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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06154005




Registration number
NCT06154005
Ethics application status
Date submitted
15/11/2023
Date registered
1/12/2023
Date last updated
19/09/2024

Titles & IDs
Public title
[Trial of device that is not approved or cleared by the U.S. FDA]
Scientific title
[Trial of device that is not approved or cleared by the U.S. FDA]
Secondary ID [1] 0 0
OASP.T1.01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative Disc Disease 0 0
Degenerative Spondylolisthesis 0 0
Spinal Stenosis 0 0
Spine Disease 0 0
Lumbar Radiculopathy 0 0
Lumbar Spinal Stenosis 0 0
Lumbar Disc Herniation 0 0
Lumbar Disc Disease 0 0
Lumbar Spine Degeneration 0 0
Lumbar Spondylolisthesis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - OsteoAdapt SP
Other interventions - Local Autograft

Experimental: Low Dose OsteoAdapt SP (0.8 mg/cc AMP2/OsteoAdapt SP) - Participants will receive a Transforaminal Lumbar Interbody Fusion with OsteoAdapt SP "Low Dose (0.8mg/cc AMP2/OsteoAdapt SP)" inside the interbody fusion cage with the availability of having local autograft placed anterior/lateral to the cage within the disc space.

Experimental: High Dose OsteoAdapt SP (2.0 mg/cc AMP2/OsteoAdapt SP) - Participants will receive a Transforaminal Lumbar Interbody Fusion with OsteoAdapt SP "Low Dose (2.0 mg/cc AMP2/OsteoAdapt SP)" inside the interbody fusion cage with the availability of having local autograft placed anterior/lateral to the cage within the disc space.

Active Comparator: Control (Standard of Care - Autograft/Mineralized Allograft) - Patients will follow standard of care Transforaminal Lumbar Interbody Fusion in which local autograft will be placed inside the interbody fusion cage with the availability of mineralized, frozen, banked, allograft to be placed anterior/lateral to the cage.


Treatment: Devices: OsteoAdapt SP
OsteoAdapt SP is a combination of AMP2 protein bound to an osteoconductive carrier matrix, ReBOSSIS-J. OsteoAdapt SP is a combination of AMP2 protein bound to an osteoconductive carrier matrix, ReBOSSIS-J.
AMP2 is a recombinant variant of a naturally occurring human protein, rhBMP2, that has been modified to allow very tight binding to ß-TCP and similar ceramics. AMP2 is osteoinductive, meaning that the protein stimulates new bone formation at the site of implantation through the same intracellular signaling process as rhBMP2.
ReBOSSIS-J is a synthetic, resorbable bone void filler. ReBOSSIS-J is flexible and can easily fill defects of different sizes using appropriate amounts of the device.
The combination product, OsteoAdapt SP, is hydrated at the time of surgery with saline and placed into the interbody fusion cage.

Other interventions: Local Autograft
For control arm, local autograft will be utilized inside the interbody cage.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Subjects requiring Secondary Surgical Interventions within 24 months post-op.
Timepoint [1] 0 0
up to 24 months post op
Primary outcome [2] 0 0
Neurological Status assessed via Motor, Sensory, and Reflex physical exams with outcome measures of "normal", "abnormal" or "unknown". Success defined as maintenance or improvement compared to baseline assessment.
Timepoint [2] 0 0
Baseline compared to 24 months post op
Primary outcome [3] 0 0
Oswestry Disability Index - Measured on a scale of 0-100 points, 0 being least physically impaired for day to day activities and 100 being extremely difficult or impossible to perform day to day activities.
Timepoint [3] 0 0
Baseline compared to 24 months post op
Primary outcome [4] 0 0
Numeric Pain Rating Scale - Pain scale measured on a scale from 0 to 10 (0=no pain; 10 = pain as bad as it can be) compared at 24 months post op to baseline assessment.
Timepoint [4] 0 0
Baseline compared to 24 months post op
Primary outcome [5] 0 0
Radiographic Fusion Assessment - assessed by CT at 12- and 24-months post op as bridging bone from endplate to endplate.
Timepoint [5] 0 0
Assessed at 24 months post op
Secondary outcome [1] 0 0
PROMIS short form, validated, quality of life questionnaire to assess subjects overall mental and general health through a series of 12 questions regarding depression, anxiety, and general health.
Timepoint [1] 0 0
24 months post op
Secondary outcome [2] 0 0
Assessment for Immunogenic effects (e.g., anti BMP-2) caused by rhBMP2 antibodies as detected in subject's blood serum through antibody assays.
Timepoint [2] 0 0
Pre-op to 24 months (if applicable)
Secondary outcome [3] 0 0
Disc height assessment at the operative level as determined by plain Xray radiographs at each study timepoint.
Timepoint [3] 0 0
Pre-op, 6 weeks, 3 months, 6 months, 12 months, 24 months

Eligibility
Key inclusion criteria
- Male or Female age 18-80 (inclusive) at time of signing informed consent and
skeletally mature (as determined by physician's assessment of AP lumbar Xray utilizing
the Risser Classification method of the iliac crest growth plates) (See addendum 1 for
a definitive reference on skeletal age);

- Subject is planning to undergo a unilateral, single-level, single interbody cage, TLIF
procedure (from L2-S1 with posterior supplemental fixation) with a primary diagnosis
of symptomatic lumbar degeneration including back and/or radicular pain with or
without foraminal or recess stenosis confirmed by patient history, physical
examinations, and radiographic imaging (xray, CT, MRI) with no more than Grade 2
Spondylolisthesis with one or more of the following factors:

1. Instability as defined by >/-3mm translation or >/-5° angulation;

2. Osteophyte formation of facet joints or vertebral endplates;

3. Decreased disc height, on average by >2mm, but dependent upon the spinal level;

4. Scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint
capsule;

5. Herniated nucleus pulposus; facet joint degeneration/changes; and/or

6. Vacuum phenomenon.

- Preoperative ODI score =40 at pre-op/baseline;

- Preoperative back and/or leg pain score of =4 (out of 10);

- Failed =6 months non-operative/conservative treatment (e.g., physical therapy,
bracing, traction, medication, TENS, and/or spinal injections;

- Is willing and able to be present for routine follow up visits, comply with
postoperative management program, and is able to understand and sign the informed
consent form.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Patient requires spinal fusion surgical procedure (TLIF) at more than one level
(non-fusion surgery at the non-index levels, including discectomy and/or single level
foraminotomy or laminectomy, is allowed)

- Prior spinal fusion surgical procedure at the involved or adjacent spinal levels, or
non-fusion stabilizing surgeries, e.g., interlaminar devices, dynamic stabilization,
or disc replacements. (Prior non-fusion surgery at the target levels, including
discectomy and/or single level foraminotomy or laminectomy, is allowed.)

- Greater than Grade 2 Spondylolisthesis;

- Planned use of an internal or external bone growth stimulator;

- Osteoporosis to a degree that spinal instrumentation is contraindicated or a history
of a traumatic vertebral fracture. All patients complete SCORE/MORE to assess the need
for DEXA scan. If DEXA is required, patients with a T score </- 2.5 will be excluded.
A prior DEXA can be used if performed within 9 months pre-op;

- Morbidly obese, as defined by a Body Mass Index (BMI) >40;

- Overt or active bacterial infection, either local or systemic;

- The subject uses, or has used within 30 days of surgery, tobacco or nicotine or is
prescribed steroids such as cortisone; (subjects will undergo a nicotine test during
screening procedures utilizing a standard commercial cotinine urine dip test; Example:
Easy@Home Nicotine Cotinine Urine Panel Dip Test Strips Kit- Sensitive
(healthcare-manager.com)

- Comorbidities precluding subject from being a surgical candidate;

- Systemic disease including Lupus disease, Reiter's disease, Rheumatoid disease, AIDS,
HIV, hepatitis, or autoimmune disease that requires immunosuppressive therapy,
including biologics, for systemic inflammation.

- History of malignancy, radiotherapy, or chemotherapy for any malignancy within the
last 5 years. History of malignancy may include multiple exostoses syndrome ((also
known as multiple osteochondromas syndrome), an inherited condition associated with
bumps of cartilage on the bones, has been associated with an increased risk of
chondrosarcoma); individuals who have undergone any transplant surgery and are on
immunosuppressant therapy.

- Has history of any endocrine or metabolic disorder known to affect osteogenesis (e.g.:
Paget's disease, renal osteodystrophy, Ehler-Danlos syndrome, or osteogenesis
imperfecta);

- Insulin dependent diabetes;

- History of exposure to any recombinant proteins or peptides used for bone formation
(i.e., Infuse Bone Graft, AUGMENT Bone Graft, GEM21S, i-FACTOR Peptide Enhanced Bone
Graft, or PepGen P-15 Synthetic Bone Graft);

- Hypersensitivity or allergy to any components of the study treatments including, but
not limited to, bone morphogenetic proteins (BMPs); tricalcium phosphate (TCP); PLGA
polymer; and/or instrumentation materials (titanium, titanium alloy, PEEK).

- History of any allergy resulting in anaphylaxis;

- Is a prisoner;

- Is mentally incompetent. If questionable, obtain psychiatric consult;

- History of substance abuse (substance abuse defined by DSM-5 (The Diagnostic and
Statistical Manual of Mental Disorders) code. Criteria for substance abuse defined in
Addendum 2.

- Involved in litigation for spine injury or worker's compensation case;

- Treatment with an investigational therapy (drug, device, and/or biologic) within 120
days prior to implantation surgery, or such treatment is planned during the 24-month
period following implantation of the study treatment; prior or planned use of rhBMP-2.

- Pregnant (or interested in becoming pregnant in the next 24 months) or nursing.

- Any condition that would interfere with the subject's ability to comply with study
instructions or prohibit MRI/CT/Radiographic assessments that might confound the
interpretation of the study or put the subject at risk.

- Patients with any positive pregnancy test. Tests will be administered at the surgical
center prior to surgery.

- Patient currently taking any drug known to interfere with bone/soft tissue healing.
See "Medication Protocol" section of the Investigator's Brochure.

- Any other condition or prior therapy that in the opinion of the Investigator would
make the volunteer unsuitable for this study, including inability to cooperate fully
with the requirements of the study protocol or likelihood of noncompliance with any
study. requirements.

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
Phase 1/Phase 2
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
1/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
International Spine Centre - Norwood
Recruitment postcode(s) [1] 0 0
5067 - Norwood

Funding & Sponsors
Primary sponsor type
Name
[Redacted]
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
https://clinicaltrials.gov/study/NCT06154005
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Luis Alvarez, PhD
Address 0 0
Founder
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Danette Newton, MS
Address 0 0
Country 0 0
Phone 0 0
+1 240 415 9776
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06154005