Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
This study is checking the SYMBOL range of medical devices used in hip replacement surgery. It aims to see how safe and effective these parts are for patients over a long period, specifically 10 years. People who have conditions like hip arthritis, hip fractures, or other serious hip problems and are having a total hip replacement (either for the first time or a redo operation) using at least one SYMBOL part can take part. The goal is to make sure these devices are helping patients live better, without causing unexpected problems. This is an important step to ensure the devices used in hip surgery are working as intended.
At a glance
What is this study about?
Imagine your hip joint is like a well-oiled machine, but over time or due to an injury, it stops working properly, causing pain and difficulty moving. This is what can happen with conditions like arthritis or fractures.
When this happens, doctors might recommend a total hip replacement, where the damaged parts of your hip are removed and replaced with artificial ones. This study is specifically looking at a set of these artificial parts called the SYMBOL range. The main aim is to understand how well these SYMBOL devices work and if they are safe for people over a long period, up to 10 years after their surgery.
Researchers will be collecting information from patients who have had a hip replacement using these specific SYMBOL parts. This helps them confirm that the devices are doing their job, helping patients move better and with less pain, and that there are no unexpected problems. This kind of study is crucial to make sure that the artificial joints used are of the highest quality and benefit patients in the long run.
Key takeaways
- This study is observing how well a specific brand of hip replacement parts (SYMBOL) works.
- It's for people having either their first or a repeat hip replacement operation.
- The study will follow participants for up to 10 years.
- It aims to check the safety and effectiveness of the SYMBOL hip devices.
- Participation helps improve hip replacement outcomes for future patients.
- Your standard medical care will not change if you participate.
Who may be eligible?
To be considered for this study, you must be 18 years old or older. You also need to be having a total hip replacement surgery, either for the first time or a revision (redo) surgery, and at least one of the SYMBOL medical devices must be used during your operation. You should be able to understand and speak French.
It's important that you are willing to take part and can follow the study's instructions. If you are under legal guardianship or cannot make decisions for yourself, you won't be able to join. Also, if you've already been part of this study for a hip replacement with SYMBOL devices, you cannot join again.
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 18 years old or older?
- Are you having a total hip replacement (first time or revision)?
- Will your hip replacement use at least one SYMBOL medical device?
- Do you understand and speak French?
- Are you able to follow study instructions?
What does participation involve?
If you decide to take part, you will be followed up over a period of 10 years after your hip replacement surgery. The study involves assessing the safety and how well the SYMBOL hip replacement parts are working. This usually means that your doctors will collect information about your recovery and the health of your hip during your regular check-ups after surgery. There are no special medications involved in this study, as it’s about observing the hip replacement parts themselves. Your participation will mainly involve allowing your health information related to your hip replacement to be recorded and studied over the 10-year period.
Potential risks and benefits
Locations (9)
- Hôpital Privé de la ChâtaigneraieVerified postcodeBeaumont, France· Recruiting
- CH de Marmande - CHICVerified postcodeMarmande, France· Terminated
- Hôpital Privé du Grand NarbonneVerified postcodeMontredon-des-Corbières, France· Recruiting
- Polyclinique Grand SudVerified postcodeNîmes, France· Recruiting
- Clinique Mutualiste CatalaneVerified postcodePerpignan, France· Recruiting
- CH de PéronneVerified postcodePéronne, France· Recruiting
- Clinique MutualisteVerified postcodeSaint-Etienne, France· Recruiting
- Hôpital d'Instruction des Armées Saint-AnneVerified postcodeToulon, France· Recruiting
- Hôpital Robert Schuman - UNEOSVerified postcodeVantoux, France· Recruiting
Common questions
What is a 'total hip arthroplasty'?
This is the medical term for a total hip replacement surgery, where damaged parts of your hip joint are replaced with artificial ones.
What are 'SYMBOL medical devices'?
These are specific types of artificial hip parts (like the ball and socket) made by a company called DEDIENNE Santé, which are used in hip replacement surgery.
Why is this study important?
It helps doctors and manufacturers understand how safe and effective these specific hip replacement parts are over many years, ensuring they work well for patients.
Do I need to do anything extra if I join?
Generally, no. This study mostly involves collecting information during your existing follow-up appointments after your hip replacement surgery.
How long does the study last?
Patients in the study will be followed for a period of up to 10 years after their hip replacement surgery.
How to find out more
Marion Burland
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.