Evaluation of outcomes after spinal fusion surgery using a titanium-secured cage
Phase 4
- Conditions
- Surgical treatment of Degenerative Disk Diseases (DDD)Musculoskeletal Diseases
- Registration Number
- ISRCTN57950006
- Lead Sponsor
- Spineart SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1. Age 18 years minimum
2. Treated by interbody fusion with SCARLET®AL-T system
3. Non opposition letter signed
Exclusion Criteria
1. Patient lacking capacity to follow postoperative care instructions due to mental state (suffering from dementia and others)
2. Infection
3. Severely damaged bone structures that could prevent stable implantation of the cage
4. Neuromuscular or vascular disorders or illness
5. Inadequate activity
6. Pregnancy
7. Bone tumor in the region of implant
8. Fractures
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate SCARLET®AL-T system performance by assessing interbody fusion by CT scan at 24 months post-operatively.
- Secondary Outcome Measures
Name Time Method