CLUBE (UBE Stability / Dynamic Radio)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorClinique Saint Jean, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient ≥ 50 ans,

Patient requiring single-level or 2-levels lumbar decompression surgery under UBE,

Patients who underwent dynamic radiography within 3 months prior to surgery,

Patient who received information on the study and who signed the consent form.

Disqualifiers

Presence of a mobile spondylolisthesis with a ≥ 3 mm difference between flexion and extension movements on preoperative dynamic radiography,

Patient with history of lumbar arthrodesis,

Patient not available for study follow-up.

Trial design

Design model

Single group

Treatments tested in this trial

  • Postoperative dynamic radiography

    Other intervention

    Participants will perform a dynamic radiography 3 months after lumbar decompression surgery under UBE to study vertebral instability

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: postoperative dynamic radiographyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Spinal stability rate

absence of abnormal vertebral mobility

Time frame
3 months

Secondary outcomes

1

Spondylolisthesis rate

Time frame
3 months
2

Perioperative complications rate

Time frame
1 day
3

Oswestry Disability index evaluation

measure of patient incapacity improvement after surgery

Time frame
3 months
4

Pain evaluation

measure of lumbar and radicular pain improvement after surgery with visual analog scale

Time frame
3 months

Other outcomes

Sponsors and contacts

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