Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr or Ceramic
- Conditions
- ArthritisJoint DiseaseMusculoskeletal DiseaseJoint InstabilityRheumatic DiseasesOsteoarthritisOsteoarthritis, Knee
- Interventions
- Device: BPK-S Integration UC
- Registration Number
- NCT03293719
- Lead Sponsor
- Peter Brehm GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ceramic BPK-S Integration UC Patients receiving BPK-S Integration UC implant made from BIOLOX delta ceramic CoCr BPK-S Integration UC Patients receiving BPK-S Integration UC implant made from CoCr (metal)
- Primary Outcome Measures
Name Time Method Patient relevant benefit after 5 years 5 years improvement of KSS-Score by at least one category as compared to preoperative basic assessment
- Secondary Outcome Measures
Name Time Method Implant Loosening Number 3 months, 1, 2 and 5 years Number of implant loosening due to quality issues with the implant
Implant Loosening Reason 3 months, 1, 2 and 5 years Reason for implant loosening due to quality issues with the implant
Patient relevant benefit as measured by American Knee Society Score 3 months, 1, 2 and 5 years improvement of KSS-Score as compared to preoperative basic assessment
Patient Quality of Life 3 months, 1, 2 and 5 years Improvement of EQ-5D as compared to preoperative basic assessment
Patient relevant benefit as measured by Knee Osteoarthritis Outcome Score 3 months, 1, 2 and 5 years Improvement of KOOS as compared to preoperative basic assessment
Revision Number 3 months, 1, 2 and 5 years Number of revisions, if required
Revision Reason 3 months, 1, 2 and 5 years Reason for revision, if required
Trial Locations
- Locations (1)
SMZ Ost, Donauspital
🇦🇹Vienna, Oberösterreich, Austria