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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03293719

Enrollment

Registered

2017-09-26

Start date

2018-03-20

Completion date

2019-10-14

Last updated

2019-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DEVICEBPK-S Integration UC

Primary Knee Endoprosthesis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Patient relevant benefit after 5 years	5 years	improvement of KSS-Score by at least one category as compared to preoperative basic assessment

Secondary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026