NCT04538027

Brief Summary

97 patients in 3 randomized groups were treated by Microdiscectomy for lumbar disc herniation; Group A was operated at 6 weeks of symptoms, Group B at 3 months and group C at 6 months. These patients were followed for 3 years for the clinical and functional outcomes.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

4.1 years

First QC Date

August 25, 2020

Last Update Submit

September 1, 2020

Conditions

Lumbar Disc Herniation

Keywords

Duration of symptomsOutcomesLumbar MicrodiscectomyOswestry disability indexRoland-Morris Questionnaire

Outcome Measures

Primary Outcomes (2)

  • Oswestry disability index

    Primary outcome measure for functional disability, the higher score is better function

    Oswestry disability index was measured the functional disability at 2 weeks

  • Roland-Morris Questionnaire

    Primary outcome measure for functional disability, the higher score is worse function

    Roland-Morris Questionnaire was measured the functional disability at 2 weeks

Secondary Outcomes (3)

  • Visual analogue scale

    Visual analogue scale was measured at 2 weeks

  • Length of hospital stay

    Measuring the days of postoperative hospital stay immediately after the surgery

  • Return to daily activities

    Measuring the time needed t return to daily activities immediately after the surgery

Study Arms (3)

6 weeks

ACTIVE COMPARATOR

Microdiscectomy was done at 6 weeks of starting symptoms

Procedure: Lumbar Microdiscectomy at 6 weeks of symptoms

3 months

ACTIVE COMPARATOR

Microdiscectomy was done at 3 months of starting symptoms

Procedure: Lumbar Microdiscectomy at 3 months of symptoms

6 months

ACTIVE COMPARATOR

Microdiscectomy was done at 6 months of starting symptoms

Procedure: Lumbar Microdiscectomy at 6 months of symptoms

Interventions

Lumbar Microdiscectomy at 6 weeks of symptomsPROCEDURE

Microscope assisted lumbar discectomy done at 6 weeks of starting symptoms

6 weeks
Lumbar Microdiscectomy at 3 months of symptomsPROCEDURE

Microscope assisted lumbar discectomy done at 3 months of starting symptoms

3 months
Lumbar Microdiscectomy at 6 months of symptomsPROCEDURE

Microscope assisted lumbar discectomy done at 6 months of starting symptoms

6 months

Eligibility Criteria

Age19 Years - 47 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age more than 18 years
  • Disc herniation of L3-4, L4-5 or L5-S1
  • MRI showed disc protrusion or extrusion with nerve root compression corresponding to clinical features.

You may not qualify if:

  • Spondylolysis or spondylolisthesis.
  • Spinal deformity like scoliosis.
  • Previous spinal surgery or infection.
  • Cauda equina syndrome.
  • Lumbar segmental instability on dynamic radiograph: translation more than 3 mm or change in angulation more than 10 degrees
  • Smoking
  • Diabetes Mellitus
  • Disc herniation other than levels L3-L4, L4-L5 and L5-S1
  • More than single level disc hernaition.
  • Body mass index 30 or more than 30
  • Contained disc herniation by MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of orthopedic surgery

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 3, 2020

Study Start

January 3, 2016

Primary Completion

February 15, 2020

Study Completion

February 20, 2020

Last Updated

September 3, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share