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New surgical trick may stop spine from bending after major back surgery
NCT ID NCT07618897
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding flexible bands (tethers) at the top of a spinal fusion can prevent a common complication called proximal junctional kyphosis (PJK), where the spine curves forward above the surgical site. About 128 adults undergoing spinal fusion for deformity will be randomly assigned to receive either standard surgery alone or standard surgery plus the bands. Researchers will track how many people develop PJK within two years after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sub-laminar and/or interspinous tethers (flexible bands implanted during spine surgery)
- What this could lead to
- If it works, this could reduce the need for repeat surgeries after spinal fusion by preventing a common complication where the spine curves abnormally above the surgical site.
- What could go wrong
- This is a relatively small, early-stage trial (128 participants) and the complication it aims to prevent is not guaranteed to happen. The bands may not work as hoped, and there are always risks with any surgery, such as infection or band malposition.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 128 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient men and women older than 18 * Patient indicated spinal posterior fusion and instrumentation with the upper end (UIV with screws) between T9 and L2 and the lower end between L5 and iliac * Constructs ≥4 levels (i.e., ≥4 discs included) * Patient able to signed a consent form * Patient able to fill a self-administered questionnaire * Patient affiliated to health care insurance (social security in France Exclusion Criteria: * Allergy to metal * Cimentoplasty at the junctional zone (UIV, UIV+1 and/or UIV+2) * Bone metabolism disorders that potentially compromise the mechanical support expected from this type of implant. * Morbid obesity (BMI \> 40) * Patients with infection (in particularly osteomyelitis) * Cancer of lesss than 5 years or currently treated * Acute trauma * Immunodepression * Parkinson * Chronic inflammatory disease * Severe psychological disorders * Pregnancy or women breastfeeding * Inadequate tissue coverage of implant site, * Interference with other critical anatomical structures. * Patient not being able to understand the objectives of the study or refusing to comply with postoperative instructions * Patient participating in an ongoing study that may interfere with this study * Patient under legal protection
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hôpital Pierre Wertheimer - Hospices Civils de Lyon, Service de Neurochirurgie - Chirurgie du Rachis et de la Moëlle Epinière
Lyon, 69394, France
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