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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Peter Brehm GmbH
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Patient relevant benefit after 5 years
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients that received a total primary knee endoprosthesis BPK-S Integration (Co28Cr6Mo) between 2011 and 2013
- •Patients that agree to participate and give written informed consent to the anonymized retrospective and prospective data collection within the study
Exclusion Criteria
- •No study specific exclusion criteria are defined for this PMCF study.
Outcomes
Primary Outcomes
Patient relevant benefit after 5 years
Time Frame: 7 years
improvement of KSS-Score by at least one category as compared to preoperative basic assessment
Secondary Outcomes
- Revision Number(7 years)
- Revision Reason(7 years)
- Patient relevant benefit as measured by American Knee Society Score(1 year)
- Safety parameters(7 years)
- Implant Loosening Number(7 years)
- Implant Loosening Reason(7 years)
- Surgery Parameters(Day 0 = day of surgery)