Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr or Ceramic

Osteoarthritis Clinical Trial

Official title:

Prospective, Open, Non-randomized, Non-interventional Explorative, Comparative, Uncontrolled Cohort Study for Post Market Clinical Follow-Up of the "BPK-S Integration" UC in the Variants CoCr or Ceramic as Primary Implant

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03293719
• Other study ID #: 2017-02-BPK-S Comparison
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Arthritis
• Collagen Diseases
• Joint Disease
• Joint Diseases
• Joint Instability
• Musculoskeletal Disease
• Musculoskeletal Diseases
• Osteoarthritis
• Osteoarthritis, Knee
• Rheumatic Diseases

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