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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03406637
• Other study ID #: 2016-01-BPK-S
• Status: Completed
• Start date: October 17, 2018
• Est. completion date: March 2, 2020

Study information

• Verified date: March 2020
• Source: Peter Brehm GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 2, 2020
• Est. primary completion date: March 2, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Joint Instability
• Osteoarthritis, Knee

Intervention

Device:
• BPK-S Integration
primary total knee endoprosthesis

Locations

Country	Name	City	State
Belgium	Centre Hospitalier de Wallonie picarde - CHwapi A.S.B.L	Tournai
Belgium	Medical Center Tournai	Tournai

Sponsors (2)

Lead Sponsor	Collaborator
Peter Brehm GmbH	P.R.I.S.M.A.-CRO

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient relevant benefit after 5 years	improvement of KSS-Score by at least one category as compared to preoperative basic assessment	7 years
Secondary	Safety parameters	Incidents that require reporting to the competent authority and complications during and after surgery as documented in source documentation	7 years
Secondary	Patient relevant benefit as measured by American Knee Society Score	improvement of KSS-Score as compared to preoperative basic assessment	1 year
Secondary	Implant Loosening Number	Number of implant loosening due to quality issues with the implant	7 years
Secondary	Implant Loosening Reason	Reason for implant loosening due to quality issues with the implant	7 years
Secondary	Revision Number	Number of revisions, if required	7 years
Secondary	Revision Reason	Reason for revision, if required	7 years
Secondary	Surgery Parameters	Evaluation of surgery time as documented in the surgical report	Day 0 = day of surgery
Secondary	Surgery Parameters	Evaluation of tourniquet time as documented in the surgical report	Day 0 = day of surgery