Thoracolumbar Spinal FusionsPhase 4NCT03278691
Ketorolac on Posterior Thoracolumbar Spinal Fusions
A Phase 4 study testing Saline and Ketorolac in people with Thoracolumbar Spinal Fusions, run by Henry Ford Health System at 1 site in United States.
Trial summary
To determine is low-dose ketorolac use in the early post-operative period (within 48 hours) provides adequate analgesia without long term adverse effect on spinal fusion rates when compared to post-operative analgesia without the use of NSAIDs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thoracolumbar Spinal Fusions
- What is being tested?
- Saline and Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2017to 31 Dec 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Elective thoracolumbar posterior lumbar instrumented interbody fusion
- Minimally invasive spine surgery (MIS)
- 3 or fewer levels
- Bone Morphogenetic Protein (BMP) use in interbody fusion (1.05mg/level or less)
- Consent to study participation
Who cannot join
- Active tobacco smoker or history of tobacco smoking in the past 6 weeks
- Previous history of surgery at operative level(s)
- History of chronic inflammatory/rheumatological condition
- History of systemic steroid use in the past 3 months
- Auto/Workers' compensation patients
- Traumatic pathology at the operative levels
Show all 16Show fewer
- Infection at the operative levels
- Tumor at the operative levels
- Major psychiatric illness as diagnosed by psychiatrists and on major anti- psychotic/depressants
- Patients on chemotherapeutic agents in the last 6 months
- Patients who has a history of allergy to Ketorolac
- Patients with a history of chemical addiction requiring professional rehabilitation and/or assistance
- Patients with current creatinine > 1.5mg/dl
- Patients with history of coagulopathy
- Patients with history of hepatic impairment
- Patients with uncontrolled cardiovascular disease
Trial locations and contacts
1 site in 1 country.
Chad Claus, DO contact
United States1 site, 1 recruiting
- Recruiting
Providence-Providence Park, Southfield
Southfield, Michigan, 48075
About this study
Official title: The Effect of Ketorolac on Posterior Thoracolumbar Spinal Fusions: a Prospective Randomized Controlled Trial
To determine is low-dose ketorolac use in the early post-operative period (within 48 hours) provides adequate analgesia without long term adverse effect on spinal fusion rates when compared to post-operative analgesia without the use of NSAIDs.
- Conditions
- Thoracolumbar Spinal Fusions
- Being tested
- Saline, Ketorolac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
1 ml saline IV Q6H
KetorolacDrug
15 mg (15 mg/ml) IV Q6H
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo Saline 1 ml IV Q6H Receives: Drug: Saline |
| Intervention | Experimental | Ketorolac 15 mg (15mg/ml) IV Q6H Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Construct X-Ray
Each fusion level will be evaluated individually and as part of the complete fusion construct. Fusion will be evaluated by blinded independent neuroradiologists using XR.
Measured: 6 months postoperatively
Fusion Construct X-Ray
Each fusion level will be evaluated individually and as part of the complete fusion construct. Fusion will be evaluated by blinded independent neuroradiologists using XR.
Measured: 12 months postoperatively
Fusion Construct X-Ray
Each fusion level will be evaluated individually and as part of the complete fusion construct. Fusion will be evaluated by blinded independent neuroradiologists using XR.
Measured: 24 months postoperatively
Secondary outcomes (5)
Visual Analogue Scale (VAS) for pain
- Patient will be given the VAS on the source document in order to draw on the scale
- Blinded investigators
Measured: Every 8 hours x 48 hours postoperatively
Length of Stay (LOS)
-Measured in days (24 hours)
- Automatic data capture on discharge by the hospital EMR
Measured: 12 months postoperatively
Morphine equivalent doses
-Non-study narcotics taken by patients on the floor are converted to morphine equivalent doses
- Morphine equivalent doses are compared between the two groups daily for the first 48h
- Data extracted from hospital EMR on discharge
Measured: 12 months postoperatively
Complications/Adverse events
-Ketorolac-related short term in-hospital complications: GI ulceration and bleeding, GI perforation, PO bleeding, acute renal failure, anaphylactic/anaphylactoid reactions, liver failure
- Collected by investigators daily during round
- Document on the source document
Measured: 12 months postoperatively
Quality of life - long term
Oswestry Disability Index (ODI)
- We will administer validated scales (ODI)
- Face-to -face interview during clinic visit
Measured: 12 months and/or 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start3 Oct 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thoracolumbar Spinal FusionsStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doris Tong, MD, Study director, Michigan Spine and Brain Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278691
- Sponsor's protocol ID
- IRB # 1072359
- Status last verified
- Apr 2023
- First submitted
- 24 Aug 2017
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Claus CF, Turnbull JP, Sarcar BK, Griepp DW, Anton G, Lawless MH, Lucke H, Brannan GD, Ahmed R, Beggs A, Kado K, Jasinski JM, Bono P, Carr DA, Kelkar PS, Houseman CM, Richards BF, Heitkotter H, Tong D, Soo TM. The effect of low-dose ketorolac on minimally invasive transforaminal lumbar interbody fusions: final analysis of a randomized, double-blinded, placebo-controlled trial. J Neurosurg Spine. 2026 Sep 4:1-10. doi: 10.3171/2026.5.SPINE26228. Online ahead of print.
PubMed 42696765Claus CF, Lytle E, Tong D, Sigler D, Lago D, Bahoura M, Dosanjh A, Lawless M, Slavnic D, Kelkar P, Houseman C, Bono P, Richards B, Soo TM. The effect of ketorolac on posterior thoracolumbar spinal fusions: a prospective double-blinded randomised placebo-controlled trial protocol. BMJ Open. 2019 Jan 21;9(1):e025855. doi: 10.1136/bmjopen-2018-025855.
PubMed 30670528
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ketorolac on Posterior Thoracolumbar Spinal Fusions: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03278691
- Acronym / sponsor ID
- IRB # 1072359
- Conditions
- Thoracolumbar Spinal Fusions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Sep 2017 (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.
To determine is low-dose ketorolac use in the early post-operative period (within 48 hours) provides adequate analgesia without long term adverse effect on spinal fusion rates when compared to post-operative analgesia without the use of NSAIDs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: SalineDrug: Placebo Saline 1 ml IV Q6H |
| Intervention | Experimental | Drug: KetorolacKetorolac 15 mg (15mg/ml) IV Q6H |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 years of age
- Elective thoracolumbar posterior lumbar instrumented interbody fusion
- Minimally invasive spine surgery (MIS)
- 3 or fewer levels
- Bone Morphogenetic Protein (BMP) use in interbody fusion (1.05mg/level or less)
Key exclusion criteria (16 listed)
- Active tobacco smoker or history of tobacco smoking in the past 6 weeks
- Previous history of surgery at operative level(s)
- History of chronic inflammatory/rheumatological condition
- History of systemic steroid use in the past 3 months
- Auto/Workers' compensation patients
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 |
|---|---|---|
| Saline1 ml saline IV Q6H | Drug | Placebo |
| Ketorolac15 mg (15 mg/ml) IV Q6H | Drug | Intervention |
Primary outcome
Fusion Construct X-Ray
Time frame: 6 months postoperatively
Each fusion level will be evaluated individually and as part of the complete fusion construct. Fusion will be evaluated by blinded independent neuroradiologists using XR.
Fusion Construct X-Ray
Time frame: 12 months postoperatively
Each fusion level will be evaluated individually and as part of the complete fusion construct. Fusion will be evaluated by blinded independent neuroradiologists using XR.
Fusion Construct X-Ray
Time frame: 24 months postoperatively
Each fusion level will be evaluated individually and as part of the complete fusion construct. Fusion will be evaluated by blinded independent neuroradiologists using XR.
5 secondary outcomes
Visual Analogue Scale (VAS) for pain
Time frame: Every 8 hours x 48 hours postoperatively
Length of Stay (LOS)
Time frame: 12 months postoperatively
Morphine equivalent doses
Time frame: 12 months postoperatively
Complications/Adverse events
Time frame: 12 months postoperatively
Quality of life - long term
Time frame: 12 months and/or 24 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Derived from this study: PubMed 42696765Claus CF, Turnbull JP, Sarcar BK, Griepp DW, Anton G, Lawless MH, Lucke H, Brannan GD, Ahmed R, Beggs A, Kado K, Jasinski JM, Bono P, Carr DA, Kelkar PS, Houseman CM, Richards BF, Heitkotter H, Tong D, Soo TM. The effect of low-dose ketorolac on minimally invasive transforaminal lumbar interbody fusions: final analysis of a randomized, double-blinded, placebo-controlled trial. J Neurosurg Spine. 2026 Sep 4:1-10. doi: 10.3171/2026.5.SPINE26228. Online ahead of print.
- Derived from this study: PubMed 30670528Claus CF, Lytle E, Tong D, Sigler D, Lago D, Bahoura M, Dosanjh A, Lawless M, Slavnic D, Kelkar P, Houseman C, Bono P, Richards B, Soo TM. The effect of ketorolac on posterior thoracolumbar spinal fusions: a prospective double-blinded randomised placebo-controlled trial protocol. BMJ Open. 2019 Jan 21;9(1):e025855. doi: 10.1136/bmjopen-2018-025855.
- Individual participant dataSharing planned: No
Related trials for Thoracolumbar Spinal Fusions
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Retrospective Evaluation of Upper Instrumented Vertebrae (UIV) Screw Loosening Following Spine Surgery
Thoracolumbar Spinal Fusion
RecruitingObservational study
Clinical Outcome Measure at Stryker Spine
Degenerative Disc Disease, Degenerative Scoliosis
Not yet recruiting
TLIP Block Versus Retrolaminar Block on Quality of Recovery After Posterior Lumbar Spine Fusion Surgery
Postoperative Pain, Spinal Fusion Surgery
RecruitingEarly Phase 1
Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
Delirium, Pain, Back
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.
Chad Claus, DO contact
Doris Tong, MD study director
Michigan Spine and Brain Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saline and Ketorolac in people with Thoracolumbar Spinal Fusions, run by Henry Ford Health System at 1 site in United States.
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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 20 Apr 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doris Tong, MD ((248) 763-2380, doris.tong@michiganspineandbrainsurgeons.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion Construct X-Ray (time frame: 6 months postoperatively). The study lists 3 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 NCT03278691, which also lists 2 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 20 Apr 2023.