An interventional study of Vertebropexy in Degeneration, Spinal Stenosis and Fusion of Spine, sponsored by Balgrist University Hospital. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Balgrist University Hospital · Not applicable, Interventional, and Treatment
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)
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.
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's planned enrollment of 164 is above the median of 80 across 281 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Balgrist University Hospital is the lead sponsor of 81 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion criteria:
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
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
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
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
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
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
Time frame: 2 years postoperative
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 years postoperative
Revision surgery
surgery on same and/or on adjacent levels
Time frame: 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
Time frame: 2 years postoperative
Duration of surgery
Duration of intervention in minutes
Time frame: Perioperative
Length of hospital stay
Duration of hospital stay in days
Time frame: Perioperative
Intraoperative blood loss
Blood loss intraoperative in ml
Time frame: Perioperative
Use of analgesia
Intake of analgetics
Time frame: 2 years postoperative
Use of physical therapy
Necessity to undergo further physical therapy (for instance due to remaining pain or function deficit)
Time frame: 2 years postoperative
Plan to share: No — 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.
Started Jan 2025 (actual). Primary completion is estimated for Sep 2030, 67 months after the start.
Of 105 non-industry interventional studies with no phase under Spinal Stenosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 67 months is above that.
Counting every sponsor, half of 123 studies reached it within 30 months; a quarter within 12 and three quarters within 50.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 28, 2026: primary completion Sep 2028 → Sep 2030 and completion Dec 2028 → Dec 2030.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Balgrist University Hospital