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

Sponsor

Peter Brehm GmbH (Industry)

Overall Status

Terminated

CT.gov ID

NCT03293719

Collaborator

P.R.I.S.M.A.-CRO (Other)

Enrollment

Location

18.8

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Osteoarthritis, Knee Joint Instability Arthritis Joint Disease Musculoskeletal Disease Rheumatic Diseases	Device: BPK-S Integration UC

Study Design

Study Type:

Observational

Actual Enrollment :

28 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Mar 20, 2018

Actual Primary Completion Date :

Oct 14, 2019

Actual Study Completion Date :

Oct 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Ceramic Patients receiving BPK-S Integration UC implant made from BIOLOX delta ceramic	Device: BPK-S Integration UC Primary Knee Endoprosthesis
CoCr Patients receiving BPK-S Integration UC implant made from CoCr (metal)	Device: BPK-S Integration UC Primary Knee Endoprosthesis

Arm

Intervention/Treatment

Ceramic

Patients receiving BPK-S Integration UC implant made from BIOLOX delta ceramic

Device: BPK-S Integration UC

Primary Knee Endoprosthesis

CoCr

Patients receiving BPK-S Integration UC implant made from CoCr (metal)

Device: BPK-S Integration UC

Primary Knee Endoprosthesis

Outcome Measures

Primary Outcome Measures

Patient relevant benefit after 5 years [5 years]
improvement of KSS-Score by at least one category as compared to preoperative basic assessment

Secondary Outcome Measures

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
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
Implant Loosening Reason [3 months, 1, 2 and 5 years]
Reason for implant loosening due to quality issues with the implant
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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