An interventional study of Primary hip replacement with cementless stem in Primary Osteoarthritis, Cartilage Degeneration and Osteoarthritis, Hip, sponsored by Aesculap AG. Not yet recruiting at 1 site in Germany. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Aesculap AG (part of B. Braun) · Not applicable, Interventional, and Diagnostic
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.
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.
641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.
This study's planned enrollment of 40 is below the median of 90 across 457 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DEXA bone density analysis to analyze the loading concept of the CoreHip® Prosthesis System
Device: Primary hip replacement with cementless stem
Total Hip Arthroplasty is today one of the most established surgical orthopaedic procedures worldwide.
Radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4)
Changes in bone mineral density (BMD) according to Gruen.
Time frame: within 24 months postoperative
Clinical Results: Joint Function (Harris Hip Score)
The functional results of the operated hip will be assessed with the Harris Hip Score (HHS) and evaluated over time.
Time frame: preoperative, at discharge (1 week postop) and 12 months postoperative
Development of Quality of Life (EQ-5D-5L)
The EQ-5D-5L score is a generic score used to document the well-being of the patient.
Time frame: preoperative, at discharge (1 week postop) and 12 months postoperative
Development of Forgotten Joint Score
A joint-specific questionnaire with the aim to measure PRO of joint disorders . FJS is designed to measure the ability of the patient to "forget" about their problematic joint after treatment
Time frame: preoperative, at discharge (1 week postop) and 12 months postoperative
Development of Pain
The development of pain is measured with the Visual analog scale \[VAS\] a measure of pain intensity. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[on 100-mm scale\].
Time frame: preoperative, at discharge (1 week postop) and 12 months postoperative
Development of Pain
Radiological changes in the diaphyseal bone density (DEXA BMD progression over time in all Gruen Zones (Zone 1-7)
Time frame: preoperative, at discharge (1 week postop) and 12 months postoperative
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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