Hi-Fatigue G Bone Cement Retrospective Study

Zimmer Biomet90 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Total Hip and Knee Arthroplasties

Interventions

Total knee arthroplastyDEVICE

Primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Radiographic evaluation

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

Time frame: From enrollment to the 5 year post-op follow up.

Secondary Outcomes

Survivorship

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.

Time frame: From enrollment to the 5 year post-op follow up.

Patient reported outcome measures (PROM)

Evaluation of PROMs, collected in accordance with the hospital standard of care.

Time frame: From enrollment to the 5 year post-op follow up.

Cement Information

Obtain information regarding the cementing technique and handling of the cement, if available

Time frame: From enrollment to the 5 year post-op follow up.

Hi-Fatigue G Bone Cement Retrospective Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts