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

November 15, 2019 updated by: Peter Brehm GmbH

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Oberösterreich
      • Vienna, Oberösterreich, Austria, 1220
        • SMZ Ost, Donauspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Brehm GmbH

Collaborators

P.R.I.S.M.A.-CRO

Investigators

  • Principal Investigator: Christian E. Berger, Prof., Sozialmedizinisches Zentrum Ost - Donauspital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 20, 2018

Primary Completion (ACTUAL)

October 14, 2019

Study Completion (ACTUAL)

October 14, 2019

Study Registration Dates

First Submitted

September 19, 2017

First Submitted That Met QC Criteria

September 21, 2017

First Posted (ACTUAL)

September 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-02-BPK-S Comparison

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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