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
- OPS 5-822 coding: Implantation of an endoprosthesis at the knee joint
- Registration Number
- DRKS00013063
- Lead Sponsor
- PETER BREHM GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- 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
- Primary Outcome Measures
Name Time Method Patient relevant benefit after 5 years [ Time Frame: 5 years ]: <br>Improvement of KSS-Score by at least one category as compared to preoperative basic assessment
- Secondary Outcome Measures
Name Time Method