Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration

April 18, 2022 updated by: Peter Brehm GmbH

Prospektive, Klinische Verlaufsuntersuchung (Post Market Follow-Up) Der primären Knieendoprothese BPK-S Integration

Prospective, monocenter post market clinical follow-up of a primary knee replacement bearing the CE-mark.

200 subjects will be recruited and followed up for up to ten years or until revision of the primary knee endoprosthesis, whichever occurs first. Documentation of clinical and radiological parameters within the clinical routine pre-operative and post-operative at 3 and 12 months and 2, 5 and 10 years to evaluate time to revision, pain situation, knee functionality, mobility and stability.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

124

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
    • Niederoesterreich
      • Amstetten, Niederoesterreich, Austria, 3300
        • Landesklinikum Amstetten

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

14 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 or
  • Defects or malfunction of the knee joint or
  • Arthrosis (degenerative, rheumatic) or
  • Post-traumatic arthritis or
  • Symptomatic knee instability or
  • Reconstruction of flexibility or
  • 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
  • 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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time until revision
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement of clinical situation based on Knee Society Score
Time Frame: 3 and 12 months, 2, 5, 10 years
3 and 12 months, 2, 5, 10 years
Documentation of incidents
Time Frame: Up to 10 Years
Up to 10 Years

Collaborators and Investigators

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

Sponsor

Peter Brehm GmbH

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)

September 1, 2016

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimate)

November 26, 2015

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 18, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-02-BPK-S Integration

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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