Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT04795284 - Biomechanical Parameters of Gait in Patients With Symptomatic Lumbar Spinal Stenosis and Healthy Elderly.
Recruiting NCT04066296 - Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine Phase 2
Active, not recruiting NCT05114135 - TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study) N/A
Recruiting NCT06057428 - Activity Levels Amongst Patients With Lumbar Spinal Stenosis
Recruiting NCT06075862 - Balance Amongst Patients With Lumbar Spinal Stenosis
Recruiting NCT05527145 - Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial N/A
Recruiting NCT01902979 - The Spinal Stenosis Pedometer and Nutrition e-Health Lifestyle Intervention (SSPANLI) Trial N/A
Completed NCT00749073 - The Vertos MILD™ Preliminary Patient Evaluation Study N/A
Completed NCT00527527 - Chiropractic Dosage for Lumbar Stenosis Phase 2
Completed NCT00405691 - Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis Phase 3
Completed NCT03194607 - Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal Stenosis
Recruiting NCT06034405 - Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Completed NCT06079580 - Patients With Lumbar Spinal Stenosis With Balance Disorder
Recruiting NCT05523388 - Role of Spinal Load in the Pathophysiology of Lumbar Spinal Stenosis
Completed NCT04587401 - The Effects of Anesthesia on Cerebral Perfusion in Patients With High Blood Pressure N/A
Completed NCT04563793 - Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
Suspended NCT03381677 - Pedicle Osteotomy for Stenosis Trial N/A
Completed NCT02258672 - Preoperative Rehabilitation for Patients Undergoing Surgery for Lumbar Spinal Stenosis N/A
Completed NCT02260401 - Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis N/A
Completed NCT00401518 - A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis N/A