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

Peter Brehm GmbH28 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Patient relevant benefit after 5 years

improvement of KSS-Score by at least one category as compared to preoperative basic assessment

Time frame: 5 years