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Is Postoperative Bracing Necessary After Spine Surgery for Degenerative Conditions

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Knight-Taylor [chairback] brace
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Lumbar Spinal Stenosis focused on measuring Bracing; transforaminal lumbar interbody fusion (TLIF); outcome; fusion rate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brace group

No brace group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

interbody fusion rate
use CT scan to evaluate the bone union condition after interbody fusion of lumbar spine
complication
any undesirable condition after spinal surgery
reoperation
any reoperation after primary spinal surgery

Full Information

First Posted
December 21, 2017
Last Updated
June 6, 2018
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03560401
Brief Title
Is Postoperative Bracing Necessary After Spine Surgery for Degenerative Conditions
Official Title
Is Postoperative Bracing Necessary After Spine Surgery for Degenerative Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 20, 2015 (Actual)
Primary Completion Date
December 25, 2016 (Actual)
Study Completion Date
October 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Lumbar Spinal Stenosis, Lumbarsacral Orthosis, Transforaminal Lumbar Interbody Fusion
Keywords
Bracing; transforaminal lumbar interbody fusion (TLIF); outcome; fusion rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brace group
Arm Type
Experimental
Arm Description
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.
Arm Title
No brace group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Knight-Taylor [chairback] brace
Intervention Description
Knight-Taylor [chairback] brace, is one kind of rigid lumbosacral orthosis. The manufacturer was Rehabilitation and Technical Aid Center, Taipei Veterans General Hospital.
Primary Outcome Measure Information:
Title
Visual Analogue Scale and Oswestry Disability Index functional outcome
Description
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.
Time Frame
6 months of postoperative follow-up
Secondary Outcome Measure Information:
Title
interbody fusion rate
Description
use CT scan to evaluate the bone union condition after interbody fusion of lumbar spine
Time Frame
postoperative 6 months follow-up
Title
complication
Description
any undesirable condition after spinal surgery
Time Frame
postoperative 6 months follow-up
Title
reoperation
Description
any reoperation after primary spinal surgery
Time Frame
postoperative 6 months follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Chau Chang, M.D
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18829902
Citation
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.
Results Reference
result
PubMed Identifier
28632643
Citation
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.
Results Reference
result

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Is Postoperative Bracing Necessary After Spine Surgery for Degenerative Conditions

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