Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration

Terminated

• Conditions: Osteoarthritis, Knee; Joint Instability

• Registration Number: NCT02615522
• Lead Sponsor: Peter Brehm GmbH

Brief Summary

Prospective, monocenter post market clinical follow-up of a primary knee replacement bearing the CE-mark.

200 subjects will be recruited and followed up for up to ten years or until revision of the primary knee endoprosthesis, whichever occurs first. Documentation of clinical and radiological parameters within the clinical routine pre-operative and post-operative at 3 and 12 months and 2, 5 and 10 years to evaluate time to revision, pain situation, knee functionality, mobility and stability.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-26
• Study Start: 2016-09
• Primary Completion: 2020-11
• Study Completion: 2020-11
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Congenital or acquired knee joint defects/deformation or
• Defects or malfunction of the knee joint or
• Arthrosis (degenerative, rheumatic) or
• Post-traumatic arthritis or
• Symptomatic knee instability or
• Reconstruction of flexibility or
• 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
• 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
Time until revision	10 years

Secondary Outcome Measures

Name	Time	Method
Improvement of clinical situation based on Knee Society Score	3 and 12 months, 2, 5, 10 years
Documentation of incidents	Up to 10 Years

Trial Locations

Locations (1)

Landesklinikum Amstetten; 🇦🇹 Amstetten, Niederoesterreich, Austria