Kyphoplasty versus Conservative Therapy with Brace for Vertebral Fractures

Functional Recovery following Early Kyphoplasty versus Conservative Management in Stable Thoracuolumbar Fractures in Parachute Jumpers

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201611172445N3

Enrollment

Registered

2016-12-06

Start date

2012-03-01

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Fracture of thoracic vertebra. Condition 2: Fracture of lumbar vertebra. Fracture of thoracic vertebra Fracture of lumbar vertebra

Interventions

Intervention 1: Percutaneous Baloon Kyphoplasty of the fracture level and injection of 5cc bone cement. Intervention 2: Conservative therapy by applying thoracolumabr orthosis for 3 months.

Treatment - Surgery

Treatment - Other

Percutaneous Baloon Kyphoplasty of the fracture level and injection of 5cc bone cement

Conservative therapy by applying thoracolumabr orthosis for 3 months.

Eligibility

Sex/Gender

Male

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Military parachute jumper; age between 18 and 45 years; acute stable thoracolumbar fractures (T10-L2); stable fractures classifying as A1 and A2 according to AOSpine thoracolumbar spine injury classification system; intact posterior ligamentous complex (PLC); intact neurological exam; acute fracture being confirmed by hypo- and hyper-intense signal change in the vertebral body in T1- and T2-weighted MRI, respectively. Exclusion criteria: Unstable thoracolumbar fractures; ruptured PLC; neurological deficit; being referred later than 30-days of the injury; vertebral angulation of more than 35 degrees; decreased vertebral height of more than 50%; pre-injury neurological deficits; previous thoracolumbar fractures; previous spinal procedures; metabolic bone diseases; history of anaphylactic or drug reactions.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pain intensity. Timepoint: Baseline, 1 month, 3 months, 6 months. Method of measurement: Visual Analogue Scale (VAS).;Disability. Timepoint: Baseline, 1 month, 3 months, 6 months. Method of measurement: Oswestry disability index (ODI).	—

Secondary

Measure	Time frame
Days absence from work. Timepoint: 6 months. Method of measurement: Days.;Duration for starting parachute jumping. Timepoint: 6 months. Method of measurement: Days.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFariborz Ghaffarpasand

Shiraz University of Medical Sciences

ghafarf@sums.ac.ir+98 71 3627 4259

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026