Clinique St Jean Sud de France
Montpellier, France
Location status: Recruiting
Location contact
Alexandre Dhenin
SUB_INVESTIGATOR
Cecile Spirito
CONTACT
Cécile SPIRITO
CONTACT
Guillaume Lonjon
PRINCIPAL_INVESTIGATOR
Matthieu VASSAL
SUB_INVESTIGATOR
NCT Number: NCT06904326
Degenerative pathologies of the spine affect a large proportion of the increasingly ageing population, and are a major public health issue. When conservative treatments (physiotherapy, analgesics, infiltrations) fail, surgical treatment is preferred.
Traditionally, a simple lumbar recalibration operation is preferred (bilateral laminectomy decompression), but this may affect spinal stability. In cases of spondylolisthesis or preoperative instability, lumbar fusion (arthrodesis) is sometimes necessary to avoid the risk of major instability, but such an operation is not without risk and may require repeat surgery.
The development of new surgical techniques such as uni or bilateral laminotomies, which are less radical, has made it possible to avoid some arthrodeses. Nowadays, the emergence of new surgical techniques such as endoscopy has further reduced the risk of destabilization (shorter post-operative convalescence, less atrophy of the paraspinal muscles) and improved surgeon comfort (better vision and easier instrument handling).
Unilateral biportal endoscopy (UBE) is one of two endoscopic techniques and has proven its effectiveness for lumbar decompression in terms of clinical benefits. However, there is no scientific evidence on spinal stability after recalibration under UBE.
We believe that minimizing invasiveness with UBE during simple lumbar recalibration surgery can preserve spinal stability, thereby reducing the need for lumbar fixation and lowering the cost of care.
We therefore propose to study the maintenance of spinal stability using dynamic radiography at 3 months post-operatively in patients undergoing lumbar recalibration surgery with UBE.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Montpellier, France
Location status: Recruiting
Alexandre Dhenin
SUB_INVESTIGATOR
Cecile Spirito
CONTACT
Cécile SPIRITO
CONTACT
Guillaume Lonjon
PRINCIPAL_INVESTIGATOR
Matthieu VASSAL
SUB_INVESTIGATOR
Spinal stability is defined by the absence of abnormal mobility (sagittal translation of at least 3 mm) between flexion and extension movements and will be assessed on the 3-months postoperative dynamic radiography.
Patients will undergone an additional dynamic radiography 3 months after surgery to assess their spinal stability.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will perform a dynamic radiography 3 months after lumbar decompression surgery under UBE to study vertebral instability
Time frame: 3 months
absence of abnormal vertebral mobility
Time frame: 3 months
Time frame: 1 day
Time frame: 3 months
measure of patient incapacity improvement after surgery
Time frame: 3 months
measure of lumbar and radicular pain improvement after surgery with visual analog scale
Time frame: 3 months
change in vertebral mobility between preoperative and postoperative dynamic radiography
Contact information is provided by the study sponsor or research team.
Clinique Saint Jean, France
Other
Assessment of Spinal Stability by Dynamic Radiography After Unilateral Biportal Endoscopic Lumbar Decompression Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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