Clinical trial NCT06699134: Hi-Fatigue G Bone Cement Retrospective Study
Official title: Evaluation of Hi-Fatigue G Bone Cement With Gentamicin A Retrospective Data Collection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Total Hip and Knee Arthroplasties
Keywords: Bone Cement
Knee Arthroplasty
Hip Arthroplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2024-11-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated with primary total knee or hip replacement using Hi-Fatigue G Bone Cement, a Zimmer Biomet implant, and who meet the inclusion / exclusion criteria for study participation.

Two consecutive groups of patients that underwent cemented TKA or THA according to the instructions for use of both the respective implant and of Hi-Fatigue G Bone Cement.

Brief 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 criteria: 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)

Primary outcomes:
measure: Radiographic evaluation
timeFrame: From enrollment to the 5 year post-op follow up.
Secondary outcomes:
measure: Survivorship
timeFrame: From enrollment to the 5 year post-op follow up.
measure: Patient reported outcome measures (PROM)
timeFrame: From enrollment to the 5 year post-op follow up.
measure: Cement Information
timeFrame: From enrollment to the 5 year post-op follow up.
Other outcomes:
Locations:
city: Weiden
country: Germany
facility: Klinikum Weiden
state: Bavaria
Study officials:
References: