Is Postoperative Bracing Necessary After Spine Surgery for Degenerative Conditions

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Lumbar Spinal Stenosis; Lumbarsacral Orthosis; Transforaminal Lumbar Interbody Fusion
• Intervention / Treatment: Device: Knight-Taylor [chairback] brace

Detailed Description

The inclusion criteria were age older than 18 years and undergoing TLIF for degenerative lumbar disc disease, spinal stenosis, or spondylolisthesis. Those who had 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 were excluded.

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. The attending surgeons and patients were blinded before the 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. 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.

The success of interbody fusion was evaluated by computed tomography (CT) at the 6-month postoperative follow-up using the Brantigan-Steffee-Fraser (BSF) classification6. Radiographic fusion (BSF-3) was defined as bone bridging at least half of the fusion area with at least the density originally achieved at surgery. Radiographic locked pseudarthrosis (BSF-2) was indicated by lucency visible in the middle of the cage with solid bone growing into the cage from each vertebral end plate. Radiographic pseudarthrosis (BSF-1) was indicated by collapse of the construct, loss of disk height, vertebral slip, broken screws, displacement of the cage, significant resorption of the bone graft, or lucency visible around the periphery of the graft or cage.

Perioperative complications, such as wound infection, epidural hematoma, intraoperative dural tear, nerve root damage, and implant dislodgement, were recorded, as were the reoperations and medically related complications within 6 months. The implant-related complications, such as screw loosening, cage migration, or broken screws, detected using plain radiograph at each follow-up and CT scan at the latest follow-up were also recorded. Pedicle screw loosening was defined as a radiolucent zone around the screw on a CT scan at the 6-month follow-up

Statistical analysis was performed using SPSS (version 22.0, IBM Corp., Armonk, NY, USA). Categorical data were compared using chi-square or Fisher's exact test. Continuous data were compared using the independent t-test. The two-tailed significance level was set at p <0.05.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brace group; 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; Knight-Taylor [chairback] brace, is one kind of rigid lumbosacral orthosis. The manufacturer was Rehabilitation and Technical Aid Center, Taipei Veterans General Hospital.
No Intervention: No brace group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
interbody fusion rate	use CT scan to evaluate the bone union condition after interbody fusion of lumbar spine	postoperative 6 months follow-up
complication	any undesirable condition after spinal surgery	postoperative 6 months follow-up
reoperation	any reoperation after primary spinal surgery	postoperative 6 months follow-up

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Study Director: Ming-Chau Chang, M.D, Taipei Veterans General Hospital, Taiwan

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2015
• Primary Completion (Actual): December 25, 2016
• Study Completion (Actual): October 22, 2017

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 6, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Bracing; transforaminal lumbar interbody fusion (TLIF); outcome; fusion rate
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis
• Other Study ID Numbers: 2015-08-006ACF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No