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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03406637
Other study ID # 2016-01-BPK-S
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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