Hi-Fatigue G Bone Cement Retrospective Study
ConditionTotal Hip and Knee Arthroplasties
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZimmer Biomet
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Muscle wasting
Neuromuscular compromise in the affected limb
Known hypersensitivity to any of the cement constituents
Subjects with severe renal failure
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Total knee arthroplasty
DevicePrimary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
Total Hip arthroplasty
DevicePrimary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Patients with TKA1 intervention
Group B: Patients with THA1 intervention
Trial outcomes
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).
Time frame
From enrollment to the 5 year post-op follow up.Secondary outcomes
1
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.
Time frame
From enrollment to the 5 year post-op follow up.2
Patient reported outcome measures (PROM)
Evaluation of PROMs, collected in accordance with the hospital standard of care.
Time frame
From enrollment to the 5 year post-op follow up.3
Cement Information
Obtain information regarding the cementing technique and handling of the cement, if available
Time frame
From enrollment to the 5 year post-op follow up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov