Results of Mini-open Discectomy According to Sagittal Profile

June 28, 2023 updated by: İsmail Demirkale, Saglik Bilimleri Universitesi

Does the Sagittal Profile of the Patient Effect the Results of Mini-open Lumbar Discectomy? A Preliminary Mid-term Results Report

In the normal healthy population, the sagittal alignment can be divided into four types based on the size of the sacral slope and lumbar lordosis. The effect of this sagittal profile especially type 2 with almost straight lordosis on the clinical outcomes of patients after mini-open discectomy is unknown. In this study, the results of patients who underwent mini-open discectomy were evaluated according to sagittal profile types of the patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lumbar disc herniation (LDH) is the most common cause of sciatica and when conservative treatment fails or there is progressive neurological deficit, surgical excision of the herniated nucleosus pulposus is standard of care. Although minimally invasive methods such as endoscopic discectomy have been tried to be popular in recent years, open lumbar discectomy is still successfully performed in lumbar disc herniations due to some drawbacks of endoscopic techniques such as having long learning curve, higher radiation exposure to the surgeon, similar long-term results or the deception of commercial enterprises about endoscopic techniques and the pressure placed on surgeons in this direction.

Herniation of the nucleus pulposus as a result of massive LDH will inevitably result in disruption of normal lumbar biomechanics. Moreover, it has been shown that the healing process of the posterolateral herniation, which is biologically the weakest part of the posterior longitudinal ligament, will cause disc degeneration as a result of the repair and inflammation process in the annulus. However, the same authors claimed that, unlike the process in discogenic low back pain, macrophages in herniated discs can act to remove free pulposus fragments. There are few studies in the literature about the long-term consequences of this degeneration, which the investigators can consider as an accelerated aging process. Although clinically very successful results are obtained in the early postoperative period, it has been reported that the long-term success after discectomy may decrease from 90% to 60% over time. Depression or somatization, strenuous job and recurrent disc herniation or degeneration have been shown to cause long-term regression of results. In a prospective cohort study the authors reported a similar or worse leg pain rate in 30% of patients at the end of 10 years. In a study investigating reoperation after open lumbar discectomy, it was reported that the estimated rate of reoperation reached almost 45% at the end of 30 years.

In an extraordinary review evaluating the spinopelvic organization and the pathological adaptation to it, the mechanical stress, especially increased by hypolordosis, would cause the degenerative process in the spine to progress more rapidly. The basic theories explaining this are that the contact force, which is defined as the resultant force of the system created by gravity and abdominal pressure from the front and the dense paraspinal muscle mass from the posterior, mainly targets the discs. However, studies evaluating spinopelvic orientation in patients with LDH are limited. In a case-control study investigating the relationship between sciatica and spinopelvic harmony, more vertical sacrum, anterior C7 plumb line and hypolordosis were found in the LDH group. In a study examining the etiology and mechanism of sagittal imbalance caused by LDH, lumbar lordosis improved almost twice after endoscopic discectomy and LDH is probably one of the causes of compensatory sagittal imbalance.

Although there are studies on the pathogenesis and mechanics of LDH's etiology and post-discectomy results, the effect of the generally accepted normal lordosis types described by Roussouly P. on the degenerative process and patient scores after open standard discectomy is unknown. Therefore, in this study, the investigators aimed to compare the clinical results of patients with hypolordotic Type 2 and other types after open discectomy. Our hypothesis is that the mid-term clinical scores will be worse in Roussouly Type 2 patients with less lordosis.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Atatürk Sanatoryum SUAM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with lumbar disc herniation who are candidates for surgical treatment

Description

Inclusion Criteria:

  • Patients with complete skeletal maturation (>18 years)
  • Lumbar disc herniation with >50% canal narrowing
  • Severe leg and back pain associated with large LDH
  • >6 weeks of unsuccessful conservative treatment
  • Signed a written consent form

Exclusion Criteria:

  • Patients with spondyloarthropathy
  • Recurrent disc herniation
  • Spinal instability
  • >10 degrees of coronal deformity
  • Incomplete data in the records

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 2
Patients with Roussouly type 2 sagittal profile
Procedure: lumbar discectomy
mini-open discectomy
Type 1,3,4
Patients with other Roussouly type sagittal profiles (1,3,4)
Procedure: lumbar discectomy
mini-open discectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI)
Time Frame: change between preoperative and postoperative last (12th month) control
quantify disability for low back pain
change between preoperative and postoperative last (12th month) control
Japanese Orthopedic Association scores
Time Frame: at 12th month control
a simple scoring measure for radiculopathy with 29 points: Excellent neurological function 25-28 points: Good neurological function 17-24 points: Fair neurological function 11-16 points: Poor neurological function 10 points and below: Bad neurological function
at 12th month control

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index (kg/cm2)
Time Frame: preoperative
demographic characteristic
preoperative
abdominal diameter
Time Frame: preoperative
radiological assessment of coronal abdominal diameter, cm
preoperative
classification of disc degeneration
Time Frame: change between preoperative and at 12th month control

Pfirrmann grading scale for intervertebral disc degeneration where Grade I: Normal disc appearance with high signal intensity, a smooth contour, and high water content.

Grade II: Mild signs of degeneration with slightly decreased high signal intensity compared to normal discs.

Grade III: Moderate degeneration with an irregular contour, further decreased high signal intensity, and possible small fissures within the disc.

Grade IV: Severe degeneration with a more pronounced irregularity, significant decrease in high signal intensity, and presence of larger fissures and herniations within the disc.

Grade V: Advanced degeneration with a substantially decreased signal intensity, loss of contour, and structural integrity of the disc. Large herniations may be present within the disc.
change between preoperative and at 12th month control
visual analogue scale
Time Frame: change between preoperative and postoperative 1st, 6th and 12th month controls
pain rating scale from 0 (no pain) to 10 (maximum pain)
change between preoperative and postoperative 1st, 6th and 12th month controls
Tanita-SC 240 body analysis
Time Frame: preoperative and 12th month control
Body fat percentages of the patients
preoperative and 12th month control
sagittal abdominal diameter
Time Frame: preoperatively
radiological assessment of sagittal abdominal diameter, cm
preoperatively
ventral subcutaneous thickness
Time Frame: preoperatively
radiological assessment of ventral fat thickness, cm
preoperatively
Adjacent muscle cross-sectional areas (cm2)
Time Frame: preoperatively
Musculus Multifidus, Erector spina and Psoas muscle cross-sectional areas
preoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Investigators

  • Study Chair: süheyla atay, Saglik Bilimleri Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

February 6, 2023

Study Registration Dates

First Submitted

June 8, 2023

First Submitted That Met QC Criteria

June 28, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012KAEK15-2603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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