Calcium Phosphate Versus PMMA Cement in Thoracolumbar Fractures (CaPvsPMMA)

Medical University of Graz

Status: Unknown

Conditions: SPINAL Fracture

Treatments: Device: KYPHON ActivOs® Bone Cement with Hydroxyapatite; Device: Kyphos FS™ Bone Substitute

Study type: Interventional

Funder types: Other

Identifiers

NCT04743869

V 2.0

Details and patient eligibility

About

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.

Enrollment: 85 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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85 participants in 2 patient groups

KYPHON® ActivOs™10 Bone Cement with hydroxyapatite

Active Comparator group

Description:

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.

Treatment:

Device: KYPHON ActivOs® Bone Cement with Hydroxyapatite

KyphOs FS™

Experimental group

Description:

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.

Treatment:

Device: Kyphos FS™ Bone Substitute