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

NCT ID: NCT04495439

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-11
• Study Completion Date: 2022-10-25

Brief 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment with ISS Sleeve

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.

Group Type: OTHER

Augmentation with the ISS Study System

Intervention Type: DEVICE

Augmentation with the ISS Study System

Treatment with PMMA

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.

Group Type: OTHER

Augmentation with PMMA

Intervention Type: OTHER

Augmentation with PMMA (standard)

Interventions

Augmentation with the ISS Study System

Augmentation with the ISS Study System

Intervention Type: DEVICE

Augmentation with PMMA

Augmentation with PMMA (standard)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patient

1. Age ≥ 50 and ≤ 85, male and female patients

2. Subject is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent.

3. 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

4. Fractures between the 10th thoracic and 4th lumbar vertebra, both included

5. Bone mineral density equal or above the threshold of 60 mgHA/ccm (central assessment of the screening qCT scan).

6. Fractures with the indication and possibility for augmented bi-segmental dorsal pedicle screw and rod stabilization including kyphoplasty in the broken vertebra

7. All fractures where pedicle screws can be used

19. Severe spinal deformations or fusion at the target vertebral or adjacent segments

20. Previous operations at the spine in the target or adjacent vertebrae

21. Infections or inflammatory processes at vertebral bodies

Exclusion Criteria

Patient

1. Substance use disorders (incl. tobacco abuse >20 cigarettes/day) and alcohol abuse disorders within the last 2 years before randomization.

2. BMI > 35

3. Permanent or progressive neurologic deficits (incl. upper motor neuron disease and myelopathy)

4. Known Creutzfeldt Jacob Disease

5. 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

6. Rheumatoid arthritis or known disorders of bone metabolism (excl. osteopenia/osteoporosis, Vitamin D deficiency)

7. Radiation therapy of the spine in medical history

8. Contraindications to pedicle screw and rod stabilization

9. 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).

10. A compromised immune system or a therapy with systemic corticosteroids or immunosuppressants

11. Active malignancy or history of malignancy (excl. Basalioma as a semi-malignant tumor) <2 years ago from time of randomization

12. Known allergy to any component of the investigational device

13. History of severe allergy, anaphylactic reactions and hypersensitivity reactions experienced in previous surgical interventions.

14. 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

15. Participation in other clinical investigations for drugs or devices

Fracture

16. Fracture age > 3 months

17. Major surgery to the spine planned for at least 12 months following enrolment

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nexilis AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Lindtner, M.D

Role: PRINCIPAL_INVESTIGATOR

Department of Trauma Surgery, Medical University of Innsbruck, Austria

Locations

Dept. of Orthopaedics and Traumatology, Medical University of Innsbruck

Innsbruck, Tyrol, Austria

Countries

Austria

Other Identifiers

ISSCLIN-01

Identifier Type: -

Identifier Source: org_study_id