BPK-S Integration (Ceramic) Post Market Clinical Follow-Up

Klemens Trieb

Status: Unknown

Conditions: Restoration if Knee Joint Function

Treatments: Device: BPK-S Integration (Ceramic)

Study type: Observational

Funder types: Other

Identifiers

NCT03097471

BPK-S-(pKK)-01-2011

Details and patient eligibility

About

Post-market prospective clinical study with a medical device. Data from patients that routinely receive a primary BPK-S-integration knee implant made of ceramic will be documented with a follow-up time of 2 years.

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Congenital or acquired knee joint defects/deformation which necessitate the implantation of a knee joint replacement
• Defects or malfunctions of the knee joint
• Degenerative, rheumatic, post-traumatic arthritis/arthrosis
• Symptomatic knee instability
• Reconstruction of flexibility
• Patients with material hypersensitivity

Exclusion criteria

• Obesity or overweight of the patient
• Acute or chronic infections near the implantation
• Diseases that impair bone growth such as cancer, renal dialysis, osteopenia, etc.
• Sensitivity to foreign matter in the implant materials
• Bone tumors in the area of the implant anchoring
• Illnesses which can be treated without using a knee implant
• Lack of patient cooperation
• Abuse of medication, drug abuse, alcoholism or mental disease
• Pregnancy
• Serious osteoporosis
• Serious damage to the bone and soft tissue structures which impedes stable anchoring and joint function
• Systemic diseases and metabolic disorders
• Overload of the knee implant to be expected