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
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Joint Instability
• Osteoarthritis, Knee

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