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

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 Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee; Joint Instability
• Intervention / Treatment: Device: BPK-S Integration

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Belgium
  • Tournai, Belgium, 7500
    • Centre Hospitalier de Wallonie picarde - CHwapi A.S.B.L
  • Tournai, Belgium, 7500
    • Medical Center Tournai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that received a BPK-S Integration in the variant CoCr as primary total knee endoprosthesis between 2011 and 2013 implanted by the investigator

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peter Brehm GmbH
• Collaborators: P.R.I.S.M.A.-CRO

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2018
• Primary Completion (ACTUAL): March 2, 2020
• Study Completion (ACTUAL): March 2, 2020

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 15, 2018
• First Posted (ACTUAL): January 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Joint Instability
• Other Study ID Numbers: 2016-01-BPK-S

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No