Hi-Fatigue G Bone Cement Retrospective Study

Recruiting

• Conditions: Total Hip and Knee Arthroplasties

• Registration Number: NCT06699134
• Lead Sponsor: Zimmer Biomet

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-11-19
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Study First Posted: 2024-11-21
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Klinikum Weiden; 🇩🇪 Weiden, Bavaria, Germany