Comparison of the PEEK cage and an autologous cage in posterior lumbar interbody fusion
| ISRCTN | ISRCTN25558534 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25558534 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/01/2016
- Registration date
- 16/02/2016
- Last edited
- 30/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Public
Department of Orthopaedics, the 175th Hospital of PLA
Southeast Hospital of Xiamen University
269 Zhanghua Road
Zhangzhou
363000
China
Study information
| Study design | Randomized controlled prospective study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Comparison of the PEEK cage and an autologous cage made from the lumbar spinous process and laminae in posterior lumbar interbody fusion |
| Study acronym | PLIF (posterior lumbar interbody fusion) |
| Study objectives | To evaluate the clinical efficacy of PLIF with the PEEK cage and the ACSP in lumbar degenerative disc disease. |
| Ethics approval(s) | Central Ethics Committee of Xiamen University Southeast Hospital, 03/09/2008, ref: 20081102 |
| Health condition(s) or problem(s) studied | 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 | Procedure/Surgery |
| 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 study start date | 30/11/2008 |
| Completion date | 20/10/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 69 |
| Total final enrolment | 69 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/12/2008 |
| Date of final enrolment | 03/12/2010 |
Locations
Countries of recruitment
- China
Study participating centre
Zhangzhou, Fujian
363000
China
Sponsor information
Industry
422 Siming S Rd
Siming
Xiamen
361005
China
"ROR" |
https://ror.org/00mcjh785 |
|---|
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- XMUT
- Location
- China
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planning to publish results of trial soon in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 30/08/2016 | 30/11/2020 | Yes | No |
Editorial Notes
30/11/2020: Publication reference and total final enrolment added.
