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KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar Interbody Fusion (STRUCTURE)

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ClinicalTrials.gov Identifier: NCT04294004
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : February 12, 2021
Sponsor:
Collaborators:
Factory CRO
Kuros BioSciences B.V.
Information provided by (Responsible Party):
Kuros Biosurgery AG

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of KUR-113 Bone Graft (TGplPTH1-34 in fibrin) compared to local autograft for the treatment of Degenerative Disk Disease (DDD).

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Spinal Fusion Combination Product: TGplPTH1-34 in fibrin Other: Autologous Bone Graft Phase 2

Detailed Description:

Degenerative disc disease (DDD) is a common disorder of the lumbar spine. Clinically, DDD causes discogenic back pain and may cause related radicular, neuropathic, claudicatory, and referred pain.

This is a prospective, randomized, controlled, single-blind, dose-finding, multi-center study which intends to demonstrate the safety and efficacy of KUR-113 Bone Graft (TGplPTH1-34 in fibrin) versus local autograft. The study will enroll 50 patients with Degenerative Disk Disease (DDD) requiring single-level interbody fusion along with posterolateral fusion (PLF) with posterior fixation who meet eligibility criteria and agree to participate in the study. Safety and efficacy of KUR-113 Bone Graft will be evaluated by analyzing all clinical as well as radiological endpoints and adverse events. This phase 2a study is not powered to detect non-inferiority. All patients will undergo clinical and radiological assessments at initial hospital discharge (on average 3 days post-surgery), 6 weeks, 3, 6, 12 and 24 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Due to the different technical procedures between the control and the intervention arms (KUR-113 Bone Graft versus local autograft), investigators cannot be blinded to the treatment. However, all patients will remain blinded for the duration of their participation in the study.
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Single-blind, Dose-finding, Multi-center, Parallel Group Study of Safety/Efficacy of KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar Interbody Fusion
Actual Study Start Date : August 27, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: KUR-113, Stage 1
During stage 1, subjects randomized to this arm will receive TGplPTH1-34 in fibrin (0.4mg/ml) that will be applied within and around a polyetheretherketone (PEEK) intervertebral cage. The maximum dose that will be applied is 4 mg of TGplPTH1-34 in 10mL KUR-113 Bone Graft.
Combination Product: TGplPTH1-34 in fibrin
TGplPTH1-34 within a fibrin matrix applied within and around a polyetheretherketone (PEEK) intervertebral cage
Other Name: KUR-113

Active Comparator: Autologous Bone Graft
During stage 1 of the study, subjects randomized to this arm will receive local autologous bone graft. In the event of insufficient local autograft, Iliac crest bone graft may be used to supplement.
Other: Autologous Bone Graft
Local autograft collected from decompression which may be supplemented with iliac crest bone graft (ICBG) if local autograft is insufficient.

Experimental: KUR-113, Stage 2
During stage 2, subjects will receive TGplPTH1-34 in fibrin that will be applied within and around a PEEK intervertebral cage at a concentration of either 0.2mg/ml or 0.7mg/ml. The concentration received will be selected by the DSMB based on the results of stage 1. The maximum dose that will be applied is either 2 mg or 7 mg of TGplPTH1-34 in 10mL KUR-113 Bone Graft.
Combination Product: TGplPTH1-34 in fibrin
TGplPTH1-34 within a fibrin matrix applied within and around a polyetheretherketone (PEEK) intervertebral cage
Other Name: KUR-113




Primary Outcome Measures :
  1. Radiographic interbody fusion [ Time Frame: Month 12 post-surgery ]
    Evidence of bridging trabeculae or continuous bony connection between superior and inferior vertebral body on CT-scan as determined by an independent radiology expert panel (IREP).


Secondary Outcome Measures :
  1. Composite Endpoint [ Time Frame: Month 6 and Month 12 post-surgery ]
    Radiographic interbody fusion using CT-scans, functional outcome (decrease of 15 points or more on Oswestry Disability Index (ODI)) and no post-surgical intervention to aid fusion or replace any of the spinal implants.

  2. Radiographic interbody fusion [ Time Frame: Month 6 post-surgery ]
    Determined by IREP using CT-scans

  3. Radiographic posterolateral fusion [ Time Frame: Month 6 and Month 12 post-surgery ]
    Determined by IREP using CT-scans

  4. ODI [ Time Frame: Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery ]
    Change from baseline

  5. Leg Pain [ Time Frame: Initial discharge from hospital (on average 3 days post-surgery), Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery ]
    Change from baseline using Visual Analogue Scale (VAS). VAS is scored from 0 to 100 with higher numbers being a worse outcome than a lower number.

  6. Back Pain [ Time Frame: Initial discharge from hospital (on average 3 days post-surgery), Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery ]
    Change from baseline using Visual Analogue Scale (VAS). VAS is scored from 0 to 100 with higher numbers being a worse outcome than a lower number.

  7. Number of Secondary Interventions [ Time Frame: Up to Month 24 post-surgery ]
    Revisions, re-operations, removals, supplemental fixations, or any other procedure that adjusts or in any way removes part of the original implant configuration with or without replacement of the components



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent by the patient.
  2. Male or female patient ≥ 25 up to and including 75 years old. Females of childbearing potential with a negative urine pregnancy test at Screening. Females of childbearing potential must agree to use acceptable contraception for at least 12 months after surgery and investigational product placement.
  3. Patients with degenerative disc disease with up to grade 1 spondylolisthesis and with leg pain requiring up to 3 levels of laminectomy/decompression and a single-level fusion (L2 - S1). DDD is defined by the presence of one or more of the following:

    1. instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
    2. osteophyte formation of facet joints or vertebral endplates,
    3. decreased disc height by > 2 mm, but dependent upon the spinal level,
    4. scarring/thickening of ligamentum flavum, annulus fibrosis or facet joint capsule,
    5. disc degeneration and/or herniation,
    6. facet degeneration,
    7. vacuum phenomenon.
  4. Patients with an Oswestry Disability Index (ODI) score ≥ 35.
  5. Patients with a Visual Analogue Scale (VAS) leg score ≥ 40.
  6. Failed conservative treatment (physical therapy, bed rest, medications, spinal injections or transcutaneous electrical nerve stimulation) for a period of 6 months prior to study enrollment.
  7. Patients willing to undergo PK sampling.

Exclusion Criteria:

  1. Patients with open epiphyseal plates.
  2. Patient requiring emergency spinal decompression or spinal fusion.
  3. Patients requiring multilevel fusion or expected to need secondary intervention within one year following surgery.
  4. Any prior fusion or attempted fusion at an adjacent level.
  5. Any prior fusion or attempted fusion at the index level.
  6. Pregnant or breast-feeding women.
  7. Known or suspected allergies to any of the components of KUR-113 Bone Graft (e.g.

    hypersensitivity to aprotinin).

  8. Any prior use of teriparatide or abaloparatide or graft material containing PTH1-34.
  9. Patients with hypercalcemic disorders (e.g., primary hyperparathyroidism).
  10. Patients with Paget's Disease or unexplained high levels of alkaline phosphatase.
  11. Prior radiation therapy involving bone.
  12. Medical history or radiographic evidence of a metabolic bone disorder (e.g. Paget's Disease) or other condition that would negatively impact the healing process.
  13. Any medical condition requiring radiotherapy or immunosuppression.
  14. History of thyroid autoimmune disease (Hashimoto's thyroiditis, Graves' disease) or hyperthyroidism.
  15. Patients on chronic systemic steroids (i.e. > 14 consecutive days) within 6 months prior to Screening Visit.
  16. Osteopenia (T score < -1.0) or osteoporosis of the spine (T score < -2.5).
  17. DDD related to benign or malignant tumor.
  18. History or presence of active malignancy.
  19. Hereditary disorders predisposing to osteosarcoma.
  20. Patients with invasive skin cancer.
  21. Evidence of local or systemic infection.
  22. Patients with known active COVID-19 disease.
  23. Current smokers.
  24. Type 1 diabetes (regardless of HbA1c) or Type 2 diabetes with a documented HbA1c > 7.0.
  25. Any acute or chronic concurrent medical conditions that in the Investigator's opinion are a contraindication to the procedure and study participation.
  26. Participation in another investigational study within 30 days prior to surgery for investigational devices, or within the last three months for investigational drugs. (Note: trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).
  27. Known substance abuse, psychiatric disorder or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements.
  28. Involved in active litigation relating to his/her spinal condition or workers compensation claimants.
  29. BMI greater than 40.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04294004


Contacts
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Contact: Marion Bertrand 31 (0)30 7400455 marion.bertrand@kurosbio.com
Contact: Linda Custer (410) 215-0540 linda.custer@avaniaclinical.com

Locations
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United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093-0863
United States, Colorado
Justin Parker Neurological Institute Recruiting
Boulder, Colorado, United States, 80303
United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
United States, Illinois
Northwestern University-Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana Spine Group Recruiting
Carmel, Indiana, United States, 46032
United States, Louisiana
Spine Institute of Louisiana Recruiting
Shreveport, Louisiana, United States, 71101
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Kuros Biosurgery AG
Factory CRO
Kuros BioSciences B.V.
Investigators
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Principal Investigator: John Chi, MD Brigham and Women's Hospital
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Responsible Party: Kuros Biosurgery AG
ClinicalTrials.gov Identifier: NCT04294004    
Other Study ID Numbers: KUR-113/01
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kuros Biosurgery AG:
Spinal Fusion
Posterolateral Fusion
MagnetOs
Fibrin-PTH (KUR-113)
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases