Hi-Fatigue G Bone Cement Retrospective Study
This study is a look back at the experiences of patients in a single hospital who underwent total hip or total knee replacement surgery using a specific type of bone cement called Hi-Fatigue G. The main goal is to understand how well this cement has performed over the years, whether it is safe for patients, and what its benefits have been. Researchers will examine existing X-rays taken at different times during the patients' recovery to see how the implant settled. They will also look at how long the implants lasted and collect information on how patients felt after their surgery. This helps them understand the long-term success and safety of the bone cement in real-world use.
At a glance
What is this study about?
This study is called the 'Hi-Fatigue G Bone Cement Retrospective Study.' 'Retrospective' means the researchers are looking back at information already collected from patients who had total hip or total knee replacement surgery in the past at one hospital. They are specifically interested in those patients whose joint replacements were fixed in place using a special type of bone cement called Hi-Fatigue G.
The main aim of this study is to check how well this particular bone cement has worked over time. They want to confirm that it's safe and performs as expected, and that it has provided real benefits to patients. To do this, they will be reviewing patients' medical records, including X-rays taken at various points after their surgery. These X-rays help doctors see how the implant is settling into the bone.
They will also look at how long the joint replacements have lasted without needing further surgery, and any information about how patients felt and their recovery (often called 'patient reported outcomes'). This kind of study is important because it helps scientists and doctors understand the long-term effects of medical materials and procedures in a real-world setting, helping to improve future treatments.
Key takeaways
- This study reviews past patient records from hip and knee replacements.
- It focuses on a specific bone cement called Hi-Fatigue G.
- Researchers are checking how well the cement performed over time and if it was safe.
- They are looking at X-rays and patient feedback previously collected.
- No new participation or appointments are needed from patients now.
- The goal is to improve future joint replacement care.
Who may be eligible?
This study is looking at information from people who have already had either a full knee replacement or a full hip replacement. To be included, your joint replacement must have been done using a Zimmer Biomet implant and fixed with the Hi-Fatigue G Bone Cement.
You also needed to be over 18 years old when your surgery happened. Because this is a 'look-back' study, you would also have needed to agree at the time to your health information and X-rays being reviewed for research if the hospital routinely collects consent for such uses.
However, some people would not have been included. This includes if you had problems like severe muscle weakness or nerve issues in your affected leg, or if you had a known allergy to any of the materials in the bone cement. People with severe kidney problems or those who had both hips or both knees replaced at the same time were also not part of this specific review. Also, if there were concerns about a patient's ability to understand the study requirements or participate reliably, their information would not have been used.
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.
- Did you have a total hip or knee replacement?
- Was your surgery done at the hospital involved in this study?
- Was a Zimmer Biomet implant used, fixed with Hi-Fatigue G bone cement?
- Were you over 18 years old at the time of your surgery?
- Do you remember agreeing to your medical records being used for research at the time of your treatment?
What does participation involve?
As this is a 'retrospective' study, meaning it looks back at existing records, you wouldn't be asked to do anything new. All the information being used has already been collected as part of your standard care at the hospital. So, there are no extra appointments, tests, medications, or follow-up visits involved for you as a participant. The researchers are simply reviewing your past X-rays and health notes to understand how the bone cement performed over time.
Potential risks and benefits
Locations (1)
- Klinikum WeidenVerified postcodeWeiden, Germany· Recruiting
Common questions
What is 'retrospective' about this study?
It means the study looks back at information and medical records that have already been collected from patients in the past, rather than asking new patients to take part now.
What is bone cement, and why is it used?
Bone cement is a special material used in joint replacement surgery to help glue the new artificial joint firmly in place within your bone.
What does 'total hip or knee arthroplasty' mean?
This is the medical term for a total hip or total knee replacement operation, where a damaged joint is removed and replaced with an artificial one.
Will my personal details be shared?
No, your personal details will be kept private. The researchers will look at information in a way that doesn't identify you.
What are 'patient reported outcome measures (PROMs)'?
These are questionnaires or surveys that ask patients directly about how they feel, their pain levels, and how well they can do daily activities after their surgery.
How to find out more
Miguel Correa-Tapia
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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