Osteoporotic Fracture of VertebraNCT04495439
Safety and Efficacy of the ISS Sleeve Augmentation Technique in the Treatment of Thoracolumbar Osteopenic Fractures
A study testing Augmentation with the ISS Study System and Augmentation with PMMA in people with Osteoporotic Fracture of Vertebra, run by Nexilis AG at 1 site in Austria.
Trial summary
Implant anchorage is difficult in patient with osteoporotic bone. To improve the implant bone interface, the ISS stabilization system has been developed. The goal of the study is to investigate the efficacy the ISS augmentation compared to the standard PMMA augmentation of pedicle screws in the treatment of patients… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteoporotic Fracture of Vertebra
- What is being tested?
- Augmentation with the ISS Study System and Augmentation with PMMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteAustria
- Study dates
- 11 Sep 2019to 25 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient
- Age ≥ 50 and ≤ 85, male and female patients
- Subject is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent.
- Psychosocially, mentally and physically able to fully comply with the protocol requirements for the duration of the study including adhering to scheduled visits, treatment plan, completing forms and other study procedures.
- Fracture
- Fractures between the 10th thoracic and 4th lumbar vertebra, both included
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- Bone mineral density equal or above the threshold of 60 mgHA/ccm (central assessment of the screening qCT scan).
- Fractures with the indication and possibility for augmented bi-segmental dorsal pedicle screw and rod stabilization including kyphoplasty in the broken vertebra
- All fractures where pedicle screws can be used
Who cannot join
- Patient
- Substance use disorders (incl. tobacco abuse >20 cigarettes/day) and alcohol abuse disorders within the last 2 years before randomization.
- BMI > 35
- Permanent or progressive neurologic deficits (incl. upper motor neuron disease and myelopathy)
- Known Creutzfeldt Jacob Disease
- Systemic infections:
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- Known infection with human immunodeficiency virus (HIV) or, hepatitis B or C requiring treatment
- Any active infection requiring the use of parenteral anti-microbial agents or that is > grade 2 Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
- Rheumatoid arthritis or known disorders of bone metabolism (excl. osteopenia/osteoporosis, Vitamin D deficiency)
- Radiation therapy of the spine in medical history
- Contraindications to pedicle screw and rod stabilization
- Breast feeding, pregnancy or child-bearing potential (female patients of childbearing potential and male patients with a partner of child bearing potential must agree to use a highly effective contraceptive method).
- A compromised immune system or a therapy with systemic corticosteroids or immunosuppressants
- Active malignancy or history of malignancy (excl. Basalioma as a semi-malignant tumor) <2 years ago from time of randomization
- Known allergy to any component of the investigational device
- History of severe allergy, anaphylactic reactions and hypersensitivity reactions experienced in previous surgical interventions.
- Other concurrent severe and/or uncontrolled medical conditions (e.g. insufficiently treated diabetes (HbA1c > 8 %), active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
- Participation in other clinical investigations for drugs or devices
- Fracture
- Fracture age > 3 months
- Major surgery to the spine planned for at least 12 months following enrolment
- Any treatment of the fracture other than that specified in the inclusion criteria (e.g. index screws in the fractured vertebra, vertebroplasty, additional ventral stabilization)
- Severe spinal deformations or fusion at the target vertebral or adjacent segments
- Previous operations at the spine in the target or adjacent vertebrae
- Infections or inflammatory processes at vertebral bodies
Trial locations and contacts
1 site in 1 country.
Austria1 site
Dept. of Orthopaedics and Traumatology, Medical University of Innsbruck
Innsbruck, Tyrol, 6020
About this study
Official title: Safety and Efficacy of the New ISS Sleeve Augmentation Technique in the Treatment of Osteoporotic/Osteopenic Vertebral Fractures in the Thoraco-lumbar Spine: A Pilot Study and Subsequent Comparison to the Standard PMMA-Screw Augmentation
Implant anchorage is difficult in patient with osteoporotic bone. To improve the implant bone interface, the ISS stabilization system has been developed. The goal of the study is to investigate the efficacy the ISS augmentation compared to the standard PMMA augmentation of pedicle screws in the treatment of patients suffering from osteoporotic/osteopenic thoracolumbar fracture.
The study has two phases, a pilot phase followed by a pivotal phase. The data will be used to measure clinical and radiological performance and usability of both systems.
- Conditions
- Osteoporotic Fracture of Vertebra
- Being tested
- Augmentation with the ISS Study System, Augmentation with PMMA
- Keywords
- bone augmentation, spine, pedicle screw, osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmentation with the ISS Study SystemDevice
Augmentation with the ISS Study System
Augmentation with PMMAOther
Augmentation with PMMA (standard)
| Study group | Role | What they receive |
|---|---|---|
| Treatment with ISS Sleeve | Other | The biocompatible, resorbable ISS sleeve is used for augmentation to enhance screw anchorage. It is melted into the trabecular bone structure of the osteoporotic vertebra using ultrasound. A standard pedicle screw is inserted into the sleeve. Receives: Device: Augmentation with the ISS Study System |
| Treatment with PMMA | Other | The bone cement Polymethylmethacrylat (PMMA) that is injected into the osteoporotic vertebra.PMMA augmentation of pedicle screws is done using standard cannulated and perforated pedicle screws. The cancellous bone surrounding the screw is enhanced with PMMA bone cement to increase screw anchorage. Receives: Other: Augmentation with PMMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the bi-segmental kyphosis angle (Correction Loss)
The evaluation will be done from a comparison of plain x-rays taken post-operatively before discharge (day 3 (± 1 day)) and 6 months post operatively both in upright position. The correction loss of the bi-segmental kyphosis angle will be compared in the ISS Sleeve screw augmentation group and the standard PMMA screw augmentation group.
Measured: Day 3 to 6 Months
Secondary outcomes (7)
Time of x-ray exposure
accumulated duration; from skin incision to skin suture) of patients and medical personnel.
Measured: Surgery
Compression rate
Compression rate of the anterior vertebral body height measured in the lateral x-ray
Measured: post-operatively before discharge (day 3 (± 1 day)) compared to 3, 6 and 12 months postoperatively
Screw loosening
Screw loosening measured following the method of Aghayev et al. The angle between the axes of the pedicle screws and the cranial endplate are measured
Measured: up to 12 months
Evaluation of the functional outcome with the Oswestry Disability
Oswestry Disability Index (ODI)
Measured: baseline, 3 months, 6 months, 12 months
Evaluation of the pain level
Pain Scale as Visual Analogue Scale (VAS)
Measured: baseline, 3 months, 6 months, 12 months
Evaluation of the clinical outcome
SF-12
Measured: baseline, 3 months, 6 months, 12 months
Treatment success
composite endpoint including the correction loss of the bi-segmental kyphosis angle, the ODI and the occurrence of any device-related serious adverse events
Measured: at 6 and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start11 Sep 2019
- Primary completion14 Sep 2020
- Study completion25 Oct 2022
Why it stopped: Change in company strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic Fracture of VertebraStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nexilis AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Lindtner, M.D, Principal investigator, Department of Trauma Surgery, Medical University of Innsbruck, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495439
- Sponsor's protocol ID
- ISSCLIN-01
- Status last verified
- Feb 2024
- First submitted
- 22 Jul 2020
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the New ISS Sleeve Augmentation Technique in the Treatment of Osteoporotic/Osteopenic Vertebral Fractures in the Thoraco-lumbar Spine: A Pilot Study and Subsequent Comparison to the Standard PMMA-Screw Augmentation
- ClinicalTrials.gov ID
- NCT04495439
- Acronym / sponsor ID
- ISSCLIN-01
- Conditions
- Osteoporotic Fracture of Vertebra
- Keywords
- bone augmentation, spine, pedicle screw, osteoporosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in company strategy
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Nexilis AGIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 31 Jul 2020 (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.
Implant anchorage is difficult in patient with osteoporotic bone. To improve the implant bone interface, the ISS stabilization system has been developed. The goal of the study is to investigate the efficacy the ISS augmentation compared to the standard PMMA augmentation of pedicle screws in the treatment of patients suffering from osteoporotic/osteopenic thoracolumbar fracture.
The study has two phases, a pilot phase followed by a pivotal phase. The data will be used to measure clinical and radiological performance and usability of both systems.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with ISS Sleeve | Other | Device: Augmentation with the ISS Study SystemThe biocompatible, resorbable ISS sleeve is used for augmentation to enhance screw anchorage. It is melted into the trabecular bone structure of the osteoporotic vertebra using ultrasound. A standard pedicle screw is inserted into the sleeve. |
| Treatment with PMMA | Other | Other: Augmentation with PMMAThe bone cement Polymethylmethacrylat (PMMA) that is injected into the osteoporotic vertebra.PMMA augmentation of pedicle screws is done using standard cannulated and perforated pedicle screws. The cancellous bone surrounding the screw is enhanced with PMMA bone cement to increase screw anchorage. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient
- Age ≥ 50 and ≤ 85, male and female patients
- Subject is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent.
- Psychosocially, mentally and physically able to fully comply with the protocol requirements for the duration of the study including adhering to scheduled visits, treatment plan, completing forms and other study procedures.
- Fracture
Key exclusion criteria (25 listed)
- Patient
- Substance use disorders (incl. tobacco abuse >20 cigarettes/day) and alcohol abuse disorders within the last 2 years before randomization.
- BMI > 35
- Permanent or progressive neurologic deficits (incl. upper motor neuron disease and myelopathy)
- Known Creutzfeldt Jacob Disease
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 |
|---|---|---|
| Augmentation with the ISS Study SystemAugmentation with the ISS Study System | Device | Treatment with ISS Sleeve |
| Augmentation with PMMAAugmentation with PMMA (standard) | Other | Treatment with PMMA |
Primary outcome
Change of the bi-segmental kyphosis angle (Correction Loss)
Time frame: Day 3 to 6 Months
The evaluation will be done from a comparison of plain x-rays taken post-operatively before discharge (day 3 (± 1 day)) and 6 months post operatively both in upright position. The correction loss of the bi-segmental kyphosis angle will be compared in the ISS Sleeve screw augmentation group and the standard PMMA screw augmentation group.
7 secondary outcomes
Time of x-ray exposure
Time frame: Surgery
Compression rate
Time frame: post-operatively before discharge (day 3 (± 1 day)) compared to 3, 6 and 12 months postoperatively
Screw loosening
Time frame: up to 12 months
Evaluation of the functional outcome with the Oswestry Disability
Time frame: baseline, 3 months, 6 months, 12 months
Evaluation of the pain level
Time frame: baseline, 3 months, 6 months, 12 months
Evaluation of the clinical outcome
Time frame: baseline, 3 months, 6 months, 12 months
Treatment success
Time frame: at 6 and 12 months postoperatively
Results and safety
The study was stopped early (reason given: Change in company strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Richard Lindtner, M.D principal investigator
Department of Trauma Surgery, Medical University of Innsbruck, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmentation with the ISS Study System and Augmentation with PMMA in people with Osteoporotic Fracture of Vertebra, run by Nexilis AG at 1 site in Austria.
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 9 inclusion and 25 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: stopped early, as of the sponsor's last update on 9 Feb 2024. 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 Austria. 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?
The study was stopped early (reason given: Change in company strategy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the bi-segmental kyphosis angle (Correction Loss) (time frame: Day 3 to 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2024.