Comparison of the PEEK cage and an autologous cage in posterior lumbar interbody fusio
- Conditions
- umbar degenerative disc disease.Musculoskeletal Diseases
- Registration Number
- ISRCTN25558534
- Lead Sponsor
- Xiamen University
- Brief Summary
2016 results in https://pubmed.ncbi.nlm.nih.gov/27577978/ (added 30/11/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 69
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional outcome was assessed using the Kirkaldy–Willis criteria 3, 6, 12 and 24 months postoperatively and annually thereafter.
- Secondary Outcome Measures
Name Time Method <br> 1. Visual Analogue Score (VAS) was obtained for low back pain both pre- and postoperatively at 2-year follow-up<br> 2. Radiological assessment was recorded at at 3, 6, 12 and 24 months postoperatively and annually thereafter<br> 3. Fusion status was evaluated by anteroposterior and lateral flexion and extension radiographs<br>