Post-market clinical follow-up study for Zimmer femoral nails
This study is checking how safe and effective two types of Zimmer Natural Nails are for fixing broken thigh bones (femur). These nails are metal rods placed inside the bone to help it heal properly. Researchers will look at existing patient records and speak to patients about their recovery. If you've already had surgery with one of these nails and meet certain health requirements, you might be invited to participate. This involves answering questions about your pain and how well your hip or knee works over the phone, and allowing researchers to review your medical notes. There are no direct benefits or risks to you, but your input will help improve future care for others with similar injuries.
At a glance
What is this study about?
Imagine you've broken your thigh bone, also known as your femur. Often, doctors use a special metal rod, called a femoral nail, to help hold the bone in place while it heals. This study, called a 'post-market clinical follow-up', is designed to look closely at two specific types of these nails, manufactured by Zimmer, to make sure they are working well and safely for patients.
The main aim is to understand how these Zimmer Natural Nails perform in real-world situations, after they've been approved for use. The study will gather information from people who have already had these nails fitted due to a broken thigh bone. By doing this, the researchers can confirm how effective the nails are at helping people recover and whether there are any unexpected issues. This information is really important because it helps doctors and manufacturers ensure the best treatment for future patients.
So, think of it as a quality check. The study team isn't trying out a new treatment; they're simply gathering detailed information on treatments that are already in use. Your participation would help medical teams understand more about the long-term success of these operations, leading to better care for people with similar injuries in the future.
Key takeaways
- The study checks how well Zimmer femoral nails work for broken thigh bones.
- It involves reviewing your past medical records and a simple phone call.
- You won't get any new treatment or extra tests.
- There are no direct benefits or risks to you.
- Your information helps improve future care for others.
- You can decide not to take part at any time.
Who may be eligible?
You might be able to take part in this study if you have already had surgery to fix a broken thigh bone using either the Zimmer Antegrade Femoral Nail or the Zimmer Retrograde Femoral Nail. These nails would have been used to help stabilise your thigh bone while it healed.
However, some conditions mean you cannot take part. For example, if the nail was used for something other than a typical thigh bone break, or if you had an infection in your bone before surgery. People with very poor bone quality, certain other medical conditions, or those under 18 years old cannot participate. Also, if you’ve previously told the NHS that you don’t want your health data shared for research, you won't be able to join.
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.
- Have I had a broken thigh bone (femur) treated with a metal nail?
- Was the nail specifically a Zimmer Antegrade or Retrograde Femoral Nail?
- Am I 18 years old or older?
- Have I not previously opted out of sharing my health data for research nationally?
- Do I generally have good bone quality and no severe underlying health conditions that would affect the implant?
What does participation involve?
If you might be suitable for the study, you'll first get a letter with more information. About three to four weeks after that, a member of the study team will call you to answer any questions you have. If you decide you'd like to take part, you'll simply give your agreement over the phone. After that, the team will ask you a few questions during the same call about any pain you might have and how well your hip or knee is working. They will also look back at your existing medical records, including details of your surgery, X-rays, and any related problems. There are no hospital visits, extra appointments, or new medications involved. The study will run from 10 March 2025 to 31 January 2026, though your individual involvement will be a single phone call and record review.
Potential risks and benefits
Locations (1)
- East Kent Hospitals University NHS Foundation TrustCity onlyCanterbury, England
Common questions
What is a 'femoral nail'?
A femoral nail is a metal rod put inside your thigh bone (femur) to hold it steady while it heals after a break.
Will I have to go to the hospital?
No, you won't need to visit the hospital for this study. All your involvement will be over the phone and through reviewing your existing medical records.
Will my information be kept private?
Yes, all your information will be stored securely, and only the study team will be able to access it for the purpose of the study.
Who is paying for this study?
The study is being funded by Zimmer Biomet, a company based in the USA that makes medical devices.
Can I say no to taking part?
Absolutely. Taking part is completely voluntary. If you choose not to, or if you change your mind later, it will not affect your medical care in any way.
How to find out more
Raman Thakur
Always speak to your GP or specialist before deciding to take part in a study.
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