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NCT06290908

RPE-P/TLIF for Lumbar Spinal Stenosis With Instability

Completed Last updated 4 March 2024
What this trial tests

trial testing RPE-P/TLIF in Spinal Stenosis in 26 participants. Completed in 1 February 2024.

Timeline
4 September 2018
Primary endpoint
30 April 2022
1 February 2024

Quick facts

Lead sponsorWen-xi Sun
StatusCompleted
Study typeOBSERVATIONAL
Enrollment26
Start date4 September 2018
Primary completion30 April 2022
Estimated completion1 February 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Wen-xi Sun

Who can join

Adults 18 to 80, any sex, with Spinal Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objective To analyze the effectiveness and safety of robot-assisted percutaneous endoscopic posterior/transforaminal lumbar interbody fusion (RPE-P/TLIF) in the treatment of lumbar spinal stenosis with instability. Methods A single-center prospective study from September 2018 to April 2022, patients with lumbar spinal stenosis and instability who met the inclusion and exclusion criteria were treated with RPE-P/TLIF. Pain visual analog scale (VAS) was used to evaluate the degree of low back pain and lower limb pain before operation, 1 month, 6 months, 1 year after operation and at the final follow-up, and the Oswestry disability index (ODI) was used to evaluate the degree of lumbar spinal function. At the last follow-up, MacNab criteria were used to evaluate the clinical efficacy. Imaging evaluation included the measurement of intervertebral space height, lumbar physiological curvature, fusion rate and pedicle screw accuracy by preoperative and lateral X-ray films.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Currently open trials in the same condition.

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