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

Study Overview
=================
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.

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

Conditions
-----------------
Osteoarthritis, Knee, Joint Instability

Intervention / Treatment
-----------------
* Device: BPK-S Integration


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: BPK-S Integration|primary total knee endoprosthesis|

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 |