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NCT02615522 Clinical Trial

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

Osteoarthritis, Knee Clinical Trial

Official title:
Prospektive, Klinische Verlaufsuntersuchung (Post Market Follow-Up) Der primären Knieendoprothese BPK-S Integration

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02615522
Other study ID # 2015-02-BPK-S Integration
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 2016
Est. completion date November 2020

Study information
Verified date April 2022
Source Peter Brehm GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 124
Est. completion date November 2020
Est. primary completion date November 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• BPK-S Integration

Locations
Country Name City State
Austria Landesklinikum Amstetten Amstetten Niederoesterreich

Sponsors (1)
Lead Sponsor Collaborator
Peter Brehm GmbH

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time until revision 10 years
Secondary Improvement of clinical situation based on Knee Society Score 3 and 12 months, 2, 5, 10 years
Secondary Documentation of incidents Up to 10 Years
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