All studies
Active not recruitingNAINTERVENTIONAL

Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection

This study is investigating a new way to treat infections that can happen around hip replacements. Normally, if a hip replacement gets infected, patients need two separate operations. The first removes the infected parts and patients go without an implant for weeks while taking antibiotics, before a second surgery puts in new parts. This can be tough, causing discomfort and limiting movement. This study is exploring a single operation where the new hip replacement is put in right away, but with a special coating designed to stop infection-causing bacteria from settling on the implant. The aim is to see if this single surgery, with the coated implant, is as good as, or better than, the traditional two-surgery method, potentially making recovery quicker and easier for patients.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrolment target
39
Start
30 Sep 2021
Estimated completion
01 Dec 2026

What is this study about?

When someone has a hip replacement, sometimes an infection can develop around the new joint. This can be a very challenging problem to treat. The usual approach involves two separate operations. First, the infected hip replacement parts are removed, and antibiotics are given, often for at least six weeks. During this time, patients don't have a new hip joint, which can be uncomfortable and make it hard to move around properly. Only then, in a second operation, are new hip replacement parts put in. This whole process means two hospital stays and a long recovery period.

This study is looking at a different approach: a single operation. In this single surgery, the infected parts are removed, and a brand new hip replacement is put in straight away. The key difference here is that the new hip replacement will have a special coating on it. This coating is designed to help prevent bacteria from sticking to the implant and forming a protective layer, which is how they often cause ongoing infections. If this single-stage surgery with the coated implant works well, it could mean a shorter time in hospital, less discomfort, and a quicker return to normal activities for patients.

The main goal of this research is to see if this single-stage surgery with the special coated implant is as effective as, or even better than, the current two-stage approach in getting rid of the infection for good. The hope is to find a simpler, more efficient way to help people who experience this kind of hip replacement infection.

Key takeaways

  • Exploring a new single-surgery approach for hip replacement infections.
  • Compares single surgery with a special coated implant to the usual two-stage method.
  • Aims for a quicker recovery and fewer hospital stays.
  • Special implant coating helps prevent bacteria from clinging to the new hip.
  • Addresses a common and challenging problem after hip replacements.
  • Could offer a more effective and patient-friendly treatment option.

Who may be eligible?

To be able to take part in this study, doctors will check if you meet certain requirements. You would need to be covered by social security and be willing to sign a consent form, showing you understand the study and agree to participate. The study is specifically for adults aged 18 or older who have a chronic hip joint infection around their hip replacement.

There are also reasons why you wouldn't be able to join. For example, if you are pregnant or might be pregnant, or if you are allergic to any of the materials in the special coating used on the implant. People with a very short life expectancy (less than 3 months) or who are unable to fully understand and agree to the study will also not be able to participate. Also, if the surgical team plans to use a specific type of cemented implant that is not part of the study, you would not be eligible.

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.

  1. Am I 18 years old or older?
  2. Do I have an active hip joint infection around my hip replacement?
  3. Am I not pregnant and don't plan to be during the study?
  4. Am I not allergic to any materials found in the special implant coating?
  5. Do I expect to live longer than 3 months?
  6. Am I able to fully understand and agree to take part in a study?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo a single surgery where your infected hip replacement is removed, and a new one with a special anti-infection coating is put in during the same operation. After the surgery, you would have regular check-ups and assessments, which might include blood tests and possibly other scans, to monitor how you are recovering and to make sure the infection has gone. The total duration of follow-up visits and assessments will be explained by the study team, but it's designed to track your progress and health for an extended period.

Potential risks and benefits

Potential benefits of taking part might include the chance of a quicker recovery with fewer surgeries and hospital stays compared to the standard treatment. The special coating on the implant aims to reduce the risk of the infection coming back. However, as with any surgery, there are potential risks, such as general complications from surgery, difficulties with the new implant, or the infection not clearing up completely. You would be fully informed about all potential risks and benefits. Remember, you have the right to withdraw from the study at any time without affecting your future medical care.

Locations (14)

  • CHU Amiens
    Verified postcode
    Amiens, France
  • CHU Bordeaux
    Verified postcode
    Bordeaux, France
  • CHU Caen
    Verified postcode
    Caen, France
  • CHU Clermont-Ferrand
    Verified postcode
    Clermont-Ferrand, France
  • CHU Dijon
    Verified postcode
    Dijon, France
  • CHU Lille
    Verified postcode
    Lille, France
  • HCL - Hôpital de la Croix Rousse
    Verified postcode
    Lyon, France
  • HCL - Hôpital Edouard Herriot
    Verified postcode
    Lyon, France
  • CHU Marseille
    Verified postcode
    Marseille, France
  • CHU Nancy
    Verified postcode
    Nancy, France
  • CHU Nantes
    Verified postcode
    Nantes, France
  • CHU Nice
    Verified postcode
    Nice, France

Common questions

What is a 'hip prosthesis infection'?

It's when bacteria cause an infection around an artificial hip joint that has been put in during a hip replacement operation.

What does 'single-stage surgery' mean?

It means all the necessary surgery, like removing the infected parts and putting in a new hip replacement, happens in one operation.

What is the 'Defensive Antiadhesive Coating (DAC)®'?

It's a special coating on the new hip replacement that helps stop bacteria from sticking to the implant and causing an infection.

Why is this study important?

It's trying to find a simpler, potentially quicker and more effective way to treat these difficult hip replacement infections, which could improve recovery for patients.

Will I still need antibiotics if I have a coated implant?

Yes, even with the special coating, antibiotics are still an important part of treating an infection, and the coating also slowly releases antibiotics over time.

How to find out more

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

Discussion

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