ORthosis vs No Orthosis After Surgically Treated Traumatic Thoracolumbar Fractures (ORNOT)

January 21, 2023 updated by: AJ Smits, Amsterdam UMC, location VUmc

Orthosis Versus no Orthosis After Dorsally Fixated Traumatic Thoracolumbar Fractures

Rationale: There is no evidence in the current literature regarding the additional value of an orthosis after surgically treated thoracolumbar spine fractures.

Objective: To assess whether an orthosis provides additional pain relief compared to no orthosis after posteriorly fixated thoracolumbar spine fractures. Primary outcome is difference in pain at six weeks post-operatively. Secondary objectives are pain at other moments, pain medication used, pain related disability, quality of life, long-term kyphosis, possible complications, hospital stay, return to work and subjective feeling on benefit or disadvantage from the orthosis.

Study design: Randomized controlled intervention study, non-inferiority trial.

Study population: Dutch speaking patients presented at the VU university medical centre, 18 - 65 years old with a traumatic thoracolumbar spine fracture from Th7 - L4 surgically treated by posterior fixation.

Intervention: One group receives standard care and wears an orthosis after surgery for 12 weeks, to use when in vertical position. The intervention group does not wear an orthosis after surgery.

Main study parameters/endpoints: Main study outcome is the difference in pain noted on the NRS-score at six weeks, ≥ 2 (SD 2,5) change corresponds with a clinically significant change in pain score.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The current guideline for postoperative care regarding dorsal stabilization of spine fractures recommends the use of a post-operative orthosis. While patients generally receive an orthosis for 12 weeks, individual surgeon's believes sometimes gives reason to deviate from this guideline. This is founded by literature that increasingly questions the use of orthoses in the conservative treatment of spine fractures. With the fracture operatively stabilized, the orthosis mainly provides support of gesture and thereby potentially results in pain relief and confidence for patients. On the other hand some patients have a hard time weaning from the orthosis or report discomfort due to the device and prefer not to use it. With subjects being randomized between the use of an orthosis or no orthosis there is no additional risk. This is in part because it is hypothesized that there is no difference in postoperative pain and there might be a lower risk of complications related to the orthosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1018HV
        • Recruiting
        • VU University Medical Center
        • Contact:
        • Principal Investigator:
          • FW Bloemers, MD, PhD
        • Principal Investigator:
          • J Deunk, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 - 65 years
  • Traumatic thoracolumbar spine fracture from thoracic 7 - lumbar 4
  • AO fracture types A-C
  • Undergoing surgical dorsal fixation for fracture

Exclusion Criteria:

  • Inadequate knowledge of Dutch language or to fill in questionnaire
  • Complete or partial spinal cord injury (ASIA A to D)
  • (Additional) anterior surgical stabilization
  • Thoracolumbar fracture of other aetiology than traumatic, e.g. pathologic, infectious
  • Not able to walk before fracturing vertebra
  • Unable to come to the outpatient clinic (e.g. residing outside the Netherlands)
  • Injury Severity Score (ISS) ≥ 16
  • Brain injury with Abbreviated Injury Score (AIS) ≥ 4
  • Solitary Lumbar 5 fracture

  • Inability to wear an orthosis, most probable reasons:

    • BMI > 35

    • Thoraco-abdominal wounds (through trauma or secondary from surgery) on places at which the orthosis contacts the body so aggravation of pain or chances of infection increase significantly.

      12 of 27

    • Pre-existing spine deformities (scoliosis or very severe kyphosis/lordosis) which impair the use of the orthosis or aggravate pain.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No orthosis
The intervention consists of a deviation of the standard protocol; patients post-operatively do not receive an orthosis.
Other: No orthosis
The intervention consists of a deviation of the standard protocol; patients do not receive a post-operative orthosis
Active Comparator: Orthosis
As in correspondence with local and international guidelines, patients receive an orthosis as standard post-operative care. This is considered the control group.
Device: Orthosis
Patients receive post-operative care following the standard protocol and wear an orthosis for 10-12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain (NRS)
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain (NRS)
Time Frame: Post-operative, 2 & 12 weeks
Post-operative, 2 & 12 weeks
Quality of life (EQ-5D)
Time Frame: Post-operative, 12 weeks & 6, 12 months
Post-operative, 12 weeks & 6, 12 months
Back pain related function (ODI)
Time Frame: Post-operative, 2, 6, 12 weeks & 6, 12 months
Post-operative, 2, 6, 12 weeks & 6, 12 months
Kyphosis (Cobb-angle)
Time Frame: Pre-operative, post-operative, 6, 12 weeks & 6, 12 months
Pre-operative, post-operative, 6, 12 weeks & 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

November 1, 2026

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

March 24, 2017

First Posted (Actual)

March 31, 2017

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 21, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORNOT-trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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