Status:
UNKNOWN
Evaluation of Treatment Effect of Minimally Invasive Spinal Fusion Surgery
Lead Sponsor:
Chi Mei Medical Hospital
Conditions:
Spinal Fusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Participants with lumbar spondylosis, degenerative disc disease, spondylolisthesis, scoliosis, or trauma undergoing elective Transforaminal lumbar interbody fusion (TLIF) were recruited. The follow-up...
Detailed Description
After receiving prophylactic antibiotics according to the local hospital protocol, the patients were generally anesthetized in a prone position. Paramedian or midline posterior sections were conducted...
Eligibility Criteria
Inclusion
- spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. Patients should have had six months of non-operative treatment prior to treatment with an intervertebral body fusion device.
Exclusion
- Patients unsuitable for anesthesia
- Active systemic infection, infection or suspected latent infection localized to the site of the proposed implantation
- Excessive local inflammation
- Rapid joint disease, bone absorption, osteopenia
- Severe osteoporosis or osteopenia
- Morbid obesity
- Pregnancy
- Open wounds
- Patients have demonstrated allergy or foreign body sensitivity to any of the implant materials
- Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cell count (WBC), or marked left shift in the WBC differential count
- Patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant during bony healing and may be at a higher risk of implant failure
- Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance
- Any condition not described in the indications for use
Key Trial Info
Start Date :
March 25 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 26 2023
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT05190055
Start Date
March 25 2015
End Date
February 26 2023
Last Update
July 19 2022
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