Not Yet RecruitingNot Applicable

DEXA Bone Density Analysis of the CoreHip® Prosthesis System

Germany40 participantsStarted 2026-06

Plain-language summary

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.

Who can participate

Age range

35 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4)

Timeframe: within 24 months postoperative

Trial details

NCT IDNCT06632301

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Kerstin Bergmann

+49746195 info@aesculap.de

View on ClinicalTrials.gov More Primary Osteoarthritis trials

Who can participate

Age range

35 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.