ORthosis vs No Orthosis After Surgically Treated Traumatic Thoracolumbar Fractures

Spine Fracture Clinical Trial

— ORNOT  

Official title:

Orthosis Versus no Orthosis After Dorsally Fixated Traumatic Thoracolumbar Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03097081
• Other study ID #: ORNOT-trial
• Status: Recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: November 2026

Study information

• Verified date: January 2023
• Source: Amsterdam UMC, location VUmc
• Contact: AJ Smits, MD
• Email: aj.smits[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Orthosis
• Posterior Fixation
• Spinal Fractures
• Spine Fracture
• Traumatic Fracture

Intervention

Other:
• No orthosis
The intervention consists of a deviation of the standard protocol; patients do not receive a post-operative orthosis

Device:
• Orthosis
Patients receive post-operative care following the standard protocol and wear an orthosis for 10-12 weeks.

Locations

Country	Name	City	State
Netherlands	VU University medical center	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (NRS)		6 weeks
Secondary	Pain (NRS)		Post-operative, 2 & 12 weeks
Secondary	Quality of life (EQ-5D)		Post-operative, 12 weeks & 6, 12 months
Secondary	Back pain related function (ODI)		Post-operative, 2, 6, 12 weeks & 6, 12 months
Secondary	Kyphosis (Cobb-angle)		Pre-operative, post-operative, 6, 12 weeks & 6, 12 months