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Completed

NCT Number: NCT03002207

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

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.

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Hospital

Tianjin, 300211, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge

Device

Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and the defect of intervertebral disc is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.

The defect is sutured

Procedure

Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and the defect is sutured after discectomy.

Primary outcomes

  1. Changes from baseline in Oswestry Disability Index(ODI)

    Time frame: 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 outcomes

  1. Changes from baseline in Visual Analogue Scale(VAS)

    Time frame: 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)

  2. Changes from baseline in The Short Form (36) Health Survey(SF-36)

    Time frame: 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.

  3. Change from Baseline in Magnetic Resonance Classification of Lumbar Intervertebral Disc Degeneration（Pfirrmann classification）

    Time frame: 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。

  4. Change from Baseline in The Height of Disc on MRI Scans

    Time frame: Baseline, post-op 12 months

    Using imaging software, physicians will measure disc height at the treatment discs on the midline T1 sagittal view

  5. Change from Baseline in The Size of Disc Protrusion

    Time frame: Baseline, post-op 12 months

    We will measure the anteroposterior (AP) size of the disc protrusions that required treatment

Other outcomes

  1. The Medical Records

    Time frame: 1 months after hospital discharge

    The Medical Records including operative time、blood loss and hospital stay

Sponsors and collaborators

Lead sponsor

Zhanghao

Other

Registry information

Official study title

A Prospective, Comparative Study to Evaluate Effectiveness of Repairing the Defect of Intervertebral Disc With Autologous BMSC and Gelatin Sponge After Microendoscopic Discectomy for Lumbar Disc Herniation

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Dec 23, 2016
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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