Not yet recruitingNAINTERVENTIONAL

Efficacy of Sub-laminar and/or Interspinous Tethers to Prevent Proximal Junctional Kyphosis After Surgical Correction of Adult Spinal Deformity

This study is investigating a common issue called Proximal Junctional Kyphosis (PJK) that can happen after spinal surgery for adults with a curved spine. PJK occurs when the spine above the surgery becomes too curved. Currently, many people need further surgery for PJK. This research is comparing two approaches: using small, flexible attachments called 'tethers' at the top of the spinal repair versus not using them. The tethers are designed to create a smoother transition between the operated and unoperated parts of the spine, hopefully reducing stress and preventing PJK. The main goal is to see if these tethers can lower the number of people who develop PJK and need another operation.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

128

Start

22 Jun 2026

Estimated completion

22 Jun 2030

Proximal Junctional Kyphosis

What is this study about?

When adults have surgery to correct their spine, a long section of their backbones (vertebrae) are often joined together, also known as a 'spinal fusion'. While this surgery can help a lot, sometimes a new problem can develop in the area just above where the fusion ends. This problem is called Proximal Junctional Kyphosis, or PJK for short, and it means that the spine above the fusion starts to curve forward too much.

PJK can be quite common, with most cases appearing within the first 18 months after surgery. If it happens, patients might need more treatment, and in some cases, even another surgery to extend the spinal fusion. This study is exploring a new way to try and prevent PJK from happening in the first place. We're looking at special, flexible bands or 'tethers' that can be placed at the very top of the spinal fusion during the initial surgery.

These tethers are thought to act like a gentle bridge, helping the spine transition smoothly from the fused part to the natural, unfused part. The aim is to reduce the stress on this delicate area and, in turn, lower the chance of PJK developing. By comparing patients who had these tethers with those who didn't, we hope to understand if this technique is effective in preventing PJK and potentially reducing the need for further surgeries.

Key takeaways

This study investigates a common problem after spine surgery called PJK.
It aims to see if special 'tethers' can prevent PJK.
The research looks at existing patient information, so no new tests or treatments are involved for participants.
Findings could help improve future spine surgery outcomes and reduce the need for further operations.

Who may be eligible?

To be part of this study, you need to be an adult (over 18 years old) who is having spinal fusion surgery. Specifically, your surgery needs to cover at least four levels of your spine, with the upper part of the fusion between your T9 and L2 vertebrae, and the lower part between your L5 and hip area.

There are certain reasons why you might not be able to join the study. For example, if you have allergies to metals, certain bone diseases, a very high body mass index (BMI over 40), or an active infection in your bones, you wouldn't be able to participate. Also, if you've had cancer recently (less than 5 years ago or currently receiving treatment) or have certain medical conditions like Parkinson's disease, severe immune problems, or serious mental health issues, you wouldn't be eligible.

Finally, if you're pregnant or breastfeeding, or if you can't understand the study details or commit to the follow-up instructions, you wouldn't be able to take part. The study also cannot include individuals who are already involved in other medical studies that might affect this research.

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 over 18 years old?
Did your spinal surgery involve at least four levels?
Was your spine fusion between T9 and L2 at the top, and L5/pelvis at the bottom?
Do you NOT have severe medical conditions like an allergy to metal, active infection, or certain bone diseases?
Are you NOT currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

This study involves looking back at the medical records of patients who have already had spinal surgery. This means you wouldn't be asked to do anything extra or different from your usual medical care. The researchers will be reviewing existing information from your past treatments to compare how well different approaches worked. You wouldn't need to visit extra clinics, take new medications, or undergo additional assessments for this study.

Potential risks and benefits

As this study is retrospective—meaning it looks at past patient data—there are no direct physical risks to participants, as no new treatments or procedures are being performed. The potential benefit is that the study's findings could help doctors better understand how to prevent complications like PJK in future patients needing spinal surgery, leading to improved care. You always have the right to withdraw your consent for your anonymised data to be used in the study at any time.

Locations (1)

Hôpital Pierre Wertheimer - Hospices Civils de Lyon, Service de Neurochirurgie - Chirurgie du Rachis et de la Moëlle Epinière
Verified postcode
Lyon, France

Common questions

What is Proximal Junctional Kyphosis (PJK)?

PJK is when the spine right above a surgical fusion starts to curve forward too much, sometimes causing discomfort or needing more surgery.

What are 'tethers'?

Tethers are small, flexible bands that can be implanted during spine surgery to help create a smoother transition between the fused and unfused parts of the spine.

Will I receive a new treatment if I join this study?

No, this study looks at information from past surgeries. You won't receive any new treatments or procedures as part of this research.

How long will this study last for me?

This study does not involve active participation. Researchers are reviewing existing medical records from your past care.

Who is running this study?

This study is being conducted by researchers in the neurosurgery department at HCL.

How to find out more

Cédric BARREY, Ph

cedric.barrey@chu-lyon.fr +33 4 72 11 80 67 Official trial record

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