Fusion rate after using an Intersomatic JULIET®TI cages in lumbar spinal surgery
- Conditions
- arthrodesis of the lumbar spine at one level or at two contiguous levels between L2 and S1 to treat:1. Degenerative pathologies (recurrent hernia, degenerative spondylolisthesis, symptomatic disc disease) 2. Spondylolisthesis by isthmic lysis3. Spine deformity (scoliosis, instability)4. StenosisMusculoskeletal Diseases
- Registration Number
- ISRCTN13793886
- Lead Sponsor
- Spineart (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 52
1. Skeletally mature patients, aged =80 years
2. Treated by interbody fusion with JULIET-TI at 1 or 2 contiguous levels from L2 to S1
3. Symptomatic degenerative disc disease (SDDD), Recurrent herniated disc, Isthmic spondylolisthesis, or Degenerative spondylolisthesis Grade I
4. Non-smokers or recent quitters (for =3 months)
5. Treated non-surgically (for =6 months)
6. No previous surgery at the level to be treated, or previous surgery at the level to be treated without implantation of any material (i.e. operated for herniated disc or decompression)
1. Previous surgery at the level to be treated with implantation of material (i.e. arthrodesis or arthroplasty)
2. Infection at the index level
3. Burst fracture and/or comminuted fracture of the vertebral body and/or vertebral plate
4. Osteoporosis, poor bone quality, or tumour
3. Current smokers
4. Spondylolisthesis Grade II or higher
6. Known metal sensitivity
7. Mental illness, hyperactivity
8. Neuromuscular and/or vascular disorder or illness
9. Pregnancy (current or planned next in the next 6 months)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Interbody fusion status will be qualitatively assessed for all evaluable subjects, using SPECT-CT taken at 6 and 12 months post-surgery
- Secondary Outcome Measures
Name Time Method