RecruitingOBSERVATIONAL

Prospective Validation Study of the CD8+TEMRA Cells As a Prognostic Biomarker of Healing Outcome After Fracture

Broken bones usually heal well, but for about 10-15% of people, healing can be slow or stop altogether, leading to more operations and longer recovery. Currently, there's no easy way to tell in advance who might have these healing problems. This study is trying to find out if a specific cell in your blood, called a CD8+TEMRA cell, can act as an early warning sign. If doctors can identify patients at risk before their first operation, they can offer extra treatments to help the bone heal better from the start. This could mean a quicker recovery and less need for further surgery, making a big difference to patients and the healthcare system.

At a glance

Status

Recruiting

Sponsor

Charite University, Berlin, Germany

Enrolment target

640

Start

01 Dec 2016

Estimated completion

01 Jun 2025

Fracture Non Union Fracture Healing Long Bone Delayed-Union Fracture Humerus Shaft Fracture Forearm Fracture Femoral Neck Fractures Femur Distal Fracture Pertrochanteric Fracture of Femur Femoral Shaft Fracture Proximal Tibia Fracture Tibial Shaft Fracture Distal Tibia Fracture

What is this study about?

Broken bones, like those in your leg or arm, usually heal up over time. But for some people, perhaps 1 in 10 or 1 in 7, the healing process takes a long time or stops completely. When this happens, it's called a 'non-union' or 'delayed union,' and it can be really tough. Patients might need more operations, spend more time in hospital or rehab, and be unable to work, which affects their lives and puts a strain on the NHS.

Right now, doctors can't reliably tell who these patients will be before they have their initial surgery. This means that treatments to boost healing are often only given much later, after it's clear there's a problem. This study is hoping to change that by finding an 'early warning' sign in your blood.

Researchers are looking at a specific type of cell called a CD8+TEMRA cell. They believe that by checking the levels of these cells in your blood before surgery, they might be able to predict whether your bone will heal normally, slowly, or not at all. If this blood test works, it would allow doctors to offer tailored treatments sooner to those who need them most, potentially helping bones heal better and avoiding future complications and surgeries.

Key takeaways

Aims to find an early warning sign in blood for slow bone healing.
Could help doctors offer personalised treatments sooner.
Involves a blood test and your routine follow-up appointments.
Does not change the treatment you receive during the study.
Could improve care for future patients with broken bones.

Who may be eligible?

This study is looking for both men and women who are between 18 and 80 years old. You might be suitable if you have a broken bone that hasn't broken through the skin (a 'closed fracture') in your arm, forearm, thigh, or lower leg.

Only people who have broken just one bone, or whose injury is similar to breaking just one bone, and who are having surgery to fix it, will be included. You also need to be able to understand and sign a consent form, showing you agree to take part.

However, some people will not be able to join. This includes if your break is due to cancer, if it's around an artificial joint, or if you have certain serious illnesses like active hepatitis B or C, HIV, severe inflammatory diseases like Crohn's, or certain types of cancer or mental health conditions. If you've had a bone marrow or organ transplant, or certain cell therapies recently, or if you're pregnant, you also can't take part. The study also can't include anyone already in another clinical trial or if the doctor thinks you're not suitable for other reasons.

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 between 18 and 80 years old?
Do you have a broken arm, forearm, thigh, or lower leg bone?
Is your fracture 'closed' (not broken through the skin)?
Are you having surgery to fix your broken bone?
Do you have any serious long-term illnesses like active Hepatitis or severe inflammatory conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is a blood test when you arrive at the hospital for your initial broken bone surgery. This blood sample will be used to check for the special CD8+TEMRA cells. Apart from this, all your other visits will be part of your usual check-ups, including X-rays or CT scans, and physical examinations to see how your bone is healing and how you're recovering overall. You'll also complete a questionnaire about your quality of life called the SF-36.

Researchers will be looking at your healing progress at a couple of key points: between 17 and 19 weeks after your operation to see if healing is delayed, and then again between 34 and 36 weeks after your operation to check for complete non-union (where the bone hasn't healed at all). The doctors looking after you won't know the results of your special blood test at the time, so it won't affect your treatment during the study. This setup helps ensure the study results are reliable.

Potential risks and benefits

Taking part in this study could help future patients with broken bones, as finding an early prediction method can lead to better, more personalised treatments. For you, the direct benefits are limited as the test results won't influence your treatment during the study. However, you'll receive careful monitoring of your healing process through your routine check-ups. The main risk involves the blood tests, which might cause minor discomfort, bruising, or a very small risk of infection, similar to any routine blood draw. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (7)

Clinic for Trauma, Hand and Reconstructive Surgery University Hospital Münster (UKM)
Verified postcode
Münster, Germany· Recruiting
University Hospital University Centre for Orthopaedics and Trauma Surgery Dresden
Verified postcode
Dresden, Germany· Recruiting
University Hospital Clinic and Polyclinic for Orthopaedics, Trauma Surgery and Plastic Surgery Leipzig
Verified postcode
Leipzig, Germany· Recruiting
Unfallkrankenhaus Berlin
Verified postcode
Berlin, Germany· Recruiting
Charité Universitätsmedizin Berlin, Centre for Musculoskeletal Surgery (CMSC)
Verified postcode
Berlin, Germany· Recruiting
Vivantes Klinikum Spandau Berlin
Verified postcode
Berlin, Germany· Recruiting
Clinic for Orthopaedics and Trauma Surgery Jena/Eisenberg
Verified postcode
Eisenberg, Germany· Recruiting

Common questions

What is a CD8+TEMRA cell?

It's a type of immune cell found in your blood. This study is exploring if its levels can tell us something about how well your broken bone might heal.

Will this study affect my treatment for the broken bone?

No, the results of the special blood test will not be known to your doctors during the study, so it won't change the care you receive for your fracture.

What is 'non-union'?

Non-union means that a broken bone has completely failed to heal and join back together after a normal healing time.

How long will I be involved in the study?

You'll be followed for about 34 to 36 weeks after your operation to see how your bone heals over time, mostly through your regular hospital visits.

Do I have to pay to be part of this study?

No, you will not have to pay to participate in this study. All study-related procedures that are not part of your standard care are covered by the researchers.

How to find out more

Simon Reinke, Phd

simon.reinke@bih-charite.de +49 (0)30-450-659617 Official trial record

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