Hi-Fatigue G Bone Cement Retrospective Study

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Total Hip arthroplasty: Primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant

Study summary

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

Eligibility

Primary outcome measure(s)

• Radiographic evaluation — From enrollment to the 5 year post-op follow up.
  Detection of radiolucent lines around the implant components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care).

Trial sites (1)

More Zimmer Biomet trials in Germany