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Indirect vs. Direct Decompression for Treatment of Central Stenosis: RCT (IDVD)

Primary Purpose

Patients With Spinal Stenosis Indicated for LLIF

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

One-level lateral lumbar interbody fusion with Indirect Decompression

One-level lateral lumbar interbody fusion with Direct Decompression

About this trial

This is an interventional treatment trial for Patients With Spinal Stenosis Indicated for LLIF focused on measuring Lateral Lumbar Interbody Fusion (LLIF), Foraminal Stenosis, Spine Fusion, Decompression, Lumbar

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Fusion indicated by the treating surgeon. Fusion may be indicated for one or more of the following reasons:
- Mobile degenerative spondylolisthesis
- Severe vertical foraminal stenosis
- Adjacent segment degeneration and/or degenerative disc disease with suspected discogenic pain
One-level central canal stenosis
- WITH neurogenic claudication
- As measured in preoperative MRI
Oswestry Low Back Pain Disability Questionnaire score > 35% (18/50)
Failed 3 months of conservative treatment
Willing to give written informed consent and psychosocially, mentally, and physically able to comply fully with protocol, including adhering to follow-up schedule and requirements, and filling out forms

Exclusion Criteria:

Multilevel central canal stenosis
Patients with vertebral endplate dimensions that are too small to allow for safe placement of an intervertebral cage
Known allergy to titanium, polyethylene, cobalt, chromium, or molybdenum
Prior surgery at index disc level (discectomy, decompression, or fusion)
History of spinal or vertebral infection of the lumbar spine
History of vertebral fracture of the lumbar spine
Current pregnancy or interest in becoming pregnant over the next 1 year
Active infection-systemic or local
Non-English speakers

Sites / Locations

Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group 1: Indirect Decompression

Group 2: Direct Decompression

Arm Description

Lateral lumbar interbody fusion (LLIF), with indirect decompression

Lateral lumbar interbody fusion (LLIF), with direct decompression

Outcomes

Primary Outcome Measures

Oswestry Disability Index (ODI)

Change in Oswestry Disability Index (ODI) 100 point scale. The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools [1]. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated by adding all scores for each statement, divided by 50 total possible points, and then multiplied by 100 for a percentage. Percentage scores are interpreted on a scale from 0-20% as minimal disability to 61-100% as crippled.

Comparison of Oswestry Disability Index (ODI)

Compare ODI scores to assess the kinetics of improvement in the control (direct decompression) vs. treatment (indirect decompression) groups. The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools [1]. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated by adding all scores for each statement, divided by 50 total possible points, and then multiplied by 100 for a percentage. Percentage scores are interpreted on a scale from 0-20% as minimal disability to 61-100% as crippled.

Secondary Outcome Measures

Reoperation Rate

Reoperation rate on the lumbar spine within 12 months and within 24 months

Complication Rate

Complication rate within 12 months and within 24 months

Numeric Rated Scale (NRS)-Back and Leg pain

Patient Reported Outcomes: Numeric Rated Scale (NRS)-back and leg pain scores

Radiographic Measurements - Lumbar Lordosis

Radiographic measurements at 12 months will be compared to preoperative measurements to quantify the change in lumbar lordosis as a result of Lateral Lumbar Interbody Fusion (LLIF). Measurements will be taken in millimeters by (2) co-investigators.

Radiographic Measurements - Segmental Lordosis

Radiographic measurements at 12 months will be compared to preoperative measurements to quantify the change in segmental lordosis as a result of Lateral Lumbar Interbody Fusion (LLIF). Measurements will be taken in millimeters by (2) co-investigators.

Radiographic Measurements - Disc Space Height

Radiographic measurements at 12 months will be compared to preoperative measurements to quantify the change in disc space height as a result of Lateral Lumbar Interbody Fusion (LLIF). Measurements will be taken in millimeters by (2) co-investigators.

Full Information

NCT ID

NCT04708977

First Posted

December 22, 2020

Last Updated

October 4, 2021

Sponsor

Hospital for Special Surgery, New York

1. Study Identification

Unique Protocol Identification Number

NCT04708977

Brief Title

Indirect vs. Direct Decompression for Treatment of Central Stenosis: RCT

Acronym

IDVD

Official Title

Is Indirect Decompression Sufficient for the Treatment of Central Stenosis?: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Withdrawn

Why Stopped

The patient population is too low to conduct the study in a feasible and meaningful amount of time.

Study Start Date

February 8, 2021 (Actual)

Primary Completion Date

September 29, 2021 (Actual)

Study Completion Date

September 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital for Special Surgery, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a prospective, randomized clinical trial of patients undergoing 1-level lateral lumbar spinal fusion. This study seeks to randomize patients indicated for Lateral Lumbar Interbody Fusion (LLIF) into one of two groups: direct decompression and indirect decompression.

Detailed Description

While indirect decompression has been largely accepted as a strategy to treat foraminal stenosis, there is some disagreement regarding its efficacy in treating patients with central and lateral recess stenosis. The current study seeks to randomize patients indicated for Lateral Lumbar Interbody Fusion (LLIF) into one of two groups: direct decompression and indirect decompression. Enrolled participants will be evaluated before surgery, during their hospital course and post-operatively at 6 weeks, 3 months, 6 months, 1 and 2 years. Operative details, complications, reoperation rates, patient reported outcomes, clinical and radiographic outcome measures will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients With Spinal Stenosis Indicated for LLIF

Keywords

Lateral Lumbar Interbody Fusion (LLIF), Foraminal Stenosis, Spine Fusion, Decompression, Lumbar

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This is a single-center, prospective, randomized controlled trial.

Masking

Participant

Masking Description

Patients will be blinded to randomization and surgical technique will not be evident based on postoperative radiographs. Research coordinators, surgeons, principal investigator (assisting with randomization) and other co-investigators will not be blinded to the type of surgical procedure performed.

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Indirect Decompression

Arm Type

Active Comparator

Arm Description

Lateral lumbar interbody fusion (LLIF), with indirect decompression

Arm Title

Group 2: Direct Decompression

Arm Type

Active Comparator

Arm Description

Lateral lumbar interbody fusion (LLIF), with direct decompression

Intervention Type

Procedure

Intervention Name(s)

One-level lateral lumbar interbody fusion with Indirect Decompression

Intervention Description

One-level lateral lumbar interbody fusion, with or without percutaneous posterior instrumentation. Thorough discectomy will be performed using lateral access. Fusion will then be performed using lateral access interbody cage and allograft bone graft with or without use of recombinant human bone morphogenic protein 2.

Intervention Type

Procedure

Intervention Name(s)

One-level lateral lumbar interbody fusion with Direct Decompression

Intervention Description

One-level lateral lumbar interbody fusion, with or without percutaneous posterior instrumentation. Thorough discectomy will be performed using lateral access instruments. Fusion will then be performed using lateral access interbody cage and allograft bone graft with or without use of recombinant human bone morphogenic protein 2. Additionally, direct decompression through midline or parasagittal approach will be utilized. A unilateral laminotomy or complete bilateral laminectomy may be performed.

Primary Outcome Measure Information:

Title

Oswestry Disability Index (ODI)

Description

Time Frame

Up to 12 months post-operatively

Title

Comparison of Oswestry Disability Index (ODI)

Description

Time Frame

Up to 24 months post-operatively. (6 weeks, 3, 6, 12, and 24 months timepoints)

Secondary Outcome Measure Information:

Title

Reoperation Rate

Description

Reoperation rate on the lumbar spine within 12 months and within 24 months

Time Frame

Within 12 months and 24 months, post-operatively.

Title

Complication Rate

Description

Complication rate within 12 months and within 24 months

Time Frame

Within 12 months and 24 months, post-operatively.

Title

Numeric Rated Scale (NRS)-Back and Leg pain

Description

Patient Reported Outcomes: Numeric Rated Scale (NRS)-back and leg pain scores

Time Frame

6- Weeks, 3-, 6-, 12-, and 24-Months.

Title

Radiographic Measurements - Lumbar Lordosis

Description

Time Frame

Preoperative and 12-Month radiographs

Title

Radiographic Measurements - Segmental Lordosis

Description

Time Frame

Preoperative and 12-Month radiographs

Title

Radiographic Measurements - Disc Space Height

Description

Time Frame

Preoperative and 12-Month radiographs

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Fusion indicated by the treating surgeon. Fusion may be indicated for one or more of the following reasons: Mobile degenerative spondylolisthesis Severe vertical foraminal stenosis Adjacent segment degeneration and/or degenerative disc disease with suspected discogenic pain One-level central canal stenosis WITH neurogenic claudication As measured in preoperative MRI Oswestry Low Back Pain Disability Questionnaire score > 35% (18/50) Failed 3 months of conservative treatment Willing to give written informed consent and psychosocially, mentally, and physically able to comply fully with protocol, including adhering to follow-up schedule and requirements, and filling out forms Exclusion Criteria: Multilevel central canal stenosis Patients with vertebral endplate dimensions that are too small to allow for safe placement of an intervertebral cage Known allergy to titanium, polyethylene, cobalt, chromium, or molybdenum Prior surgery at index disc level (discectomy, decompression, or fusion) History of spinal or vertebral infection of the lumbar spine History of vertebral fracture of the lumbar spine Current pregnancy or interest in becoming pregnant over the next 1 year Active infection-systemic or local Non-English speakers

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sravisht Iyer, MD

Organizational Affiliation

Hospital for Special Surgery, New York

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital for Special Surgery

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Only the PI, study coordinators listed on the IRB protocol, and co-investigators will have access to the IPD information.

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Indirect vs. Direct Decompression for Treatment of Central Stenosis: RCT

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