Plain English Summary
Background and study aims
Degenerative disc disease in the lumbar spine (or lower back), otherwise known as lumbar degenerative disc disease, refers to a common condition in which a damaged disc causes lower back and leg pain that often requires surgery. For several decades, a treatment called posterior lumbar interbody fusion (PLIF) has been considered the best standard of care. This is a form of spinal fusion surgery which involves adding a bone graft from the iliac crest (a portion of bone from the patients pelvis) to an area of the spine that allows it to grow between two vertebrae to prevent that portion of the spine from moving. It does this by inserting a cage, often made from a synthetic material called PEEK into the disc (intervertebral) space. The researchers doing this study are investigating whether a cage made from the bony projection found at the back of a vertebra (spinous process) and a portion of the vertebral bone called laminae (called a autologous cage using the lumbar spinous process and laminae, or ACSP) will yield similar clinical and radiological results to those obtained using a PEEK cage.
Who can participate?
Adults aged 30-70 suffering from lumbar degenerative disc disease and requiring surgery.
What does the study involve?
Participants undergoing PLIF surgery are randomly allocated to one of two groups. Those in group 1 receive the PEEK cage. Those in group 2 receive the ACSP cage. All participants are then followed up for at least 2 years where the success of their surgery is assessed at regular intervals.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Xiamen University Southeast Hospital (China)
When is the study starting and how long is it expected to run for?
November 2008 to October 2013
Who is funding the study?
Xiamen University of Technology (China)
Who is the main contact?
Dr Bin Lin
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Comparison of the PEEK cage and an autologous cage made from the lumbar spinous process and laminae in posterior lumbar interbody fusion
Acronym
PLIF (posterior lumbar interbody fusion)
Study hypothesis
To evaluate the clinical efficacy of PLIF with the PEEK cage and the ACSP in lumbar degenerative disc disease.
Ethics approval
Central Ethics Committee of Xiamen University Southeast Hospital, 03/09/2008, ref: 20081102
Study design
Randomized controlled prospective study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Lumbar degenerative disc disease.
Intervention
Patients with lumbar degenerative disc disease were randomly assigned to either a PEEK (polyetheretherketone) cage or an autologous cage using the lumbar spinous process and laminae (ACSP). Monosegmental posterior lumbar interbody fusion (PLIF) was performed in all patients. Mean lumbar lordosis, mean disc height, visual analog scale (VAS) scores, functional outcomes, fusion rates and complication rates were recorded and compared. The patients were followed postoperatively for a minimum of 2 years.
Intervention type
Phase
Drug names
Primary outcome measure
Functional outcome was assessed using the Kirkaldy–Willis criteria 3, 6, 12 and 24 months postoperatively and annually thereafter.
Secondary outcome measures
1. Visual Analogue Score (VAS) was obtained for low back pain both pre- and postoperatively at 2-year follow-up
2. Radiological assessment was recorded at at 3, 6, 12 and 24 months postoperatively and annually thereafter
3. Fusion status was evaluated by anteroposterior and lateral flexion and extension radiographs
Overall trial start date
30/11/2008
Overall trial end date
20/10/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients aged between 30-70 years
2. Disc pathology requiring surgical intervention for decompression
3. One intended level of interbody fusion between L3 and S1
4. Radiological evidence of instability, spondylolisthesis and the presence of degenerative stenosis, or symptomatic degenerative disc disease
5. Persistent or recurrent low back or leg pain lasting at least 6 months and resulting in a significant reduction of quality of life
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
69
Participant exclusion criteria
1. Patients need for two or more levels of fusion
2. Active infection
3. Metabolic disease
4. Severe osteoporosis, symptomatic vascular disease
5. Previous spinal surgery other than a lumbar discectomy in L3-L4, L4-L5, or L5-S1
6. Any major psychological problem
7. The combination of degenerative scoliosis and degenerative or isthmic spondylolithesis
8. Morbid obesity
9. Smokers
Recruitment start date
03/12/2008
Recruitment end date
03/12/2010
Locations
Countries of recruitment
China
Trial participating centre
Department of Orthopaedics, the 175th Hospital of PLA, Xiamen University Southeast Hospital
269 Zhanghua Road
Zhangzhou, Fujian
363000
China
Funders
Funder type
University/education
Funder name
Xiamen University of Technology
Alternative name(s)
XMUT
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
China
Results and Publications
Publication and dissemination plan
Planning to publish results of trial soon in a peer reviewed journal.
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list