Osteoarthritis, Knee Clinical Trial
Official title:
Combined Prospective / Retrospective, Open, Non-randomized, Non-interventional Post Market Clinical Follow-Up of the BPK-S Integration System (Co28Cr6Mo) Used for Primary Total Knee Replacement
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.
n/a
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