Condition category
Musculoskeletal Diseases
Date applied
06/01/2016
Date assigned
16/02/2016
Last edited
16/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Public

Primary contact

Dr Bin Lin

ORCID ID

Contact details

Department of Orthopaedics
the 175th Hospital of PLA
Southeast Hospital of Xiamen University
269 Zhanghua Road
Zhangzhou
363000
China

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 measures

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

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

Sponsor information

Organisation

Xiamen University

Sponsor details

422 Siming S Rd
Siming
Xiamen
361005
China

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes