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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04073563




Registration number
NCT04073563
Ethics application status
Date submitted
27/08/2019
Date registered
29/08/2019
Date last updated
1/10/2024

Titles & IDs
Public title
Transforaminal Lumbar Interbody Fusion (TLIF)
Scientific title
Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse™ Bone Graft With an Intervertebral Body Fusion Device and Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine
Secondary ID [1] 0 0
MDT17074SD1706
Universal Trial Number (UTN)
Trial acronym
TLIF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative Disease of the Lumbosacral Spine 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Infuse™ Bone Graft (Infuse™)
Treatment: Devices - Intervertebral body fusion device and Medtronic posterior Fixation Systems

Experimental: Group #1 - Investigational Infuse™ 2.1 mg/level with available local bone autograft and supplemented with cancellous allograft as needed

Experimental: Group #2 - Investigational Infuse™ 4.2 mg/level with available local bone autograft and supplemented with cancellous allograft as needed

Active comparator: Control - Local bone autograft and supplemented with cancellous allograft as needed.


Treatment: Devices: Infuse™ Bone Graft (Infuse™)
(Recombinant human bone morphogenetic protein-2 (rhBMP-2)/absorbable collagen sponge (ACS))

Treatment: Devices: Intervertebral body fusion device and Medtronic posterior Fixation Systems
Adaptix™Interbody System, Capstone™ Spinal System, Catalyft™ PL Interbody System
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall success at 24 months
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Fusion success at 24 months
Timepoint [2] 0 0
24 Months
Secondary outcome [1] 0 0
Time to fusion
Timepoint [1] 0 0
From surgery to 24 Months
Secondary outcome [2] 0 0
ODI success
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Leg pain success
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Back pain success
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Neurological success
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Serious Adverse Events
Timepoint [6] 0 0
up to 24 months
Secondary outcome [7] 0 0
Secondary Surgery
Timepoint [7] 0 0
up to 24 months

Eligibility
Key inclusion criteria
A subject must meet all of the following inclusion criteria to participate in this study:

* I.1. Has degenerative disease of the lumbosacral spine in one or two adjacent levels (L2 to S1) that results in radiculopathy secondary to nerve root compression, manifested by:

1. History of radiating leg or buttock pain, paresthesia, numbness or weakness, or
2. History of neurogenic claudication.
* I.2. Has a history of low back pain.
* I.3. Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including at least one of the following:

1. Instability up to and including Grade 2 spondylolisthesis/retrolisthesis based on the Meyerding classification (Meyerding, HW, 1932), or lateral listhesis demonstrated by coronal plane translation (slippage) of the superior (cranial) vertebral body lateral to the inferior (caudal) vertebral body less than or equal to 3mm, or
2. Stenosis, or narrowing, of the lumbar spinal canal and/or intervertebral foramen requiring significant decompression leading to segmental instability, or
3. Recurrent disc herniation
* I.4. Has preoperative Oswestry Disability Index score = 35.

Has to meet either inclusion criteria 5 or 6 to qualify for the study:

* I.5. Has preoperative back and leg pain scores of (back pain = 4 and leg pain = 1) based on the Preoperative Back and Leg Pain Questionnaire.
* I.6. Has preoperative back and leg pain scores of (back pain = 1 and leg pain = 4) based on the Preoperative Back and Leg Pain Questionnaire.
* I.7. Is at least 18 years of age and skeletally mature at the time of surgery.
* I.8. Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of six months.
* I.9. Is willing and able to comply with the study plan and able to understand and sign the subject Informed Consent Form.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A subject will be excluded from participating in this study for any of the following reasons:

* E.1 Prior surgical procedure at the involved or adjacent spinal levels (e.g. fusion, arthroplasty, and/or other non-fusion procedures). Prior discectomy and/or laminectomy at the target or adjacent levels is allowed.
* E.2 Significant lumbar instability defined as sagittal listhesis greater than Grade 2 at any involved level using the Meyerding Classification or lateral listhesis greater than 3 mm at any involved level.
* E.3 Planned use of an internal or external bone growth stimulator.
* E.4 Lumbar scoliosis >30 degrees.
* E.5 Patients who had a previous diagnosis of osteoporosis with a T-score of -2.5 or below in the last 12 months existing together with a prevalent fragility fracture. (If subject has a prevalent fragility fracture and a T-score hasn't been assessed in the last 12 months, a DEXA will need to be obtained.)
* E.6 Morbidly obese, as defined by a Body Mass Index (BMI) >40.
* E.7 Presence of active malignancy or prior history of malignancy (non-invasive basal cell carcinoma of the skin and non-invasive squamous cell carcinoma localized only to the skin is allowed).
* E.8 Overt or active bacterial infection, either local to surgical space or systemic.
* E.9 Has undergone administration of any type of corticosteroid, antineoplastic, immunostimulating, or immunosuppressive agents, or medications known to inhibit the healing of bone or soft tissue within 30 days prior to implantation of the assigned treatment.

* This includes patients = 65 years of age taking warfarin with documented diagnosed osteoporosis. All other patients taking warfarin should washout for at least 5 days prior to treatment
* Use of steroidal inhalers is allowed pre- and post-operatively
* Short-term steroidal use (e.g., Medrol Dosepak) is allowed pre and post-operatively. For this clinical study, short-term use is defined as = two weeks. Use of steroids for longer than two weeks post-operatively through the 24-month follow-up visit is prohibited.
* E.10 Co-morbidities, which in the investigator's opinion, precludes the subject from being a surgical candidate.
* E.11 Autoimmune disease, which in the investigator's opinion, is known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves' disease, Hashimoto's thyroiditis).
* E.12 Any endocrine or metabolic disorder, which in the investigator's opinion, is known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
* E.13 Known exposure to any recombinant proteins used for bone formation (e.g., Infuse™ Bone Graft, OP-1 Putty, OP-1 Implant, AUGMENT Bone Graft, GEM21S, i-FACTOR Peptide Enhanced Bone Graft, or PepGen P-15 Synthetic Bone Graft).
* E.14 Known hypersensitivity or allergy to any components of the study treatments including, but not limited to bone morphogenetic proteins (BMPs); injectable collagen; protein pharmaceuticals (e.g.,monoclonal antibodies or gamma globulins); bovine collagen products; and/or instrumentation materials (e.g., titanium, titanium alloy, cobalt chrome, cobalt chrome alloy, or PEEK).
* E.15 History of any allergy resulting in anaphylaxis.
* E.16 Is a prisoner.
* E.17 Is mentally incompetent. If questionable, obtain psychiatric consult.
* E.18 Treatment with an investigational therapy (drug, device, and/or biologic) targeting spinal conditions within 3 months prior to implantation surgery, treatment with any other investigational therapies within 30 days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment.
* E.19 Pregnant or nursing. Females of child-bearing potential must agree not to become pregnant for 24 months following surgery.
* E.20 A documented diagnosis of substance use disorder as defined by the DSM-5.22 (Nicotine use is allowed.)
* E.21 Pursuing worker's compensation or active litigation for spinal fusion procedure.
* E.22 Any condition, which in the investigator's opinion, would interfere with the subject's ability to comply with study instructions, which might confound data interpretation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2028
Actual
Sample size
Target
1017
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
West Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
China
State/province [23] 0 0
Beijing
Country [24] 0 0
China
State/province [24] 0 0
Chengdu
Country [25] 0 0
China
State/province [25] 0 0
Chongqing

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Spinal and Biologics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lindsey Mitchell, MS
Address 0 0
Country 0 0
Phone 0 0
763-505-0264
Fax 0 0
Email 0 0
Lindsey.Mitchell@medtronic.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04073563