Combined Prospective and Retrospective Post-Market Follow Up of the 'BPK-S Integration' UC as Primary Implant in the Variant CoCr

Completed

• Conditions: Osteoarthritis, Knee; Joint Instability

• Registration Number: NCT03406637
• Lead Sponsor: Peter Brehm GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-15
• Study First Posted: 2018-01-23
• Study Start: 2018-10-17
• Status Verified: 2020-03
• Primary Completion: 2020-03-02
• Study Completion: 2020-03-02
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient relevant benefit after 5 years	7 years	improvement of KSS-Score by at least one category as compared to preoperative basic assessment

Secondary Outcome Measures

Name	Time	Method
Revision Number	7 years	Number of revisions, if required
Revision Reason	7 years	Reason for revision, if required
Patient relevant benefit as measured by American Knee Society Score	1 year	improvement of KSS-Score as compared to preoperative basic assessment
Safety parameters	7 years	Incidents that require reporting to the competent authority and complications during and after surgery as documented in source documentation
Implant Loosening Number	7 years	Number of implant loosening due to quality issues with the implant
Implant Loosening Reason	7 years	Reason for implant loosening due to quality issues with the implant
Surgery Parameters	Day 0 = day of surgery	Evaluation of tourniquet time as documented in the surgical report

Trial Locations

Locations (2)

Centre Hospitalier de Wallonie picarde - CHwapi A.S.B.L; 🇧🇪 Tournai, Belgium

Medical Center Tournai; 🇧🇪 Tournai, Belgium