Total Hip and Knee Arthroplasties
Conditions
Keywords
Bone Cement, Knee Arthroplasty, Hip Arthroplasty
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
Interventions
DEVICETotal knee arthroplasty
Primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
DEVICETotal Hip arthroplasty
Primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Contacts
Primary ContactMiguel Correa-Tapia
Backup ContactLinda Meijer
Outcome results
None listed