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Vertebropexy - Randomized-controlled Trial (VPRCT)

Primary Purpose

Degeneration, Spinal Stenosis, Fusion of Spine

Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Vertebropexy
Sponsored by
Balgrist University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degeneration focused on measuring degenerative lumbar spinal disease, decompression, fusion, vertebropexy, ligamentous fixation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Balgrist University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Indication for decompression, randomization for decompression

Indication for decompression, randomization for vertebropexy

Indication for fusion, randomization for fusoin

Indication for fusion, randomization for vertebropexy

Arm Description

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

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.

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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
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
Revision surgery
surgery on same and/or on adjacent levels
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
Duration of surgery
Duration of intervention in minutes
Length of hospital stay
Duration of hospital stay in days
Intraoperative blood loss
Blood loss intraoperative in ml
Use of analgesia
Intake of analgetics
Use of physical therapy
Necessity to undergo further physical therapy (for instance due to remaining pain or function deficit)

Full Information

First Posted
August 14, 2023
Last Updated
September 22, 2023
Sponsor
Balgrist University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06024785
Brief Title
Vertebropexy - Randomized-controlled Trial
Acronym
VPRCT
Official Title
Comparison of a New Ligamentous Fixation Technique Versus Conventional Decompression or Fusion Surgery for Degenerative Lumbar Spinal Disease: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Balgrist University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degeneration, Spinal Stenosis, Fusion of Spine
Keywords
degenerative lumbar spinal disease, decompression, fusion, vertebropexy, ligamentous fixation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
There is no blinding.
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Indication for decompression, randomization for decompression
Arm Type
Active Comparator
Arm Description
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
Arm Title
Indication for decompression, randomization for vertebropexy
Arm Type
Experimental
Arm Description
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.
Arm Title
Indication for fusion, randomization for fusoin
Arm Type
Active Comparator
Arm Description
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
Arm Title
Indication for fusion, randomization for vertebropexy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Vertebropexy
Other Intervention Name(s)
ligamentous fixation of the spine
Intervention Description
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.
Primary Outcome Measure Information:
Title
ODI (Oswestry Disability Index)
Description
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 Outcome Measure Information:
Title
VAS (Visual Analogue Scale)
Description
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
Title
SSM symptoms/function (Spinal Stenosis Measure)
Description
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
Title
SSM satisfaction (Spinal Stenosis Measure)
Description
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
Title
EQ-5D (European Quality of Life Five Dimension)
Description
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
Title
Revision surgery
Description
surgery on same and/or on adjacent levels
Time Frame
2 years postoperative
Title
Complications
Description
- 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
Time Frame
2 years postoperative
Title
Duration of surgery
Description
Duration of intervention in minutes
Time Frame
Perioperative
Title
Length of hospital stay
Description
Duration of hospital stay in days
Time Frame
Perioperative
Title
Intraoperative blood loss
Description
Blood loss intraoperative in ml
Time Frame
Perioperative
Title
Use of analgesia
Description
Intake of analgetics
Time Frame
2 years postoperative
Title
Use of physical therapy
Description
Necessity to undergo further physical therapy (for instance due to remaining pain or function deficit)
Time Frame
2 years postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mazda Farshad, MD
Phone
+413861111
Email
Mazda.Farshad@balgrist.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina Catanzaro, RN
Phone
+413861111
Email
Sabrina.Catanzaro@balgrist.ch
Facility Information:
Facility Name
Balgrist University Hospital
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mazda Farshad, MD
Phone
+413861111
Email
Mazda.Farshad@balgrist.ch

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators affirm and uphold the principle of the participant's right to privacy and that they shall comply with applicable privacy laws. Especially, anonymity of the participants shall be guaranteed when presenting the data at scientific meetings or publishing them in scientific journals. Individual subject medical information obtained as a result of this study is considered confidential and disclosure to third parties is prohibited. Subject confidentiality will be further ensured by utilising subject identification code numbers to correspond to treatment data in the computer files. For data verification purposes, authorised representatives of the Sponsor (-Investigator), a competent authority (e.g. Swissmedic), or an ethics committee may require direct access to parts of the medical records relevant to the study, including participants' medical history.
Citations:
PubMed Identifier
32474224
Citation
Widmer J, Cornaz F, Scheibler G, Spirig JM, Snedeker JG, Farshad M. Biomechanical contribution of spinal structures to stability of the lumbar spine-novel biomechanical insights. Spine J. 2020 Oct;20(10):1705-1716. doi: 10.1016/j.spinee.2020.05.541. Epub 2020 May 28.
Results Reference
background
PubMed Identifier
36930387
Citation
Farshad M, Tsagkaris C, Widmer J, Fasser MR, Cornaz F, Calek AK. Vertebropexy as a semi-rigid ligamentous alternative to lumbar spinal fusion. Eur Spine J. 2023 May;32(5):1695-1703. doi: 10.1007/s00586-023-07647-y. Epub 2023 Mar 17.
Results Reference
background
PubMed Identifier
37451550
Citation
Calek AK, Widmer J, Fasser MR, Farshad M. Lumbar vertebropexy after unilateral total facetectomy. Spine J. 2023 Jul 13:S1529-9430(23)03259-X. doi: 10.1016/j.spinee.2023.07.005. Online ahead of print.
Results Reference
background
PubMed Identifier
37284900
Citation
Calek AK, Altorfer F, Fasser MR, Widmer J, Farshad M. Interspinous and spinolaminar synthetic vertebropexy of the lumbar spine. Eur Spine J. 2023 Sep;32(9):3183-3191. doi: 10.1007/s00586-023-07798-y. Epub 2023 Jun 7.
Results Reference
background

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Vertebropexy - Randomized-controlled Trial

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