VPRCT: Vertebropexy - Randomized-controlled Trial

Sponsor

Balgrist University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06024785

Collaborator

(none)

164

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Degeneration Spinal Stenosis Fusion of Spine	Procedure: Vertebropexy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

164 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 interventionStratification: 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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2027

Anticipated Study Completion Date :

Dec 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Indication for decompression, randomization for decompression 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 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. Other Names: ligamentous fixation of the spine
Experimental: Indication for decompression, randomization for vertebropexy 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.	Procedure: Vertebropexy 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. Other Names: ligamentous fixation of the spine
Active Comparator: Indication for fusion, randomization for fusoin 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 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. Other Names: ligamentous fixation of the spine
Experimental: Indication for fusion, randomization for vertebropexy 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.	Procedure: Vertebropexy 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. Other Names: ligamentous fixation of the spine

Outcome Measures

Primary Outcome Measures

ODI (Oswestry Disability Index) [2 years postoperative]
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) [2 years postoperative]
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) [2 years postoperative]
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) [2 years postoperative]
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) [2 years postoperative]
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 [2 years postoperative]
surgery on same and/or on adjacent levels
Complications [2 years postoperative]
- 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 [Perioperative]
Duration of intervention in minutes
Length of hospital stay [Perioperative]
Duration of hospital stay in days
Intraoperative blood loss [Perioperative]
Blood loss intraoperative in ml
Use of analgesia [2 years postoperative]
Intake of analgetics
Use of physical therapy [2 years postoperative]
Necessity to undergo further physical therapy (for instance due to remaining pain or function deficit)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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