Hi-Fatigue G Bone Cement Retrospective Study

NCT06699134 | Recruiting

• 1 other identifier: CME2020-38C
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Total Hip and Knee Arthroplasties

Keywords

Bone Cement; Knee Arthroplasty; Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Radiographic evaluation

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

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

Secondary Outcomes (3)

• Survivorship

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

• Patient reported outcome measures (PROM)

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

• Cement Information

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

Study Arms (2)

Patients with TKA

Patients with primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant

Device: Total knee arthroplasty

Patients with THA

Patients with primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant

Device: Total Hip arthroplasty

Interventions

Total knee arthroplasty DEVICE

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

Patients with TKA

Total Hip arthroplasty DEVICE

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

Patients with THA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Klinikum Weiden

Weiden, Bavaria, 92637, Germany

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

Miguel Correa-Tapia

CONTACT

+41791522905; Miguel.CorreaTapia@zimmerbiomet.com

Linda Meijer

CONTACT

+31657933741; linda.meijer@zimmer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: November 19, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12

Locations

DE (1)