Clinical trial NCT03406637: Combined Prospective and Retrospective Post-Market Follow Up of the 'BPK-S Integration' UC as Primary Implant in the Variant CoCr
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Joint Instability
Lead sponsor: Peter Brehm GmbH
Sponsor class: INDUSTRY
Collaborators: name: P.R.I.S.M.A.-CRO
First posted: 2018-01-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient relevant benefit after 5 years
timeFrame: 7 years
Secondary outcomes:
measure: Safety parameters
timeFrame: 7 years
measure: Patient relevant benefit as measured by American Knee Society Score
timeFrame: 1 year
measure: Implant Loosening Number
timeFrame: 7 years
measure: Implant Loosening Reason
timeFrame: 7 years
measure: Revision Number
timeFrame: 7 years
measure: Revision Reason
timeFrame: 7 years
measure: Surgery Parameters
timeFrame: Day 0 = day of surgery
measure: Surgery Parameters
timeFrame: Day 0 = day of surgery
Other outcomes:
Locations:
city: Tournai
country: Belgium
facility: Centre Hospitalier de Wallonie picarde - CHwapi A.S.B.L
city: Tournai
country: Belgium
facility: Medical Center Tournai
Study officials:
References: