Vertebropexy - Randomized-controlled Trial

Study Overview
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Brief Summary
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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 a new ligamentous fixation technique (vertebropexy)

Detailed Description
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The global share of people over the age of 65 years has been consistently on the rise over the past few decades, and is still projected to increase. The increasing life expectancy, overall advances in medical care and therefore, the higher average age of people seeking surgical treatment lead to increasing numbers of spine surgeries: Spinal fusion is one of the most frequently used surgical treatment modalities for spinal disorders with 7.6 million per year worldwide (EU: 700,000, USA: 450,000, CH: 9000) and provides stability by internal rigid fixation of the spine with screws, rods and bony fusion. Although producing reliable short-term results with rapid pain relief and positive effects on patient outcome, implant-related complications, painful pseudarthrosis (non-union of bone), screw loosening, and adjacent segment disease lead to one-third of patients requiring reoperation within 15 years. These complications might be evoked by altered biomechanics with redistribution of loads and subsequently increased stress at the bone-implant interface as well as long fusions leading to relevant, irreversible loss of motion. Therefore, a new treatment modality which reinforces bony spinal segments with ligaments, the so called vertebropexy, was recently developed by Farshad et al. The goal is to achieve targeted stabilization of the spine by inserting ligamentous allografts to counteract instability, without immobilizing the segment. Furthermore, it might provide additional stabilization after decompression surgery and therefore reduce revision surgery rates due to instability in clinically relevant directions as flexion-extension or anterior shear stress. However, to become a broadly accepted surgical alternative to existing surgical techniques for degenerative lumbar spinal disease like dorsal fusion and spinal decompression surgery, the new technique must provide convincing long-term results superior to those of these established procedures which is the primary objective of this randomized controlled trial.

Official Title
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Comparison of a New Ligamentous Fixation Technique Versus Conventional Decompression or Fusion Surgery for Degenerative Lumbar Spinal Disease: A Randomized Controlled Trial

Conditions
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Degeneration, Spinal Stenosis, Fusion of Spine

Intervention / Treatment
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* Procedure: Vertebropexy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Single-level or two-level lumbar surgery 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 Understanding in German language Exclusion Criteria: 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 Surgery on level L5/S1 Inability to understand the study for linguistic or cognitive reasons Anticipated clinical follow-up of less than 6 weeks after inclusion Participation in other clinical trials

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stratification: Indication for decompression (study arm 1) or fusion (study arm 2) Randomization within study arm 1 and study arm 2 between study intervention and control intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Indication for decompression, randomization for decompression<br>microsurgical lumbar laminotomy with partial removal of the medial facet joint by preserving the midline structures; approach: bilateral or ipsilateral with cross-over to the contralateral side | Procedure: Vertebropexy<br>* 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. Stabilization of the spine will be achieved with a biological ligament (for instance semitendinosus donor allograft) which will be pulled through a drilled hole in the spinous process of two adjacent vertebra in a looping technique and tendon ends fixed by an anchor knot after baseball stitches in a standardized fashion. Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia). Passive stability in clinically important directions of motion such as flexion-extension and shear movements will be provided, yet without stiffening other directions of motion.<br>* Other names: ligamentous fixation of the spine;|
| Experimental: Indication for decompression, randomization for vertebropexy<br>decompression (see above) and additional stabilization of the spine with a biological ligament (for instance semitendinosus donor allograft), which will be pulled through a drilled hole in the spinous process of two adjacent vertebra in a looping technique and tendon ends fixed by an anchor knot after baseball stitches in a standardized fashion. Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia). Passive stability in clinically important directions of motion such as flexion-extension and shear movements will be provided, yet without stiffening other directions of motion. | Procedure: Vertebropexy<br>* 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. Stabilization of the spine will be achieved with a biological ligament (for instance semitendinosus donor allograft) which will be pulled through a drilled hole in the spinous process of two adjacent vertebra in a looping technique and tendon ends fixed by an anchor knot after baseball stitches in a standardized fashion. Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia). Passive stability in clinically important directions of motion such as flexion-extension and shear movements will be provided, yet without stiffening other directions of motion.<br>* Other names: ligamentous fixation of the spine;|
| Active Comparator: Indication for fusion, randomization for fusoin<br>decompression and posterolateral instrumented fusion (arthrodesis) with implantation of pedicle screws, titanium alloy rods across the level of listhesis, an intervertebral fusion device and local autograft as well as DBX (demineralized bone matrix) to improve bony fusion | Procedure: Vertebropexy<br>* 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. Stabilization of the spine will be achieved with a biological ligament (for instance semitendinosus donor allograft) which will be pulled through a drilled hole in the spinous process of two adjacent vertebra in a looping technique and tendon ends fixed by an anchor knot after baseball stitches in a standardized fashion. Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia). Passive stability in clinically important directions of motion such as flexion-extension and shear movements will be provided, yet without stiffening other directions of motion.<br>* Other names: ligamentous fixation of the spine;|
| Experimental: Indication for fusion, randomization for vertebropexy<br>decompression (see above) and additional stabilization of the spine with a biological ligament (for instance semitendinosus donor allograft), which will be pulled through a drilled hole in the spinous process of two adjacent vertebra in a looping technique and tendon ends fixed by an anchor knot after baseball stitches in a standardized fashion. Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia). Passive stability in clinically important directions of motion such as flexion-extension and shear movements will be provided, yet without stiffening other directions of motion. | Procedure: Vertebropexy<br>* 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. Stabilization of the spine will be achieved with a biological ligament (for instance semitendinosus donor allograft) which will be pulled through a drilled hole in the spinous process of two adjacent vertebra in a looping technique and tendon ends fixed by an anchor knot after baseball stitches in a standardized fashion. Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia). Passive stability in clinically important directions of motion such as flexion-extension and shear movements will be provided, yet without stiffening other directions of motion.<br>* Other names: ligamentous fixation of the spine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years postoperative | 
| 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 | 2 years postoperative | 
| 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 | 2 years postoperative | 
| 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 | 2 years postoperative | 
| Revision surgery | surgery on same and/or on adjacent levels | 2 years postoperative | 
| Complications | - intraoperative: lesion of nerve root, dural tear, lesion of vessels - postoperative: surgical site infection, wound healing disorder, hematoma, paresis, material loosening (with fusion), material failure (with fusion), pseudarthrosis (with fusion), fracture, allograft tendon rupture (with vertebropexy) - non-surgical: anesthesiological, cardiovascular, pulmonal, thromboembolic, death | 2 years postoperative | 
| Duration of surgery | Duration of intervention in minutes | Perioperative | 
| Length of hospital stay | Duration of hospital stay in days | Perioperative | 
| Intraoperative blood loss | Blood loss intraoperative in ml | Perioperative | 
| Use of analgesia | Intake of analgetics | 2 years postoperative | 
| Use of physical therapy | Necessity to undergo further physical therapy (for instance due to remaining pain or function deficit) | 2 years postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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degenerative lumbar spinal disease, decompression, fusion, vertebropexy, ligamentous fixation