Short Segment Fixation in Thoracolumbar Osteoporotic Fracture

Spinal Fractures Clinical Trial

Official title:

Short-segment Decompression and Reconstruction for Thoracolumbar Osteoporotic Fractures With Neurological Deficits: Clinical and Radiological Results of Minimum 2-year Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719340
• Other study ID #: SSF-TLF-103
• Status: Completed
• Phase: N/A
• First received: February 18, 2016
• Last updated: March 21, 2016
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2016
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Although long-segment posterior spinal fixation might provide more rigid fixation, the procedure increases perioperative morbidities in the elderly. The present study reviews the results of short-segment decompression and reconstruction in thoracolumbar fragile fractures.

Description:

This study included 20 elderly patients with osteoporotic thoracolumbar burst fractures and neurological compromise. The participants were followed-up for a period of 40.6 (24-68) months. A visual analog scale (VAS) and the Oswestry Disability Index (ODI) were used to measure back pain and disability. Radiologic assessment and neurological status were also analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria

• osteoporotic burst fracture at a single level of the thoracolumbar region

• dual-energy X-ray absorptiometry and T-score value less than -2.5

Exclusion Criteria

• translational displacement at the fracture site (fracture-dislocation)

• loss of structural integrity within the posterior osteoligamentous complex (such as flexion-distraction ligament disruption)

• spondylolisthesis of the adjacent vertebrae

• malignancy

• chronic steroid administration

• previous spinal surgery

• prior vertebroplasty and infection

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporotic Fractures
• Spinal Fractures

Intervention

Procedure:
• short segment fixation
posterior short-segment decompression and reconstruction (instrumentation on 1 level above and 1 level below the fractured vertebrae with posterolateral fusion)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Oswestry Disability Index (ODI)	Functional outcome after surgery was evaluated using the Oswestry Disability Index (ODI)	at least 2 years	No
Secondary	Frankel's grade system	Frankel's grade system was used for assessment of neurologic function	at least 2 years	No
Secondary	Local kyphosis and vertebral wedge angle were measured as radiologic assessment (units of measure: degree)	Digital radiographs of the vertebral bodies were reviewed using the picture archiving and communication system (PACS).	at least 2 years	No
Secondary	anterior vertebral height	Measurements of the anterior vertebral height (AVH) ratio (% of normal)	at least 2 years	No