DEXA Bone Density Analysis of the CoreHip® Prosthesis System

NCT ID: NCT06632301

Last Updated: 2025-08-14

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-05-31

Brief Summary

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The goal of this interventional post-market follow-up study is to evaluate radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4) within 24 months postoperative in patients treated with CoreHip® primary cementless stem. The DEXA bone density analysis is used.

Detailed Description

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Additional diagnostic examination: DEXA-Analysis. A DEXA scan is an imaging test that measures bone density (strength). The results can provide helpful details about risk for osteoporosis (bone loss) and fractures. Furthermore we would like to find out more about stress shielding processes around our prosthesis.

Conditions

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Primary Osteoarthritis Cartilage Degeneration Osteoarthritis, Hip Inflammatory Arthritis Osteonecrosis of Femoral Head Traumatic Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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DEXA

DEXA bone density analysis to analyze the loading concept of the CoreHip® Prosthesis System

Group Type EXPERIMENTAL

Primary hip replacement with cementless stem

Intervention Type DEVICE

Total Hip Arthroplasty is today one of the most established surgical orthopaedic procedures worldwide.

Interventions

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Primary hip replacement with cementless stem

Total Hip Arthroplasty is today one of the most established surgical orthopaedic procedures worldwide.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Unilateral hip osteoarthritis
* Indication for CoreHip Standard hip stem according to preoperative planning
* Written Informed Consent
* Age 35-85 years
* According to the assessment of the study doctor, the patient is therapy compliant and able to attend the follow-up visits

Exclusion Criteria

* Femoral neck fractures
* Pregnancy
* BMI \> 35
* History of femoral fracture or previous surgery on the same hip
* Metabolic bone disease, use of steroids or other drugs affecting bone metabolism
* Intraoperative bone cracks
* Severe osteoarthritis of the contralateral hip
* THA of the contralateral side or other event leading to restricted weight bearing during the study period
Minimum Eligible Age

35 Years

Maximum Eligible Age

85 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.

Role: PRINCIPAL_INVESTIGATOR

Orthopädische Kliniken im Annastift, MHH

Locations

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Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Countries

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Germany

Central Contacts

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Kerstin Bergmann

Role: CONTACT

+49746195 ext. 0

Stefan Maenz

Role: CONTACT

0746195 ext. 0

Facility Contacts

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Henning Windhagen

Role: primary

Other Identifiers

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AAG-G-H-23009

Identifier Type: -

Identifier Source: org_study_id

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