Is Postoperative Bracing Necessary After Spine Surgery for Degenerative Conditions

NCT03560401 | Completed

• 1 other identifier: 2015-08-006ACF
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study was started from Oct. 2015. This study aimed to evaluate the outcome of bracing following transforaminal lumbar interbody fusion (TLIF) in patients with degenerative lumbar spine diseases.

Conditions

Degenerative Lumbar Spinal Stenosis; Lumbarsacral Orthosis; Transforaminal Lumbar Interbody Fusion

Keywords

Bracing; transforaminal lumbar interbody fusion (TLIF); outcome; fusion rate

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale and Oswestry Disability Index functional outcome

  Visual Analogue Scale score was patient reported pain scale. The 0 score is no any pain. THe 10 score is the most pain ever. THe more the score the worsen the pain . The Oswestry Disability Index score is the most common used score for lumbar spine disability score. This score had only 10 questions, and all of the questions are related to pain and daily activity. 0 score is no any disability or pain. 100 score is the worst.

  6 months of postoperative follow-up

Secondary Outcomes (3)

• interbody fusion rate

  postoperative 6 months follow-up

• complication

  postoperative 6 months follow-up

• reoperation

  postoperative 6 months follow-up

Study Arms (2)

Brace group

EXPERIMENTAL

After spinal surgery, patients in the brace group were instructed to wear a rigid brace (Knight-Taylor \[chairback\] brace) full-time for 12 weeks, except when bathing or lying in bed.

Device: Knight-Taylor [chairback] brace

No brace group

NO INTERVENTION

After spinal surgery, patients in the no brace group were instructed to wear a soft corset for 2 weeks, after which it was weaned off.

Interventions

Knight-Taylor [chairback] brace DEVICE

Knight-Taylor \[chairback\] brace, is one kind of rigid lumbosacral orthosis. The manufacturer was Rehabilitation and Technical Aid Center, Taipei Veterans General Hospital.

Brace group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients underwent TLIF for degenerative lumbar disc disease, spinal stenosis, or spondylolisthesis

You may not qualify if:

• spinal fracture, spinal infection, spinal tumor, and a history of previous spinal surgery; and those who were lost to follow-up or failed to complete the questionnaires

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Related Publications (2)

• Yee AJ, Yoo JU, Marsolais EB, Carlson G, Poe-Kochert C, Bohlman HH, Emery SE. Use of a postoperative lumbar corset after lumbar spinal arthrodesis for degenerative conditions of the spine. A prospective randomized trial. J Bone Joint Surg Am. 2008 Oct;90(10):2062-8. doi: 10.2106/JBJS.G.01093.

  PMID: 18829902 RESULT

• Soliman HAG, Barchi S, Parent S, Maurais G, Jodoin A, Mac-Thiong JM. Early Impact of Postoperative Bracing on Pain and Quality of Life After Posterior Instrumented Fusion for Lumbar Degenerative Conditions: A Randomized Trial. Spine (Phila Pa 1976). 2018 Feb 1;43(3):155-160. doi: 10.1097/BRS.0000000000002292.

  PMID: 28632643 RESULT

MeSH Terms

Interventions

Braces

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Ming-Chau Chang, M.D

  Taipei Veterans General Hospital, Taiwan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Patients eligible for the study were selected by an independent research assistant. The study was explained, and informed consent was obtained from patients before the surgery. Using a randomization sequence, the patients were assigned to the brace or no brace group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Patients in the brace group were instructed to wear a rigid brace (Knight-Taylor \[chairback\] brace) full-time for 12 weeks, except when bathing or lying in bed. Patients in the no brace group were instructed to wear a soft corset for 2 weeks, after which it was weaned off. All patients started wearing the brace or corset during their first ambulation out of bed following drainage tube removal after the surgery.

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: June 18, 2018
• Study Start: October 20, 2015
• Primary Completion: December 25, 2016
• Study Completion: October 22, 2017
• Last Updated: June 18, 2018

Record last verified: 2018-06

Locations

TW (1)