Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr or Ceramic

Study Overview
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Brief Summary
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Prospective Post-Market Clinical Follow up study according to MEDDEV 2.12/2 rev2 of the European Union. Patients receiving the primary knee implant BPK-S UC as primary implant in either variant ceramic or CoCr (metal) are eligible for the study and will be followed up for 5 years after implantation or until revision of the prosthesis, whichever occurs first. Demographic data will be collected together with data regarding safety and benefit at defined timepoints (preoperative, intraoperative and at 3 months, 1 year, 2 years and 5 years after implantation). Patients will be divided in 2 cohorts (ceramic and metal) and stratified by age.

Official Title
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Prospective, Open, Non-randomized, Non-interventional Explorative, Comparative, Uncontrolled Cohort Study for Post Market Clinical Follow-Up of the BPK-S Integration UC in the Variants CoCr or Ceramic as Primary Implant

Conditions
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Osteoarthritis, Osteoarthritis, Knee, Joint Instability, Arthritis, Joint Disease, Musculoskeletal Disease, Rheumatic Diseases

Intervention / Treatment
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* Device: BPK-S Integration UC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Congenital or acquired knee joint defects/deformation Defects or malfunction of the knee joint Arthrosis (degenerative, rheumatic) Post-traumatic arthritis Symptomatic knee instability Reconstruction of flexibility Patients with metal hypersensitivity (ceramic tibia/femur) Exclusion Criteria: Illnesses which can be treated without using a knee joint implant. Acute or chronic infections near the implantation Systemic diseases and metabolic disorders Serious osteoporosis Serious damage to the bone structures that impedes stable implantation of the implant components Diseases that impair bone growth, e.g. cancer, renal dialysis, osteopenia, etc. Bone tumors in the area of the implant anchoring Obesity or overweight of the patient Overload of the knee implant to be expected Abuse of medication, drug abuse, alcoholism or mental disease Pregnancy Lack of patient cooperation Sensitivity to foreign matter in the implant materials Patients under the age of 18 Patients participating in another trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ceramic<br>Patients receiving BPK-S Integration UC implant made from BIOLOX delta ceramic | Device: BPK-S Integration UC<br>* Primary Knee Endoprosthesis<br>|
| CoCr<br>Patients receiving BPK-S Integration UC implant made from CoCr (metal) | Device: BPK-S Integration UC<br>* Primary Knee Endoprosthesis<br>|

What is the study measuring?
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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 | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient relevant benefit as measured by American Knee Society Score | improvement of KSS-Score as compared to preoperative basic assessment | 3 months, 1, 2 and 5 years | 
| Patient relevant benefit as measured by Knee Osteoarthritis Outcome Score | Improvement of KOOS as compared to preoperative basic assessment | 3 months, 1, 2 and 5 years | 
| Patient Quality of Life | Improvement of EQ-5D as compared to preoperative basic assessment | 3 months, 1, 2 and 5 years | 
| Implant Loosening Number | Number of implant loosening due to quality issues with the implant | 3 months, 1, 2 and 5 years | 
| Implant Loosening Reason | Reason for implant loosening due to quality issues with the implant | 3 months, 1, 2 and 5 years | 
| Revision Number | Number of revisions, if required | 3 months, 1, 2 and 5 years | 
| Revision Reason | Reason for revision, if required | 3 months, 1, 2 and 5 years |