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CoreHip - Post Market Clinical Follow-Up Study

NCT ID: NCT03685110

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

248 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-16

Study Completion Date

2028-12-31

Brief Summary

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The study is designed as a prospective, non-interventional multicentre cohort study. The product under Investigation will be used in Routine clinical practice and according to the authorized Instructions for Use (IfU). Aim of this observational study is to collect clinical and radiological results of the CoreHip® endoprosthesis system in a Standard Patient Population and when used in Routine clinical practice.

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Detailed Description

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The CoreHip® System has a range of different stem designs to address most of the indications and anatomical conditions met in Primary THA patients within one implant and Instrument System.

Conditions

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Degenerative Osteoarthritis Rheumatic Arthritis Fractures, Hip Necrosis, Femur Head

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CoreHip

Clinical and Radiological Data of 300 patients of a Standard Patient Population, who are treated with CoreHip Total Hip Arthroplasty for Indications according to the Instructions for Use (IfU) with a five year follow Up

CoreHip Total Hip Arthroplasty

Intervention Type DEVICE

Replacement of the Hip Joint

Interventions

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CoreHip Total Hip Arthroplasty

Replacement of the Hip Joint

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient age ≥ 18 years
* Indication for THA with a CoreHip® stem
* Written informed consent

Exclusion Criteria

* Pregnancy
* Patient age \< 18 years
* Patient not able to regularly participate at the follow-up examinations
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henning Windhagen, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Orthopädische Kliniken im Annastift, Medizinische Hochschule Hannover

Locations

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Ortrhopädische Klinik Markgröningen

Markgröningen, Baden-Wurttemberg, Germany

Site Status

Orthopädische Chirurgie München

München, Bavaria, Germany

Site Status

MHH

Hanover, Lower Saxony, Germany

Site Status

St. Josefs Krankenhaus Endoprothetik Zentrum

Salzkotten, , Germany

Site Status

Spital Brig

Brig, , Switzerland

Site Status

Luzerner Kantonsspital Sursee

Sursee, , Switzerland

Site Status

Countries

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Germany Switzerland

Other Identifiers

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AAG-O-H-1509

Identifier Type: -

Identifier Source: org_study_id

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