An observational study in Osteoarthritis, Knee and Joint Instability, sponsored by Peter Brehm GmbH. Completed at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-06.
Sponsored by Peter Brehm GmbH · Observational
Patients who received a total knee endoprosthesis BPK-S Integration between 2011 and 2013 will be invited to participate in this PMCF study provided sufficient source data documentation is available regarding preoperative, intraoperative and early postoperative follow-up assessments.
Only patients providing written informed consent prior to any study data collection can take part in the study.
Preoperative, intraoperative and early postoperative data (3 months, 1 year and 2 years after implantation) will be collected retrospectively. Additional long-term follow-up of one visit (year 7 after implantation) will be documented prospectively.
Only parameters assessed in clinical standard care for follow-up (implant control) visits will be collected for this PMCF study.
Radiological assessment of the implanted prosthesis will only be conducted if medically indicated according to the investigator. No additional study related assessment will be performed.
Only anonymized data will be used in this observational study to protect patient privacy. No personally identifiable information will be collected.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 62 is below the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Peter Brehm GmbH is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients that received a BPK-S Integration in the variant CoCr as primary total knee endoprosthesis between 2011 and 2013 implanted by the investigator
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No study specific exclusion criteria are defined for this PMCF study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
primary total knee endoprosthesis
Patient relevant benefit after 5 years
improvement of KSS-Score by at least one category as compared to preoperative basic assessment
Time frame: 7 years
Safety parameters
Incidents that require reporting to the competent authority and complications during and after surgery as documented in source documentation
Time frame: 7 years
Patient relevant benefit as measured by American Knee Society Score
improvement of KSS-Score as compared to preoperative basic assessment
Time frame: 1 year
Implant Loosening Number
Number of implant loosening due to quality issues with the implant
Time frame: 7 years
Implant Loosening Reason
Reason for implant loosening due to quality issues with the implant
Time frame: 7 years
Revision Number
Number of revisions, if required
Time frame: 7 years
Revision Reason
Reason for revision, if required
Time frame: 7 years
Surgery Parameters
Evaluation of surgery time as documented in the surgical report
Time frame: Day 0 = day of surgery
Surgery Parameters
Evaluation of tourniquet time as documented in the surgical report
Time frame: Day 0 = day of surgery
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.