Post-market Follow up Study of the 'BPK-S Integration' UC... | NCT03293719

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Monocentric Study, Site reorganised, could no longer participate in study

Expanded Access Info

Start Date

Mar 20, 2018Actual

Primary Completion Date

Oct 14, 2019Actual

Completion Date

Oct 14, 2019Actual

First Submitted Date

Sep 19, 2017

First Submission Date that Met QC Criteria

Sep 21, 2017

First Posted Date

Sep 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2019

Last Update Posted Date

Nov 19, 2019Actual

Name	Class
P.R.I.S.M.A.-CRO	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ceramic		Patients receiving BPK-S Integration UC implant made from BIOLOX delta ceramic	Device: BPK-S Integration UC
CoCr		Patients receiving BPK-S Integration UC implant made from CoCr (metal)	Device: BPK-S Integration UC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BPK-S Integration UC	Device	Primary Knee Endoprosthesis	Ceramic CoCr

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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
Patient relevant benefit as measured by Knee Osteoarthritis Outcome Score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing primary total knee endoprosthesis with BPK-S Integration of age 18 and older

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian E. Berger, Prof.	Sozialmedizinisches Zentrum Ost - Donauspital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SMZ Ost, Donauspital		Vienna	Upper Austria	1220	Austria

ID	Term
D010003	Osteoarthritis
D020370	Osteoarthritis, Knee
D007593	Joint Instability
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases