Vertebropexy - Randomized-controlled Trial

Not Applicable

Recruiting

• Conditions: Degeneration; Spinal Stenosis; Fusion of Spine

• Registration Number: NCT06024785
• Lead Sponsor: Balgrist University Hospital

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)

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 Timeline

• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-09-06
• Status Verified: 2024-11
• Study Start: 2025-01-16
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2028-09
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• 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

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
• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Revision surgery	2 years postoperative	surgery on same and/or on adjacent levels
Duration of surgery	Perioperative	Duration of intervention in minutes
Length of hospital stay	Perioperative	Duration of hospital stay in days
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 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
Intraoperative blood loss	Perioperative	Blood loss intraoperative in ml
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
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
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)

Trial Locations

Locations (1)

Balgrist University Hospital; 🇨🇭 Zurich, Switzerland