DegenerationVPRCTNCT06024785
Vertebropexy - Randomized-controlled Trial
A study testing Vertebropexy in people with Degeneration and Spinal Stenosis, run by Balgrist University Hospital at 1 site in Switzerland.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degeneration, Spinal Stenosis, Fusion of Spine
- What is being tested?
- Vertebropexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Jan 2025to 1 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
Mazda Farshad, MD, +413861111, Mazda.Farshad@balgrist.ch
About this study
Official title: Comparison of Ligamentous Fixation Technique (Vertebropexy) Versus Conventional Decompression or Fusion Surgery for Degenerative Lumbar Spinal Disease: A Randomized Controlled Trial
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)
Read the 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.
- Conditions
- Degeneration, Spinal Stenosis, Fusion of Spine
- Being tested
- Vertebropexy
- Keywords
- degenerative lumbar spinal disease, decompression, fusion, vertebropexy, ligamentous fixation
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VertebropexyProcedure or surgery
Also called ligamentous fixation of the spine
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: 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 Receives: 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) Receives: Procedure: Vertebropexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years postoperative
Secondary outcomes (11)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 2 years postoperative
Revision surgery
surgery on same and/or on adjacent levels
Measured: 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
Measured: 2 years postoperative
Duration of surgery
Duration of intervention in minutes
Measured: Perioperative
Length of hospital stay
Duration of hospital stay in days
Measured: Perioperative
Intraoperative blood loss
Blood loss intraoperative in ml
Measured: Perioperative
Use of analgesia
Intake of analgetics
Measured: 2 years postoperative
Use of physical therapy
Necessity to undergo further physical therapy (for instance due to remaining pain or function deficit)
Measured: 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start16 Jan 2025
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024785
- Sponsor's protocol ID
- VPRCT
- Acronym
- VPRCT
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 32474224Farshad 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.
PubMed 36930387Calek 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.
PubMed 37451550Calek 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.
PubMed 37284900
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ligamentous Fixation Technique (Vertebropexy) Versus Conventional Decompression or Fusion Surgery for Degenerative Lumbar Spinal Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06024785
- Acronym / sponsor ID
- VPRCT / VPRCT
- Conditions
- Degeneration, Spinal Stenosis, Fusion of Spine
- Keywords
- degenerative lumbar spinal disease, decompression, fusion, vertebropexy, ligamentous fixation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Indication for decompression, randomization for decompression | Active comparator | Procedure: Vertebropexymicrosurgical (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 |
| Indication for decompression, randomization for vertebropexy | Experimental | Procedure: Vertebropexydecompression (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) |
| Indication for fusion, randomization for fusion | Active comparator | Procedure: Vertebropexydecompression (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 |
| Indication for fusion, randomization for vertebropexy | Experimental | Procedure: Vertebropexydecompression (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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VertebropexyAlso: ligamentous fixation of the spinemicrosurgical (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) | Procedure or surgery | Indication for decompression, randomization for decompression, Indication for decompression, randomization for vertebropexy, Indication for fusion, randomization for fusion, Indication for fusion, randomization for vertebropexy |
Primary outcome
ODI (Oswestry Disability Index)
Time frame: 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
11 secondary outcomes
VAS (Visual Analogue Scale)
Time frame: 2 years postoperative
SSM symptoms/function (Spinal Stenosis Measure)
Time frame: 2 years postoperative
SSM satisfaction (Spinal Stenosis Measure)
Time frame: 2 years postoperative
EQ-5D (European Quality of Life Five Dimension)
Time frame: 2 years postoperative
Revision surgery
Time frame: 2 years postoperative
Complications
Time frame: 2 years postoperative
Duration of surgery
Time frame: Perioperative
Length of hospital stay
Time frame: Perioperative
Intraoperative blood loss
Time frame: Perioperative
Use of analgesia
Time frame: 2 years postoperative
Use of physical therapy
Time frame: 2 years postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 32474224Widmer 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.
- Background: PubMed 36930387Farshad 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.
- Background: PubMed 37451550Calek 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.
- Background: PubMed 37284900Calek 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertebropexy in people with Degeneration and Spinal Stenosis, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mazda Farshad, MD (+413861111, Mazda.Farshad@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ODI (Oswestry Disability Index) (time frame: 2 years postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06024785, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.