Repairing the Defect of Intervertebral Disc With Autologous BMSC and Gelatin Sponge After Microendoscopic Discectomy for Lumbar Disc Herniation

Not Applicable

Completed

• Conditions: Lumbar Disc Herniation
• Interventions: Device: Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge; Procedure: The defect is sutured

• Registration Number: NCT03002207
• Lead Sponsor: Zhanghao

Brief Summary

In this prospective study the investigators seek to evaluate clinical outcomes after repairing the defect of intervertebral disc with autologous BMSC/gelatin sponge during microendoscopic discectomy for participants of lumbar disc herniation.

Detailed Description

The participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the first group,the defect of intervertebral disc is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge and sutured. In the second group, the defect of intervertebral disc is repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge but not sutured after discectomy. In the third group, the defect of intervertebral disc is sutured but not repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy. In the four group, the defect of intervertebral disc is neither sutured nor repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-12-10
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-23
• Status Verified: 2021-10
• Primary Completion: 2024-12-20
• Last Update Submitted: 2024-12-21
• Study Completion: 2024-12-22
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Participants with signs and symptoms of lumbar disc herniation requiring surgical treatment after conservative management;
2. Radiological data on CT/MRI obtained within a period prior to enrollment;
3. Participants give written informed consent before enrollment.

Exclusion Criteria

1. If participants had an incomplete medical record;
2. Participants had spine tumor, spine infection, previous underwent lumbar surgery, or revision surgery.
3. Participants are taking uninterruptible anticoagulation therapy.
4. Dementia and/or inability to give informed consent.
5. MRI contraindication (e.g. cerebral aneurysm clips, cochlear implants, pacemaker, implanted biostimulators);
6. Pregnancy;
7. Participation in other clinical trial within the last 30 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The defect is repaired and sutured	Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge	Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the first group,the defect of intervertebral disc is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge and sutured.
The defect is sutured but not repaired	The defect is sutured	Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the third group, the defect of intervertebral disc is sutured but not repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.
The defect is repaired and sutured	The defect is sutured	Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the first group,the defect of intervertebral disc is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge and sutured.
The defect is repaired but not sutured	Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge	Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the second group, the defect of intervertebral disc is repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge but not sutured after discectomy.

Primary Outcome Measures

Name	Time	Method
Changes from baseline in Oswestry Disability Index(ODI)	Baseline, post-op 3 months, 6 months,12 months	The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in Visual Analogue Scale(VAS)	Baseline, post-op 3 months, 6 months,12 months	Self reported pain using a 10-point visual analogue scale (0=no pain;10=pain as bad as can be)
Change from Baseline in Magnetic Resonance Classification of Lumbar Intervertebral Disc Degeneration（Pfirrmann classification）	Baseline, post-op 12 months	The Pfirrmann grading system assesses degenerated intervertebral discs by MRI for the asymmetry in disc structure, distinction of the nucleus and the annulus, signal intensity of intervertebral discs and height of intervertebral discs and assigns grade I to V for disc degeneration。
Change from Baseline in The Height of Disc on MRI Scans	Baseline, post-op 12 months	Using imaging software, physicians will measure disc height at the treatment discs on the midline T1 sagittal view
Changes from baseline in The Short Form (36) Health Survey(SF-36)	Baseline, post-op 3 months, 6 months,12 months	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Change from Baseline in The Size of Disc Protrusion	Baseline, post-op 12 months	We will measure the anteroposterior (AP) size of the disc protrusions that required treatment

Trial Locations

Locations (1)

Tianjin Hospital; 🇨🇳 Tianjin, China