SCORE Study: Comparing Surgery and Rigid Collar Treatment for Odontoid Fractures in Adults Over 70
The SCORE study is looking at two ways to treat a specific neck bone break (odontoid fracture) in adults aged 70 and over: surgery or wearing a rigid neck collar. These breaks can really affect how older people live their daily lives. Doctors don't currently know which treatment is best. This study will compare how well people recover, including how easily they can do everyday tasks, their pain levels, and overall quality of life, depending on which treatment they receive. Participants will be randomly assigned to one group and followed for several months to help find the best way to help older adults get back to their normal activities.
At a glance
What is this study about?
This study, called the SCORE Study, wants to find the best way to treat a specific type of broken bone in the neck for people aged 70 and older. This bone, called the odontoid, is part of your upper spine, and a break can make it hard to move your head and neck comfortably. These kinds of fractures are quite common in older adults and can really affect their ability to live independently and comfortably.
Currently, doctors aren't sure if surgery or simply wearing a stiff neck collar is the better option for these fractures in older people. Both treatments have pros and cons. The main goal of this study is to see which treatment helps people get back to their normal daily activities more effectively, like dressing themselves, eating, and moving around, after about 12 weeks. They also want to understand differences in pain, how much the break affects daily life, and overall quality of life.
To find these answers, the study will compare people who have surgery to fix the bone with those who wear a rigid neck collar. By carefully comparing both groups, the researchers hope to gather strong evidence that will help doctors make better decisions about treating these neck fractures to ensure older adults recover as well as possible, with fewer problems and a better quality of life.
Key takeaways
- Compares neck surgery vs. a neck brace for a specific neck fracture in over 70s.
- Aims to find which treatment leads to better daily living and less pain.
- Participation involves random assignment to one treatment.
- You'll have follow-up visits and fill out questionnaires for about 6 months.
- Your health will be closely monitored throughout the study.
- Your involvement helps improve care for older adults with these injuries in the future.
Who may be eligible?
This study is looking for adults who are at least 70 years old and have recently (within the last two weeks) broken a specific bone in their neck (called an odontoid fracture). Your fracture must be considered 'unstable' by the doctors.
You would not be able to join if you've already had treatment for a neck fracture before or if you have other broken bones in your neck that would need surgery at the same time. Also, if you have very serious health problems that would make surgery too risky, or if your broken neck bone is already causing serious nerve problems, you wouldn't be able to take part.
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 70 years old or older?
- Have you broken a specific bone in your upper neck (an odontoid fracture) recently (within the last 2 weeks)?
- Is your neck fracture considered 'unstable' by your doctor?
- Have you NOT had previous treatment for an odontoid fracture?
- Do you NOT have other serious broken bones in your neck requiring surgery?
- Do you NOT have very serious health conditions that would make surgery too risky, or nerve damage from the fracture?
What does participation involve?
If you join this study, you'd be randomly placed into one of two groups: either you'll have surgery to fix your neck bone, or you'll wear a rigid neck collar for about 12 weeks. You won't get to choose which treatment you receive.
After your initial treatment, you'll have follow-up visits around 12 weeks and again at 6 months. If you have surgery, you'll also have an extra check-up about two weeks afterwards. During these visits, you'll fill out questionnaires about how you're feeling, your pain, and how easily you can do daily tasks. You'll also have CT scans and other medical checks. If you're in the neck collar group, you'll be asked to keep a simple diary about when and how you use your collar. The study team will keep a close eye on you for any problems or if your treatment needs to change, for example, if you're in the collar group and doctors decide surgery is needed later on.
Potential risks and benefits
Locations (16)
- LMU University HospitalVerified postcodeMunich, Germany· Not yet recruiting
- Center for Spinal Surgery and Neurotraumatology, Berufsgenossenschaftliche UnfallklinikVerified postcodeFrankfurt am Main, Germany· Not yet recruiting
- Charité University Hospital BerlinVerified postcodeBerlin, Germany· Recruiting
- Department of Neurosurgery, RWTH Aachen UniversityVerified postcodeAachen, Germany· Not yet recruiting
- Department of Neurosurgery and Spine Center, HELIOS Hospital Berlin BuchVerified postcodeBerlin, Germany· Not yet recruiting
- Department of Orthopaedic and Traumatology, University of CologneVerified postcodeCologne, Germany· Not yet recruiting
- Department of Orthopedics, Medical University at DresdenVerified postcodeDresden, Germany· Not yet recruiting
- Department of Neurosurgery and Spine Surgery, University Hospital EssenVerified postcodeEssen, Germany· Not yet recruiting
- Department of Neurosurgery, University Medical Center GöttingenVerified postcodeGöttingen, Germany· Not yet recruiting
- Department of Trauma and Reconstructive Surgery, BG Klinikum Bergmannstrost HalleVerified postcodeHalle, Germany· Not yet recruiting
- Department of Neurosurgery, University Hospital HeidelbergVerified postcodeHeidelberg, Germany· Not yet recruiting
- Department of Neurosurgery, University Hospital of LausitzVerified postcodeLausitz, Germany· Recruiting
Common questions
What is an odontoid fracture?
It's a break in a specific small bone in your upper neck, which is quite common in older adults.
Why is this study important?
Doctors don't currently know whether surgery or a neck brace is better for this type of break in older people, so this study aims to find out.
Will I choose my treatment?
No, you'll be randomly assigned to either surgery or wearing a neck collar, like flipping a coin for fairness.
How long will the study last for me?
You'll be followed for about 6 months after your injury, with a couple of main check-up visits.
What if my condition changes during the study?
The study team will closely monitor you, and your treatment might be adjusted, even if it means moving from the collar group to surgery, if medically necessary.
How to find out more
Maria Wostrack, Prof. Dr.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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