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

NCT ID: NCT02615522

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 124 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-11-30

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.

Conditions

Osteoarthritis, Knee; Joint Instability

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

BPK-S Integration

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peter Brehm GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Landesklinikum Amstetten

Amstetten, Lower Austria, Austria

Countries

Austria

Other Identifiers

2015-02-BPK-S Integration

Identifier Type: -

Identifier Source: org_study_id