Hi-Fatigue G Bone Cement Retrospective Study

NCT06699134 — Recruiting, 90 participants, Zimmer Biomet

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Evaluation of Hi-Fatigue G Bone Cement With Gentamicin A Retrospective Data Collection

Registry	NCT06699134
Status	Recruiting
Study type	Observational
Enrollment	90 (Estimated)
Sponsor	Zimmer Biomet (Industry)
Conditions	Total Hip and Knee Arthroplasties
Interventions	Total knee arthroplasty, Total Hip arthroplasty (Device)
Dates	start 2024-11-19, primary completion 2026-10-01 (estimated), completion 2026-10-01 (estimated), first posted 2024-11-21, last updated 2025-12-02
Locations	1 site in Germany

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Patients with TKA		Device: Total knee arthroplasty	Patients with primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
Patients with THA		Device: Total Hip arthroplasty	Patients with primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant

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

+Outcome measures

Primary outcomes

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).

Secondary outcomes

Survivorship [From enrollment to the 5 year post-op follow up.]: 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.
Patient reported outcome measures (PROM) [From enrollment to the 5 year post-op follow up.]: Evaluation of PROMs, collected in accordance with the hospital standard of care.
Cement Information [From enrollment to the 5 year post-op follow up.]: Obtain information regarding the cementing technique and handling of the cement, if available

+Eligibility

Sex: All, ages: 18 Years to any

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)

+Locations (1)

Facility	City	Country	Status
Klinikum Weiden	Weiden, Bavaria	Germany	Recruiting