Combined Prospective and Retrospective Post-Market Follow Up of the 'BPK-S Integration' UC as Primary Implant in the Variant CoCr
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
1 other identifier
observational
62
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2018
CompletedFirst Posted
Study publicly available on registry
January 23, 2018
CompletedStudy Start
First participant enrolled
October 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2020
CompletedMarch 6, 2020
March 1, 2020
1.4 years
January 8, 2018
March 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Patient relevant benefit after 5 years
improvement of KSS-Score by at least one category as compared to preoperative basic assessment
7 years
Secondary Outcomes (8)
Safety parameters
7 years
Patient relevant benefit as measured by American Knee Society Score
1 year
Implant Loosening Number
7 years
Implant Loosening Reason
7 years
Revision Number
7 years
- +3 more secondary outcomes
Interventions
primary total knee endoprosthesis
Eligibility Criteria
Patients that received a BPK-S Integration in the variant CoCr as primary total knee endoprosthesis between 2011 and 2013 implanted by the investigator
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peter Brehm GmbHlead
- P.R.I.S.M.A.-CROcollaborator
Study Sites (2)
Centre Hospitalier de Wallonie picarde - CHwapi A.S.B.L
Tournai, 7500, Belgium
Medical Center Tournai
Tournai, 7500, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2018
First Posted
January 23, 2018
Study Start
October 17, 2018
Primary Completion
March 2, 2020
Study Completion
March 2, 2020
Last Updated
March 6, 2020
Record last verified: 2020-03