Health TrialsbyHealthPanel

Vertebropexy - Randomized-controlled Trial

ConditionsDegenerationSpinal StenosisFusion of Spine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBalgrist University Hospital

About this trial

To assess the need for additional fusion surgery versus the risk of a revision surgery in patients with degenerative lumbar spinal disease and to assess efficacy and risk of the ligamentous fixation technique (vertebropexy)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Single-level or two-level lumbar surgery needed

Indication for decompression surgery in patients with spinal canal stenosis and additional stable degenerative listhesis (without facet joint effusion ≥ 2mm)

Indication for fusion surgery in patients with spinal canal stenosis and additional unstable degenerative listhesis (facet joint effusion ≥ 2mm), in patients with foraminal stenosis and additional degenerative listhesis, and in patients with segment degeneration of the disc

Disqualifiers

Indication for decompression and/or fusion surgery in patients with solely disc herniation, fractures, lytic listhesis, tumor

Patients undergoing revision surgery for infection

Patients undergoing revision surgery on the same level if bony structures have been removed (e.g. prior laminectomy or midline decompression)

Patients undergoing revision surgery in case of prior fusion surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vertebropexy

    Procedure/Surgery

    microsurgical (i.e., the use of a microscope or magnifying glasses during decompression) lumbar laminotomy with partial removal of the medial facet joint by preserving the midline structures (supraspinous-interspinous ligament complex); approach: bilateral or ipsilateral with cross-over to the contralateral side. Additional stabilization of the spine with a ligament (for instance semitendinosus donor allograft), which connect the postoprior structures (Proc. Spinosus and/or Lamina) of the vertebrae . Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia)

Treatment groups

164 Participants
are divided into 4 treatment groups
Group A: Indication for decompression, randomization for decompressionActive comparator 1 intervention
Group B: Indication for decompression, randomization for vertebropexyExperimental treatment 1 intervention
Group C: Indication for fusion, randomization for fusionActive comparator 1 intervention
Group D: Indication for fusion, randomization for vertebropexyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ODI (Oswestry Disability Index)

To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery

Time frame
2 years postoperative

Secondary outcomes

1

VAS (Visual Analogue Scale)

To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery. VAS scale 0-10, 10 meaning the highest pain score and 0 no pain at all.

Time frame
2 years postoperative
2

SSM symptoms/function (Spinal Stenosis Measure)

To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery

Time frame
2 years postoperative
3

SSM satisfaction (Spinal Stenosis Measure)

To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery

Time frame
2 years postoperative
4

EQ-5D (European Quality of Life Five Dimension)

To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery

Time frame
2 years postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Balgrist University Hospital

Lead sponsor

Source ClinicalTrials.gov
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