Vertebropexy - Randomized-controlled Trial

NCT06024785 | Recruiting DMC

• 1 other identifier: VPRCT
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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 the ligamentous fixation technique (vertebropexy)

Conditions

Degeneration; Spinal Stenosis; Fusion of Spine

Keywords

degenerative lumbar spinal disease; decompression; fusion; vertebropexy; ligamentous fixation

Outcome Measures

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

  2 years postoperative

Secondary Outcomes (11)

• VAS (Visual Analogue Scale)

  2 years postoperative

• SSM symptoms/function (Spinal Stenosis Measure)

  2 years postoperative

• SSM satisfaction (Spinal Stenosis Measure)

  2 years postoperative

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

  2 years postoperative

• Revision surgery

  2 years postoperative

Study Arms (4)

Indication for decompression, randomization for decompression

ACTIVE COMPARATOR

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

Procedure: Vertebropexy

Indication for decompression, randomization for vertebropexy

EXPERIMENTAL

decompression (see above) and 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)

Procedure: Vertebropexy

Indication for fusion, randomization for fusion

ACTIVE COMPARATOR

decompression (see above) 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

Indication for fusion, randomization for vertebropexy

EXPERIMENTAL

decompression (see above) and 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)

Procedure: Vertebropexy

Interventions

Vertebropexy PROCEDURE

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)

Also known as: ligamentous fixation of the spine

Indication for decompression, randomization for decompression; Indication for decompression, randomization for vertebropexy; Indication for fusion, randomization for fusion; Indication for fusion, randomization for vertebropexy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Understanding in German language

You may not qualify if:

• 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
• Inability to understand the study for linguistic or cognitive reasons
• Participation in other clinical trials

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

RECRUITING

Related Publications (4)

• 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.

  PMID: 32474224 BACKGROUND

• 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.

  PMID: 36930387 BACKGROUND

• Calek AK, Widmer J, Fasser MR, Farshad M. Lumbar vertebropexy after unilateral total facetectomy. Spine J. 2023 Nov;23(11):1730-1737. doi: 10.1016/j.spinee.2023.07.005. Epub 2023 Jul 13.

  PMID: 37451550 BACKGROUND

• 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.

  PMID: 37284900 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Mazda Farshad, MD

CONTACT

+413861111; Mazda.Farshad@balgrist.ch

Sabrina Catanzaro, RN

CONTACT

+413861111; Sabrina.Catanzaro@balgrist.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * 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

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: September 6, 2023
• Study Start: January 16, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)