Not yet recruitingNAINTERVENTIONAL

DEXA Bone Density Analysis of the CoreHip® Prosthesis System

This study is investigating a new type of hip replacement called CoreHip®. If you're having a hip replacement because of hip arthritis, this study aims to understand how the bone around your new hip changes over the first two years after surgery. Researchers will use special X-rays, called DEXA scans, to measure your bone strength and see if the new hip causes any changes to your bone density. They are particularly interested in how your body reacts to the new hip joint. The goal is to see if the CoreHip® replacement helps maintain good bone health and to learn more about how the bone adapts to it over time. This information will help doctors understand how well this type of hip replacement works for patients.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Aesculap AG

Enrolment target

Start

01 Jun 2026

Estimated completion

01 Sep 2028

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

What is this study about?

If you're considering a hip replacement due to arthritis, this study is looking closely at a specific type of hip replacement called CoreHip®. The main goal is to understand how your bone tissue changes around the new hip joint after surgery. Doctors and researchers want to see how your body gets used to the new implant. They will use special scans to measure your bone density, which is like checking the strength of your bones, for up to two years after your operation.

The researchers are specifically interested in how the bone in certain areas, close to where the hip replacement sits, reacts. They want to make sure the bone stays strong and healthy. They also want to understand if the new hip changes how weight and stress are spread across your hip bone, which is something called 'stress shielding'. Learning about these changes can help doctors in the future choose the best hip replacements for patients with arthritis.

This study is important because it helps improve our understanding of how modern hip replacements work in the long term. By carefully monitoring patients, doctors can gain valuable insights that could lead to better surgical outcomes and improved quality of life for people needing hip replacements.

Key takeaways

This study evaluates a specific hip replacement called CoreHip®.
It aims to understand bone changes around the hip over two years.
DEXA scans will be used to measure bone strength.
Participation involves extra check-ups and scans after surgery.
No extra medication or surgery is required for the study.

Who may be eligible?

This study is looking for people between 35 and 85 years old who are having their first hip replacement on one side because of hip arthritis. The type of hip replacement needs to be the CoreHip® Standard stem, as decided by your surgeon.

There are also some reasons why you might not be able to join. For example, if you're pregnant, have a very high body mass index (BMI over 35), or have a history of broken bones in the same hip. You also can't join if you have certain bone conditions that affect how your bones grow or change, or if you're taking medicines that affect your bones, like certain steroids.

If you have severe arthritis in your other hip, or if you've had a hip replacement on the other side, or anything else that might make it hard for you to put weight on your hip during the study, you probably wouldn't be able to take part. The study team will need to make sure you can come to all the follow-up appointments and understand what's involved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you having your first hip replacement on one side?
Is your hip replacement for arthritis?
Are you between 35 and 85 years old?
Do you not have a very high BMI (over 35)?
Have you not had a recent hip fracture or surgery on the same hip?
Are you able to attend follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will have your hip replacement surgery as planned with the CoreHip® system. In addition to your usual check-ups, you'll have extra bone density scans (DEXA scans) to measure your bone health around the new hip. These scans will happen at certain times after your surgery, usually within the first two years. The exact number and timing of visits will be explained by the study team. You won't be taking any extra medication as part of this study; it's all about observing how your body responds to the standard hip replacement. The total duration of your active involvement in the study will be up to 24 months after your surgery.

Potential risks and benefits

Taking part in this study means doctors can learn more about how the CoreHip® hip replacement works, which could help future patients. The main benefit to you is that your bone health around the hip replacement will be closely monitored with extra DEXA scans, providing detailed information that wouldn't normally be collected during routine care. There are no additional medical risks from the hip replacement itself, as you would be having the surgery anyway. The DEXA scans involve a very small amount of radiation, similar to a regular X-ray, which is generally considered safe. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Medizinische Hochschule Hannover
Verified postcode
Hanover, Germany

Common questions

What is a DEXA scan?

A DEXA scan is a special type of X-ray that measures the strength and density of your bones. It's often used to check for conditions like osteoporosis (bone thinning).

Will I have more surgery if I join this study?

No, you will only have the hip replacement surgery you were already scheduled for. The study doesn't involve any extra surgery.

Do I have to take any new medicines for this study?

No, this study doesn't involve taking any new medications. It's about observing how your body responds to the hip replacement.

How long will I be followed for if I join?

You will be followed for up to 24 months (two years) after your hip replacement surgery.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and it won't affect the care you receive from your doctors.

How to find out more

Kerstin Bergmann

info@aesculap.de +49746195 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.