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

PETER BREHM

Status: Terminated

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

Treatments: Device: BPK-S Integration UC

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03293719

2017-02-BPK-S Comparison

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

28 participants in 2 patient groups

Ceramic

Description:

Patients receiving BPK-S Integration UC implant made from BIOLOX delta ceramic

Treatment:

Device: BPK-S Integration UC

CoCr

Description:

Patients receiving BPK-S Integration UC implant made from CoCr (metal)

Treatment:

Device: BPK-S Integration UC