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

Osteoporotic Fracture of Vertebra Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04495439
• Other study ID #: ISSCLIN-01
• Status: Terminated
• Phase: N/A
• Start date: September 11, 2019
• Est. completion date: October 25, 2022

Study information

• Verified date: February 2024
• Source: Nexilis AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 25, 2022
• Est. primary completion date: September 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

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

18. 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)

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

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporotic Fracture of Vertebra
• Osteoporotic Fractures
• Spinal Fractures

Intervention

Device:
• Augmentation with the ISS Study System
Augmentation with the ISS Study System

Other:
• Augmentation with PMMA
Augmentation with PMMA (standard)

Locations

Country	Name	City	State
Austria	Dept. of Orthopaedics and Traumatology, Medical University of Innsbruck	Innsbruck	Tirol

Sponsors (1)

Lead Sponsor	Collaborator
Nexilis AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time of x-ray exposure	accumulated duration; from skin incision to skin suture) of patients and medical personnel.	Surgery
Secondary	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
Secondary	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
Secondary	Evaluation of the functional outcome with the Oswestry Disability	Oswestry Disability Index (ODI)	baseline, 3 months, 6 months, 12 months
Secondary	Evaluation of the pain level	Pain Scale as Visual Analogue Scale (VAS)	baseline, 3 months, 6 months, 12 months
Secondary	Evaluation of the clinical outcome	SF-12	baseline, 3 months, 6 months, 12 months
Secondary	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