An observational study in Osteoarthritis, Osteoarthritis, Knee and Joint Instability, sponsored by Peter Brehm GmbH. Terminated at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-19.
Sponsored by Peter Brehm GmbH · Observational
Prospective Post-Market Clinical Follow up study according to MEDDEV 2.12/2 rev2 of the European Union. Patients receiving the primary knee implant BPK-S UC as primary implant in either variant ceramic or CoCr (metal) are eligible for the study and will be followed up for 5 years after implantation or until revision of the prosthesis, whichever occurs first. Demographic data will be collected together with data regarding safety and benefit at defined timepoints (preoperative, intraoperative and at 3 months, 1 year, 2 years and 5 years after implantation).
Patients will be divided in 2 cohorts (ceramic and metal) and stratified by age.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 28 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.
Compared within Osteoarthritis, Knee, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Osteoarthritis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients undergoing primary total knee endoprosthesis with BPK-S Integration of age 18 and older
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:
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving BPK-S Integration UC implant made from BIOLOX delta ceramic
Device: BPK-S Integration UC
Patients receiving BPK-S Integration UC implant made from CoCr (metal)
Device: BPK-S Integration UC
Primary 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: 5 years
Patient relevant benefit as measured by American Knee Society Score
improvement of KSS-Score as compared to preoperative basic assessment
Time frame: 3 months, 1, 2 and 5 years
Patient relevant benefit as measured by Knee Osteoarthritis Outcome Score
Improvement of KOOS as compared to preoperative basic assessment
Time frame: 3 months, 1, 2 and 5 years
Patient Quality of Life
Improvement of EQ-5D as compared to preoperative basic assessment
Time frame: 3 months, 1, 2 and 5 years
Implant Loosening Number
Number of implant loosening due to quality issues with the implant
Time frame: 3 months, 1, 2 and 5 years
Implant Loosening Reason
Reason for implant loosening due to quality issues with the implant
Time frame: 3 months, 1, 2 and 5 years
Revision Number
Number of revisions, if required
Time frame: 3 months, 1, 2 and 5 years
Revision Reason
Reason for revision, if required
Time frame: 3 months, 1, 2 and 5 years
Ran from Mar 2018 to primary completion in Oct 2019, 18 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Peter Brehm GmbH