Calcium Phosphate Versus PMMA Cement in Thoracolumbar Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-28

Study Completion Date

2024-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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SPINAL Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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KYPHON® ActivOs™10 Bone Cement with hydroxyapatite

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.

Group Type ACTIVE_COMPARATOR

KYPHON ActivOs® Bone Cement with Hydroxyapatite

Intervention Type 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.

KyphOs FS™

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.

Group Type EXPERIMENTAL

Kyphos FS™ Bone Substitute

Intervention Type 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.

Interventions

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Kyphos FS™ Bone Substitute

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.

Intervention Type DEVICE

KYPHON ActivOs® Bone Cement with Hydroxyapatite

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.

Intervention Type DEVICE

Other Intervention Names

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KyphOs FS™ Bone Cement KyphOs FS™ Medtronic Spine LLC, Minneapolis, MN, USA KYPHON ActivOs® Bone Cement with Hydroxyapatite, Medtronic Spine LLC, Minneapolis, MN, USA

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No