criteria

Muscle wasting
Neuromuscular compromise in the affected limb
Known hypersensitivity to any of the cement constituents
Subjects with severe renal failure
Bilateral interventions
Subject is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, known alcohol or drug abuser, anticipated to be non-compliant)