Patients With Spinal Stenosis Indicated for LLIFIDVDNCT04708977

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

A study testing One-level lateral lumbar interbody fusion with Indirect Decompression and One-level lateral lumbar interbody fusion with Direct Decompression in people with Patients With Spinal Stenosis Indicated for LLIF, run by Hospital for Special Surgery, New York at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Patients With Spinal Stenosis Indicated for LLIF
What is being tested?: One-level lateral lumbar interbody fusion with Indirect Decompression and One-level lateral lumbar interbody fusion with Direct Decompression
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 8 Feb 2021to 29 Sep 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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

Who cannot join

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

Show all 9Show fewer

Current pregnancy or interest in becoming pregnant over the next 1 year
Active infection-systemic or local
Non-English speakers

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital for Special Surgery
New York, New York, 10021

Other trials in United States

About this study

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

Read the 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.

Conditions: Patients With Spinal Stenosis Indicated for LLIF
Being tested: One-level lateral lumbar interbody fusion with Indirect Decompression, One-level lateral lumbar interbody fusion with Direct Decompression
Keywords: Lateral Lumbar Interbody Fusion (LLIF), Foraminal Stenosis, Spine Fusion, Decompression, Lumbar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

One-level lateral lumbar interbody fusion with Indirect DecompressionProcedure or surgery
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.
One-level lateral lumbar interbody fusion with Direct DecompressionProcedure or surgery
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.

Study groups in NCT04708977
Study group	Role	What they receive
Group 1: Indirect Decompression	Active comparator	Lateral lumbar interbody fusion (LLIF), with indirect decompression Receives: Procedure: One-level lateral lumbar interbody fusion with Indirect Decompression
Group 2: Direct Decompression	Active comparator	Lateral lumbar interbody fusion (LLIF), with direct decompression Receives: Procedure: One-level lateral lumbar interbody fusion with Direct Decompression

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

Reoperation Rate
Reoperation rate on the lumbar spine within 12 months and within 24 months
Measured: Within 12 months and 24 months, post-operatively.
Complication Rate
Complication rate within 12 months and within 24 months
Measured: Within 12 months and 24 months, post-operatively.
Numeric Rated Scale (NRS)-Back and Leg pain
Patient Reported Outcomes: Numeric Rated Scale (NRS)-back and leg pain scores
Measured: 6- Weeks, 3-, 6-, 12-, and 24-Months.
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.
Measured: Preoperative and 12-Month radiographs
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.
Measured: Preoperative and 12-Month radiographs
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.
Measured: Preoperative and 12-Month radiographs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 202129 Sep 2021

First posted14 Jan 2021
Study start8 Feb 2021
Primary completion29 Sep 2021
Study completion29 Sep 2021

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

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Patients With Spinal Stenosis Indicated for LLIFStudies of the same condition, open and under way.
More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a single-center, prospective, randomized controlled trial.
Masking: Single blind
Who is masked: Participant
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04708977
Sponsor's protocol ID: 2019-2228
Acronym: IDVD
Status last verified: Oct 2021
First submitted: 22 Dec 2020
Last updated: 11 Oct 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Only the PI, study coordinators listed on the IRB protocol, and co-investigators will have access to the IPD information.

Publications

Grant S, Aitchison T, Henderson E, Christie J, Zare S, McMurray J, Dargie H. A comparison of the reproducibility and the sensitivity to change of visual analogue scales, Borg scales, and Likert scales in normal subjects during submaximal exercise. Chest. 1999 Nov;116(5):1208-17. doi: 10.1378/chest.116.5.1208.
PubMed 10559077
Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
PubMed 16320034
Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
PubMed 11074683
Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.
PubMed 6450426
Fujibayashi S, Hynes RA, Otsuki B, Kimura H, Takemoto M, Matsuda S. Effect of indirect neural decompression through oblique lateral interbody fusion for degenerative lumbar disease. Spine (Phila Pa 1976). 2015 Feb 1;40(3):E175-82. doi: 10.1097/BRS.0000000000000703.
PubMed 25394317
Isaacs RE, Sembrano JN, Tohmeh AG; SOLAS Degenerative Study Group. Two-Year Comparative Outcomes of MIS Lateral and MIS Transforaminal Interbody Fusion in the Treatment of Degenerative Spondylolisthesis: Part II: Radiographic Findings. Spine (Phila Pa 1976). 2016 Apr;41 Suppl 8:S133-44. doi: 10.1097/BRS.0000000000001472.
PubMed 26839992
Kono Y, Gen H, Sakuma Y, Koshika Y. Comparison of Clinical and Radiologic Results of Mini-Open Transforaminal Lumbar Interbody Fusion and Extreme Lateral Interbody Fusion Indirect Decompression for Degenerative Lumbar Spondylolisthesis. Asian Spine J. 2018 Apr;12(2):356-364. doi: 10.4184/asj.2018.12.2.356. Epub 2018 Apr 16.
PubMed 29713419
Nakashima H, Kanemura T, Satake K, Ishikawa Y, Ouchida J, Segi N, Yamaguchi H, Imagama S. Indirect Decompression on MRI Chronologically Progresses After Immediate Postlateral Lumbar Interbody Fusion: The Results From a Minimum of 2 Years Follow-Up. Spine (Phila Pa 1976). 2019 Dec 15;44(24):E1411-E1418. doi: 10.1097/BRS.0000000000003180.
PubMed 31365515
Pimenta L. Less-invasive lateral lumbar interbody fusion (XLIF) surgical technique: video lecture. Eur Spine J. 2015 Apr;24 Suppl 3:441-2. doi: 10.1007/s00586-015-3948-4. No abstract available.
PubMed 25904416
Ozgur BM, Aryan HE, Pimenta L, Taylor WR. Extreme Lateral Interbody Fusion (XLIF): a novel surgical technique for anterior lumbar interbody fusion. Spine J. 2006 Jul-Aug;6(4):435-43. doi: 10.1016/j.spinee.2005.08.012.
PubMed 16825052
Smith ZA, Sugimoto K, Lawton CD, Fessler RG. Incidence of lumbar spine pedicle breach after percutaneous screw fixation: a radiographic evaluation of 601 screws in 151 patients. J Spinal Disord Tech. 2014 Oct;27(7):358-63. doi: 10.1097/BSD.0b013e31826226cb.
PubMed 22688617
Baird EO, McAnany SJ, Overley S, Skovrlj B, Guzman JZ, Qureshi SA. Accuracy of Percutaneous Pedicle Screw Placement: Does Training Level Matter? Clin Spine Surg. 2017 Jul;30(6):E748-E753. doi: 10.1097/BSD.0000000000000274.
PubMed 28632564
Sellin JN, Mayer RR, Hoffman M, Ropper AE. Simultaneous lateral interbody fusion and pedicle screws (SLIPS) with CT-guided navigation. Clin Neurol Neurosurg. 2018 Dec;175:91-97. doi: 10.1016/j.clineuro.2018.10.013. Epub 2018 Oct 23.
PubMed 30384122
Houten JK, Nasser R, Baxi N. Clinical assessment of percutaneous lumbar pedicle screw placement using theO-arm multidimensional surgical imaging system. Neurosurgery. 2012 Apr;70(4):990-5. doi: 10.1227/NEU.0b013e318237a829.
PubMed 21946509
Jain D, Manning J, Lord E, Protopsaltis T, Kim Y, Buckland AJ, Bendo J, Fischer C, Goldstein J. Initial Single-Institution Experience With a Novel Robotic-Navigation System for Thoracolumbar Pedicle Screw and Pelvic Screw Placement With 643 Screws. Int J Spine Surg. 2019 Oct 31;13(5):459-463. doi: 10.14444/6060. eCollection 2019 Oct.
PubMed 31741833

Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Is Indirect Decompression Sufficient for the Treatment of Central Stenosis?: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04708977
Acronym / sponsor ID: IDVD / 2019-2228
Conditions: Patients With Spinal Stenosis Indicated for LLIF
Keywords: Lateral Lumbar Interbody Fusion (LLIF), Foraminal Stenosis, Spine Fusion, Decompression, Lumbar
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The patient population is too low to conduct the study in a feasible and meaningful amount of time.
Enrolment: 0 participants (actual)
Lead sponsor: Hospital for Special Surgery, New YorkUniversity, hospital or other
Study start: 8 Feb 2021 (actual)
Primary completion: 29 Sep 2021 (actual)
Study completion: 29 Sep 2021 (actual)
First posted: 14 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: This is a single-center, prospective, randomized controlled trial.

Arm	Type	Receives
Group 1: Indirect Decompression	Active comparator	Procedure: One-level lateral lumbar interbody fusion with Indirect DecompressionLateral lumbar interbody fusion (LLIF), with indirect decompression
Group 2: Direct Decompression	Active comparator	Procedure: One-level lateral lumbar interbody fusion with Direct DecompressionLateral lumbar interbody fusion (LLIF), with direct decompression

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Fusion indicated by the treating surgeon. Fusion may be indicated for one or more of the following reasons:
One-level central canal stenosis
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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
One-level lateral lumbar interbody fusion with Indirect DecompressionOne-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.	Procedure or surgery	Group 1: Indirect Decompression
One-level lateral lumbar interbody fusion with Direct DecompressionOne-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.	Procedure or surgery	Group 2: Direct Decompression

Primary outcome

Oswestry Disability Index (ODI)
Time frame: Up to 12 months post-operatively
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)
Time frame: Up to 24 months post-operatively. (6 weeks, 3, 6, 12, and 24 months timepoints)
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.

6 secondary outcomes

Reoperation Rate
Time frame: Within 12 months and 24 months, post-operatively.
Complication Rate
Time frame: Within 12 months and 24 months, post-operatively.
Numeric Rated Scale (NRS)-Back and Leg pain
Time frame: 6- Weeks, 3-, 6-, 12-, and 24-Months.
Radiographic Measurements - Lumbar Lordosis
Time frame: Preoperative and 12-Month radiographs
Radiographic Measurements - Segmental Lordosis
Time frame: Preoperative and 12-Month radiographs
Radiographic Measurements - Disc Space Height
Time frame: Preoperative and 12-Month radiographs

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
Background: PubMed 10559077Grant S, Aitchison T, Henderson E, Christie J, Zare S, McMurray J, Dargie H. A comparison of the reproducibility and the sensitivity to change of visual analogue scales, Borg scales, and Likert scales in normal subjects during submaximal exercise. Chest. 1999 Nov;116(5):1208-17. doi: 10.1378/chest.116.5.1208.
Background: PubMed 16320034Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
Background: PubMed 11074683Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
Background: PubMed 6450426Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.
Background: PubMed 25394317Fujibayashi S, Hynes RA, Otsuki B, Kimura H, Takemoto M, Matsuda S. Effect of indirect neural decompression through oblique lateral interbody fusion for degenerative lumbar disease. Spine (Phila Pa 1976). 2015 Feb 1;40(3):E175-82. doi: 10.1097/BRS.0000000000000703.
Background: PubMed 26839992Isaacs RE, Sembrano JN, Tohmeh AG; SOLAS Degenerative Study Group. Two-Year Comparative Outcomes of MIS Lateral and MIS Transforaminal Interbody Fusion in the Treatment of Degenerative Spondylolisthesis: Part II: Radiographic Findings. Spine (Phila Pa 1976). 2016 Apr;41 Suppl 8:S133-44. doi: 10.1097/BRS.0000000000001472.
Background: PubMed 29713419Kono Y, Gen H, Sakuma Y, Koshika Y. Comparison of Clinical and Radiologic Results of Mini-Open Transforaminal Lumbar Interbody Fusion and Extreme Lateral Interbody Fusion Indirect Decompression for Degenerative Lumbar Spondylolisthesis. Asian Spine J. 2018 Apr;12(2):356-364. doi: 10.4184/asj.2018.12.2.356. Epub 2018 Apr 16.
Background: PubMed 31365515Nakashima H, Kanemura T, Satake K, Ishikawa Y, Ouchida J, Segi N, Yamaguchi H, Imagama S. Indirect Decompression on MRI Chronologically Progresses After Immediate Postlateral Lumbar Interbody Fusion: The Results From a Minimum of 2 Years Follow-Up. Spine (Phila Pa 1976). 2019 Dec 15;44(24):E1411-E1418. doi: 10.1097/BRS.0000000000003180.
Background: PubMed 25904416Pimenta L. Less-invasive lateral lumbar interbody fusion (XLIF) surgical technique: video lecture. Eur Spine J. 2015 Apr;24 Suppl 3:441-2. doi: 10.1007/s00586-015-3948-4. No abstract available.
Background: PubMed 16825052Ozgur BM, Aryan HE, Pimenta L, Taylor WR. Extreme Lateral Interbody Fusion (XLIF): a novel surgical technique for anterior lumbar interbody fusion. Spine J. 2006 Jul-Aug;6(4):435-43. doi: 10.1016/j.spinee.2005.08.012.
Background: PubMed 22688617Smith ZA, Sugimoto K, Lawton CD, Fessler RG. Incidence of lumbar spine pedicle breach after percutaneous screw fixation: a radiographic evaluation of 601 screws in 151 patients. J Spinal Disord Tech. 2014 Oct;27(7):358-63. doi: 10.1097/BSD.0b013e31826226cb.
Background: PubMed 28632564Baird EO, McAnany SJ, Overley S, Skovrlj B, Guzman JZ, Qureshi SA. Accuracy of Percutaneous Pedicle Screw Placement: Does Training Level Matter? Clin Spine Surg. 2017 Jul;30(6):E748-E753. doi: 10.1097/BSD.0000000000000274.
Individual participant dataSharing planned: No. Only the PI, study coordinators listed on the IRB protocol, and co-investigators will have access to the IPD information.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sravisht Iyer, MD principal investigator

Hospital for Special Surgery, New York

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oswestry Disability Index (ODI) (time frame: Up to 12 months post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04708977, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.