Safety and Efficacy of the ISS Sleeve Augmentation Technique in the Treatment of Thoracolumbar Osteopenic Fractures

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteoporotic Fracture of Vertebra

Intervention / Treatment
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* Device: Augmentation with the ISS Study System
* Other: Augmentation with PMMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: 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: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment with ISS Sleeve<br>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. | Device: Augmentation with the ISS Study System<br>* Augmentation with the ISS Study System<br>|
| Other: Treatment with PMMA<br>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. | Other: Augmentation with PMMA<br>* Augmentation with PMMA (standard)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 3 to 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of x-ray exposure | accumulated duration; from skin incision to skin suture) of patients and medical personnel. | Surgery | 
| Compression rate | Compression rate of the anterior vertebral body height measured in the lateral x-ray | 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 | up to 12 months | 
| Evaluation of the functional outcome with the Oswestry Disability | Oswestry Disability Index (ODI) | baseline, 3 months, 6 months, 12 months | 
| Evaluation of the pain level | Pain Scale as Visual Analogue Scale (VAS) | baseline, 3 months, 6 months, 12 months | 
| Evaluation of the clinical outcome | SF-12 | 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 | at 6 and 12 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone augmentation, spine, pedicle screw, osteoporosis