Calcium Phosphate Versus PMMA Cement in Thoracolumbar Fractures

NCT04743869 | Unknown

• 1 other identifier: V 2.0
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients at the age of 50 or older presenting with thoracolumbar fractures including segments TH 6-L5 and A3/A4 fractures according to the AO Spine fracture classification after the acute trauma and planned surgery within 3 weeks following trauma will be asked to participate in a randomized trial in which they will receive either Calciumphosphate (CaP) or Polymethylmethacrylate (PMMA) as part of a standardized treatment approach. Regardless of the group patients are randomized to, all participating patients undergo the same surgical procedure except for the preparation and administration of bone cement. The study participation period for each patient is 1 year from the date of the surgery and includes 4 defined time points that include follow-up clinical visits for imaging and progress checks at 6 weeks, 3 months, 6 months and 12 months after surgery. At each follow-up visit, a combination of questionnaires and radiological imaging will be performed to assess general health status, disability level and pain control, as well as objective results of the surgery. The main outcome measure will be the loss of correction rate that will be measured through the bi-segmental COBB angle presented in the CT-scan.

Conditions

SPINAL Fracture

Keywords

Spinal Fractures; Fractures; Polymethyl Methacrylate; PMMA; Bone Cements; Calciumphosphate; Thoracolumbar Fractures; Dorsal Instrumentation; Burst Fractures; Balloon Kyphoplasty

Outcome Measures

Primary Outcomes (2)

• The change in correction rates when using CaP

  The main outcome measure 1 will be the loss of correction rate that will be measured through the bi-segmental COBB angle presented in the CT-scan. The Cobb angle will be measured between the superior end plate of the vertebral body cephalad to the injury and the inferior end plate of the vertebral body caudal to the injury.

  Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively

• The change in correction rates when using PMMA

  The main outcome 2 measure will be the loss of correction rate that will be measured through the bi-segmental COBB angle presented in the CT-scan. The Cobb angle will be measured between the superior end plate of the vertebral body cephalad to the injury and the inferior end plate of the vertebral body caudal to the injury. Measurements will be taken from CT scans.

  Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively

Secondary Outcomes (10)

• The change in vertebral body height when using CaP

  Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively

• The change in vertebral body height when using PMMA

  Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively

• Changes in complication rates when using PMMA

  6 weeks, 3 months, 6 months and 12 months postoperatively

• Changes in complication rates when using CaP

  6 weeks, 3 months, 6 months and 12 months postoperatively

• Change in the disability on the ODI rating scale in patients with PMMA

  Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)

Study Arms (2)

KYPHON® ActivOs™10 Bone Cement with hydroxyapatite

ACTIVE COMPARATOR

As a reference device KYPHON® ActivOs™10 Bone Cement with hydroxyapatite (Medtronic) for treatment of vertebral compression fractures will be used. It is a polymethylmethacrylate (PMMA) bone cement containing hydroxyapatite (HA) for use in the treatment of patients with vertebral compression fractures (VCFs) who are undergoing minimally invasive surgery with KYPHON® Balloon Kyphoplasty. This bone substitute has already been approved and is in use in the patients at the age of 50 or older.

Device: KYPHON ActivOs® Bone Cement with Hydroxyapatite

KyphOs FS™

EXPERIMENTAL

The test device KyphOs FS™ will be used in patients at the age of 50 and older in order to prove its superiority over the currently used PMMA bone cement.

Device: Kyphos FS™ Bone Substitute

Interventions

Kyphos FS™ Bone Substitute DEVICE

Dorsal instrumentation via Longitude II (Medtronic Austria GmbH/Vienna) and balloon kyphoplasty are performed. KyphOs FS™ bone cement will be introduced in the fractured vertebral body.

Also known as: KyphOs FS™ Bone Cement, KyphOs FS™ Medtronic Spine LLC, Minneapolis, MN, USA

KyphOs FS™

KYPHON ActivOs® Bone Cement with Hydroxyapatite DEVICE

Dorsal instrumentation via Longitude II (Medtronic Austria GmbH/Vienna) and balloon kyphoplasty are performed. KYPHON ActivOs® Bone Cement with Hydroxyapatite will be introduced in the fractured vertebral body.

Also known as: KYPHON ActivOs® Bone Cement with Hydroxyapatite, Medtronic Spine LLC, Minneapolis, MN, USA

KYPHON® ActivOs™10 Bone Cement with hydroxyapatite

Eligibility Criteria

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

You may qualify if:

• Written consent of the participant after being informed
• Acute trauma (surgery within three weeks following trauma)
• Thoracolumbar fractures including segments TH 6-L5
• A3/A4 fractures according to the AO Spine fracture classification
• Patient age ≥ 50 years
• Minimum follow up 1 year

You may not qualify if:

• Presence of neurological deficits at the time of surgery
• Pathological fractures (bone metastases)
• Traumatic brain injury
• Ankylosing spondylitis as a comorbidity
• Pregnancy

Sponsors & Collaborators

• Medical University of Graz: lead

MeSH Terms

Conditions

Spinal Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries

Study Officials

• Paul Puchwein, Assist.Prof.

  University Hospital Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gloria Hohenberger, Assist.Prof.

CONTACT

+43 316 385 81721; gloria.hohenberger@medunigraz.at

Marina Bergovec, Dr. Sc.

CONTACT

+43 316 385 87436; marina.bergovec@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients and study nurse will be blinded to treatment allocation; however, surgeons cannot be blinded due to different techniques of bone cement application. A centralized and automated internet-based randomization system will ensure concealed randomization of study participants. Participants will be the unit of randomization. Randomization will be carried out with randomizer.at and will occur prior to the surgical procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: February 1, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share