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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03293719
Other study ID # 2017-02-BPK-S Comparison
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 20, 2018
Est. completion date October 14, 2019

Study information

Verified date November 2019
Source Peter Brehm GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Prospective Post-Market Clinical Follow up study according to MEDDEV 2.12/2 rev2 of the European Union. Patients receiving the primary knee implant BPK-S UC as primary implant in either variant ceramic or CoCr (metal) are eligible for the study and will be followed up for 5 years after implantation or until revision of the prosthesis, whichever occurs first. Demographic data will be collected together with data regarding safety and benefit at defined timepoints (preoperative, intraoperative and at 3 months, 1 year, 2 years and 5 years after implantation).

Patients will be divided in 2 cohorts (ceramic and metal) and stratified by age.


Recruitment information / eligibility

Status Terminated
Enrollment 28
Est. completion date October 14, 2019
Est. primary completion date October 14, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Congenital or acquired knee joint defects/deformation

- Defects or malfunction of the knee joint

- Arthrosis (degenerative, rheumatic)

- Post-traumatic arthritis

- Symptomatic knee instability

- Reconstruction of flexibility

- 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

- Pregnancy

- 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


Intervention

Device:
BPK-S Integration UC
Primary Knee Endoprosthesis

Locations

Country Name City State
Austria SMZ Ost, Donauspital Vienna Oberösterreich

Sponsors (2)

Lead Sponsor Collaborator
Peter Brehm GmbH P.R.I.S.M.A.-CRO

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient relevant benefit after 5 years improvement of KSS-Score by at least one category as compared to preoperative basic assessment 5 years
Secondary Patient relevant benefit as measured by American Knee Society Score improvement of KSS-Score as compared to preoperative basic assessment 3 months, 1, 2 and 5 years
Secondary Patient relevant benefit as measured by Knee Osteoarthritis Outcome Score Improvement of KOOS as compared to preoperative basic assessment 3 months, 1, 2 and 5 years
Secondary Patient Quality of Life Improvement of EQ-5D as compared to preoperative basic assessment 3 months, 1, 2 and 5 years
Secondary Implant Loosening Number Number of implant loosening due to quality issues with the implant 3 months, 1, 2 and 5 years
Secondary Implant Loosening Reason Reason for implant loosening due to quality issues with the implant 3 months, 1, 2 and 5 years
Secondary Revision Number Number of revisions, if required 3 months, 1, 2 and 5 years
Secondary Revision Reason Reason for revision, if required 3 months, 1, 2 and 5 years
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