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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with TKA | Patients with primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant |
| |
| Patients with THA | Patients with primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee arthroplasty | Device | Primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship | 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. | From enrollment to the 5 year post-op follow up. |
| Patient reported outcome measures (PROM) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miguel Correa-Tapia | Contact | +41791522905 | Miguel.CorreaTapia@zimmerbiomet.com | |
| Linda Meijer | Contact | +31657933741 | linda.meijer@zimmer.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Weiden | Recruiting | Weiden | Bavaria | 92637 | Germany |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Total Hip arthroplasty | Device | Primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant |
|
Evaluation of PROMs, collected in accordance with the hospital standard of care. |
| From enrollment to the 5 year post-op follow up. |
| Cement Information | Obtain information regarding the cementing technique and handling of the cement, if available | From enrollment to the 5 year post-op follow up. |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |