An MRI based study to know the changes in operative site after 1 year in patients operated for one level lower back operation.
Completed
- Conditions
- TLIF surgery Conventional or MISS
- Registration Number
- CTRI/2017/08/009540
- Lead Sponsor
- Stavya Spine Hospital and Research Institute
- Brief Summary
This study is a randomized, prospective, single centre study analysing the radiological MRI based changes of various muscle groups in the operative site in patients operated for single level lumbar or lumbosacral fusion surgery one year prior to the study initiation time. The primary outcome would be various MRI findings of fibrosis in posterior muscle groups for 2 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Single level Lumbar or lumbosacral fusion operated by conventional approach or MISS technique 2.
- Psychologically, mentally & physically able to fully comply with this protocol including adhering to completing forms & other study procedures.
- Personally signed and dated informed consent document prior to any study related procedures indicating that the patient has been informed of all pertinent aspects of the study.
Exclusion Criteria
- Redo lumbar surgeries 2.
- Lumbar infection 3.
- Multilevel lumbar fusion 4.
- Lumbar laminectomy 5.
- Lumbar discectomy.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method radiological . MRI parameters at work station. 2 years
- Secondary Outcome Measures
Name Time Method radiological . MRI parameters at work station. 2 years
Trial Locations
- Locations (1)
Stavya spine Hospital and Research Institute
🇮🇳Ahmadabad, GUJARAT, India
Stavya spine Hospital and Research Institute🇮🇳Ahmadabad, GUJARAT, IndiaDr D DevanandPrincipal investigator07926565757drdenishpatel@gmail.com