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Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration | Clinical Trials | Clareo Health

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

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

NCT02615522•Peter Brehm GmbH

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (1)

Landesklinikum Amstetten

Amstetten, Lower Austria, Austria

Key Dates

Start Date

September 1, 2016

Primary Completion Date

November 1, 2020

Completion Date

November 1, 2020

Last Updated

April 20, 2022

Enrollment

124

ACTUAL participants

Conditions

Osteoarthritis, KneeJoint Instability

Interventions

BPK-S Integration

DEVICE

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RECRUITINGPHASE3

Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans

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Nurse-Led Telehealth vs In-Person Follow-Up After Total Knee Replacement

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 20, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Probiotic Supplements in Osteoarthritis

Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans

Nurse-Led Telehealth vs In-Person Follow-Up After Total Knee Replacement

Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty

Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1

Effects of Movement Retraining on Knee Loading in Individuals With Knee Osteoarthritis