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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04778943
Other study ID # TDGKJZ
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 28, 2021
Est. completion date March 29, 2021

Study information

Verified date February 2021
Source Tang-Du Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators will retrospectively study lumbar spinal stenosis patients who underwent OLIF or MIS-TLIF with percutaneous pedicle screw fixation between January 2016 and December 2019.The investigators will measure estimated blood loss, operative time, hospital stay, cost, reoperation, and complication incidence, visual analogue scale (VAS), Oswestry Disability Index (ODI), Japanese Orthopaedic Association (JOA), and Short Form-36 (SF-36) scores, discal and foraminal height, lumbar lordotic angle, and fusion status.The investigators will conduct to evaluate postoperative improvements, complications, and reoperation rates between patients with lumbar spinal stenosis (LSS) undergoing oblique lateral interbody fusion (OLIF) or minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 130
Est. completion date March 29, 2021
Est. primary completion date March 25, 2021
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - LSS due to neurogenic claudication; Central stenosis or lateral stenosis who need surgery; Single-level, low-grade (Meyerding grade 1 or 2) isthmic spondylolisthesis or degenerative spondylolisthesis; and imaging findings consistent with the symptoms of LSS. Exclusion Criteria: - trauma, active infection, malignant tumors, spinal deformity, previous lumbar fusion, multi-segment fusion, multi-level, high-grade (Meyerding grade 3 or 4) isthmic spondylolisthesis or degenerative spondylolisthesis.

Study Design


Intervention

Other:
Surgery(OLIF and MIS-TLIF)
oblique lateral interbody fusion (OLIF); minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tang-Du Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Oswestry Disability Index (ODI), , and Short Form-36 (SF-36) scores; discal and foraminal height; lumbar lordotic angle; and fusion status. Before surgery and at the last follow-up, the following information was recorded 2 Years
Secondary Japanese Orthopaedic Association (JOA) Before surgery and at the last follow-up, the following information was recorded 2 Years
Secondary visual analogue scale (VAS) Before surgery and at the last follow-up, the following information was recorded 2 Years
Secondary Short Form-36 (SF-36) scores Before surgery and at the last follow-up, the following information was recorded 2 Years
Secondary Major Complication rate 2 Years
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