Performance and Safety of Joline® Kyphoplasty Single Balloon Catheter Allevo vs. Quattroplasty Double-Balloon Catheter Stop'n GO With BonOs® Inject Bone Cement

NCT04581707 | Unknown

• 1 other identifier: JO-2020Kypho
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the performance and safety of two balloon kyphoplasty systems (Joline®), the single balloon catheter Allevo and Quattroplasty double balloon catheter Stop'n Go, using BonOs® Inject bone cement for treatment of Vertebral Compression Fractures.

Conditions

Vertebral Compression Fracture

Keywords

Vertebral augmentation; Balloon kyphoplasty systems; Bone cement

Outcome Measures

Primary Outcomes (3)

• Change in vertebral body height

  Change in vertebral body height

  pre-operative, 5 days and 3 months post-operatively

• Change in Visual Analog Scale (VAS) of subjective pain

  The Visual Analog Scale (VAS) is a measure for pain intensity. The score of the sclae ranges from 0 for "no pain" to 10 for "worst imaginable pain". Patients will report their pain at baseline and at 2 dedicated periods to assess change in pain intensity.

  pre-operation, 5 days and 3 months post-operation

• Change in functional disability

  The Oswestry Disability Index (ODI) is used to assess functional disability. The questionnaire consists of 10 items with each item having 6 statements. All scores are summed, then multiplied by two to obtain the index (range from 0 to 100) with higher score indicating greater disability.

  pre-operation, 5 days and 3 months post-operation

Secondary Outcomes (1)

• Safety Outcomes: Occurence of adverse events and complications

  during procedure, 5 days and 3 months post-operation

Study Arms (2)

Kyphoplasty Single Balloon Catheter Allevo

Device: Kyphoplasty Single Balloon Catheter Allevo

Quattroplasty Double Balloon Catheter Stop'n GO

Device: Quattroplasty Double Balloon Catheter Stop'n GO

Interventions

Kyphoplasty Single Balloon Catheter Allevo DEVICE

Vertebral compression fractures treated with Kyphoplasty Single Balloon Catheter Allevo (Joline®) and BonOs® Inject bone cement

Kyphoplasty Single Balloon Catheter Allevo

Quattroplasty Double Balloon Catheter Stop'n GO DEVICE

Vertebral compression fractures treated with Stop'n GO double balloon kyphoplasty system (Joline®) and BonOs® Inject bone cement

Quattroplasty Double Balloon Catheter Stop'n GO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing or patients who have already undergone percutaneous balloon kyphoplasty for treatment of Vertebral Compression Fractures as indicated in the Instructions for use of the investigational devices.

You may qualify if:

• patients aged ≥18 years
• painful VCF(s), of which at least 1 meets the following criteria:
• VCF between T7 and L5
• Fracture age \<3 months
• VCF shows hyperintense signal on STIR or T2 sequence MRI.
• Investigator estimates that target VB(s) is/ are suitable for Quattroplasty double balloon catheter or Kyphoplasty single balloon catheter (e.g. appropriate pedicle diameter, no cortical bone protruding into the spinal canal).
• Patient has an ODI score of 30% or more.
• Patient is willing and able to comply with study requirements.
• Patient signs informed consent form.
• Women who are post-menopausal, surgically sterile or on contraceptives and agree to remain on contraceptives for the duration of their study participation and agree not to become pregnant during the study.

You may not qualify if:

• Segmental kyphosis of target VB of \>30°
• Pre-existing or clinically unstable neurologic deficit
• Any physical exam evidence of myelopathy or radiculopathy
• Not able to walk without assistance prior to fractures
• Any radiographic evidence of pedicle fracture or interspinous-process widening
• Spondylolisthesis \>grade 1 at target VB(s)
• History of spine surgery, including prior vertebral augmentation, during the last year
• Any underlying systemic bone disease other than osteoporosis (e.g. osteomalacia, osteogenesis imperfect, etc.)
• Irreversible coagulopathy and/or taking peri-operatively warfarin (Coumadin) or other anticoagulant
• Pregnancy and nursing
• Pain due to any other condition that requires daily narcotic medication
• Disabling back pain due to causes other than acute fracture
• History of intolerance, or allergic reaction to titanium or acrylic compounds
• Active systemic or local infection at baseline
• Severe cardiopulmonary disease (e.g. stage IV heart failure, severe chronic obstructive pulmonary disease)

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital for Orthopedics Tuebingen

Tübingen, 72076, Germany

RECRUITING

Study Officials

• Lisanne Exner

  University Hopsital for Orthopedics Tuebingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisanne Exner

CONTACT

+4970712986646; Lisanne.Exner@med.uni-tuebingen.de

Christian Walter, MD

CONTACT

+4970712986646; Christian.Walter@med.uni-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical assistant

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: October 9, 2020
• Study Start: March 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)