Comparison of Endoscopic Lumbar Decompression and Minimally Invasive Transforaminal Lumbar Interbody Fusion(MIS-TLIF) for Degenerative Lumbar Spondylolisthesis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorQueen Savang Vadhana Memorial Hospital, Thailand

About this trial

Comparing the functional and radiographic outcomes in surgical treatment in failed conservative treatment, single-level low grade degenerative lumbar spondylolisthesis between Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion, which is conventional treatment recently, and Endoscopic Lumbar Decompression, which is minimal invasive in symptomatic treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Single level lumbar degenerative spondylolisthesis (Meyerding Grading Grade I or II).

Failed conservative treatment for at least 3 months.

No instability evidence of levels of lesion (Consideration from translation more than 5 mm or angulation change more than 10 degree in flexion and extension L-S plain films ).

Able to follow up for at least 12 months.

Disqualifiers

Patients with severe foraminal stenosis diagnosed by MRI.

Patients who have previously undergone lumbar spine surgery (revision surgery).

Patients with other abnormalities in the lumbar spine, such as infection, tumors, or fractures.

Patients who cannot undergo surgery due to underlying conditions or who cannot maintain the prone position for extended periods.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression

    Procedure/Surgery

    The LE-ULBD: Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression is a single portal through lamina with instrument to decompression both side of the spinal canal, giving strength of preserve facet joint, preserve spinal musculature, mitigate the risk of adjacent fusion and lesser bleeding

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Lumbar Endoscopic - Unilateral Laminotomy for Bilateral DecompressionExperimental treatment 1 intervention
Group B: MIS-TLIF: Minimal Invasive Surgery - Transforaminal Lumbar interbody FusionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Oswestry Disability Index score

The Oswestry Disability Index (ODI) is a patient-completed questionnaire made up of 10 questions, each with six statements that are scored from 0 to 5. The questions cover a range of activities, including pain intensity, personal care, walking, sleeping, social life, and travel. The ODI score ranges from 0% to 100%, with higher scores indicating more severe disability: 0-20%: Mild disability 20-40%: Moderate disability 40-60%: Severe disability 60-80%: Disabling 80-100%: Bedridden or functional impairment

Time frame
1 year; Preoperative and post-operative at 12 months

Secondary outcomes

1

Visual analog scale of leg pain

Pain score of leg pain from 1-10 determined by measuring in millimeters from the left hand end of the line to the point that the patient marks

Time frame
1 year; Preoperative and post-operative at 1,3,6 and 12 months
2

Visual analog scale of back pain

Pain score of back pain from 1-10 determined by measuring in millimeters from the left hand end of the line to the point that the patient marks

Time frame
1 year; Preoperative and post-operative at 1,3,6 and 12 months
3

Modified Macnab criteria

The Modified MacNab criteria are a set of guidelines used to assess the outcomes of spinal surgery, particularly in evaluating the effectiveness of procedures like discectomy or spinal fusion

Time frame
1 year; Preoperative and post-operative at 1,3,6 and 12 months
4

Operative time

Operative time that using in each intervention start from when patient's skin is cut and stop when it is closed. Measure in minute

Time frame
1 day; From patient's skin is cut, through each intervention surgery completion (minute) when the skin is closed

Other outcomes

Sponsors and contacts

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