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

NCT04495439 | Terminated DMC

• 1 other identifier: ISSCLIN-01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Keywords

bone augmentation; spine; pedicle screw; osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time of x-ray exposure

  Surgery

• Compression rate

  post-operatively before discharge (day 3 (± 1 day)) compared to 3, 6 and 12 months postoperatively

• Screw loosening

  up to 12 months

• Evaluation of the functional outcome with the Oswestry Disability

  baseline, 3 months, 6 months, 12 months

• Evaluation of the pain level

  baseline, 3 months, 6 months, 12 months

Study Arms (2)

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.

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.

Other: Augmentation with PMMA

Interventions

Augmentation with the ISS Study System DEVICE

Augmentation with the ISS Study System

Treatment with ISS Sleeve

Augmentation with PMMA OTHER

Augmentation with PMMA (standard)

Treatment with PMMA

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nexilis AG: lead

Study Sites (1)

Dept. of Orthopaedics and Traumatology, Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Polymethyl Methacrylate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Methylmethacrylates; Polymethacrylic Acids; Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Acrylic Resins; Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Richard Lindtner, M.D

  Department of Trauma Surgery, Medical University of Innsbruck, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 31, 2020
• Study Start: September 11, 2019
• Primary Completion: September 14, 2020
• Study Completion: October 25, 2022
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)