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ACDF Using Structural Allograft vs. Tritanium C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04388332
Recruitment Status : Not yet recruiting
First Posted : May 14, 2020
Last Update Posted : June 17, 2020
Sponsor:
Collaborator:
Stryker Spine
Information provided by (Responsible Party):
Nestor Tomycz, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Brief Summary:
This is an observational, descriptive, prospective and retrospective data collection study. The purpose of this study is to observe radiographic outcomes of patients who will undergo anterior cervical discectomy and fusion (ACDF) utilizing Tritanium C (Stryker Spine). The rate of fusion success and adverse events will be compared retrospectively to patients who underwent instrumented ACDF utilizing structural allograft bone with plates.

Condition or disease Intervention/treatment
Degenerative Disc Disease Procedure: Structural allograft Device: Tritanium C

Detailed Description:
Retrospective subjects will consist of 20 patients that received one or two level ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and /or corticocancellous bone chips. These subjects will be retrospectively reviewed for radiographic outcomes at 3, 6 and 12 months postoperatively, as well as adverse events and sensory and motor outcomes. If available, NDI and VAS questionnaires completed during baseline and post-op visits will be collected. Prospective subjects will consist of 20 patients who are receiving Tritanium C as standard of care. These subjects will be asked to complete NDI and VAS questionnaires at baseline and post-op visits. Radiographic outcomes, adverse events, sensory and motor neurological outcomes, as determined per standard of care will be collected at those same time points. The total number of subjects is N=40.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Comparison of Clinical Outcomes Following ACDF With Instrumentation Using Structural Allograft vs. Tritanium C
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Retrospective
20 patients that received one or two level ACDF structural allograft with plates with autograft and /or allograft comprised of cancellous and/or corticocancellous bone chips.
Procedure: Structural allograft
Subjects that have received ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and/or corticocancellous bone chips

Prospective
20 patients who are receiving Tritanium C as standard of care.
Device: Tritanium C
Subjects will receive the Tritanium C anterior cervical cage which is intended to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft




Primary Outcome Measures :
  1. Time to the presence of fusion [ Time Frame: 3 months post-operatively ]
    Antero-posterior and lateral plain radiographs

  2. Time to the presence of fusion [ Time Frame: 6 months post-operatively ]
    Antero-posterior and lateral plain radiographs

  3. Time to the presence of fusion [ Time Frame: 12 months post-operatively ]
    Antero-posterior and lateral plain radiographs


Secondary Outcome Measures :
  1. Neck disability [ Time Frame: Baseline, 3, 6, and 12 months post-operatively ]
    Neck Disability Index (NDI): Subjects will designate a statement that best describes their level of disability for each section of the survey. Statements are then ranked from 0-5, where 0 is a better outcome and 5 is a worse outcome. All rankings are totaled for a final score.

  2. Neck and arm pain [ Time Frame: Baseline, 3, 6, and 12 months post-operatively ]
    Visual Analog Scale (VAS) for neck and arm pain: Subjects will designate a score to represent their pain from 0 to 10. 0 is indicative of no pain and 10 is indicative of the worst possible pain.

  3. Incidence of sensory deficits [ Time Frame: Baseline, 3, 6, and 12 months post-operatively ]
    Yes or no response to: Sensory deficit at the surgical level, sensory deficit at an adjacent level to the surgical level, sensory deficit at a different level to the surgical level, any sensory deficit during follow-up

  4. Incidence of motor deficits [ Time Frame: Baseline, 3, 6, and 12 months post-operatively ]
    Yes or no response to: Motor deficit at the surgical level, motor deficit at an adjacent level to the surgical level, motor deficit at a different level to the surgical level, any motor deficit

  5. Rate of Adverse Events [ Time Frame: Day of surgery, 3, 6 and 12 month post-operatively ]
    Adverse Event assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population sample will be selected from Allegheny General Hospital.
Criteria

Inclusion Criteria:

  1. Males or females ≥18 years of age, ≤ 80 years of age
  2. Subject is skeletally mature
  3. Subject is diagnosed with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 -T1 disc
  4. Subject has received six weeks of non-operative therapy i.e. injections, physical therapy, oral steroids
  5. Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent (Prospective study)
  6. Subjects that will prospectively undergo one or two level anterior cervical discectomy and fusion with Tritanium C (Prospective study)
  7. Subjects that have previously undergone one or two level anterior cervical discectomy and fusion with either standard of care structural allograft bone (Retrospective study)

Exclusion Criteria:

Patients may not be enrolled in the study if any of the following exclusion criteria are present:

  1. Presence of an infection systemic or local
  2. Presence of marked local inflammation
  3. Subject has any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, primary or metastatic tumors involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis
  4. Use of bone growth stimulator
  5. Subject has prior fusion at the levels to be treated
  6. Subject has any neuromuscular deficit
  7. Subject has any condition of senility, mental illness, or substance abuse
  8. Subject has any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery in the judgement of the PI
  9. Subject has rapid joint disease, bone absorption, osteopenia, osteomalacia, and/or osteoporosis. Subject is pregnant or plans to become pregnant during the course of the study.
  10. BMI≥40 kg/m2
  11. Subject uses chronic corticosteroids
  12. Subjects with current active psychiatric diagnosis or a personality disorder likely to interfere with the study
  13. Subjects who smoke and do not plan to quit
  14. Mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care
  15. Subject has any open wounds
  16. Subject has inadequate tissue coverage over the operative site
  17. Subject may be sensitive to titanium materials

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): NCT04388332


Contacts
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Contact: Nestor Tomycz, MD 412-359-6200 nestor.tomycz@ahn.org
Contact: Alexander Yu, MD 412-359-6200 alexander.yu@ahn.org

Locations
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United States, Pennsylvania
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Contact: Anna M Polaski, PhD    412-359-4604    anna.polaski@ahn.org   
Principal Investigator: Nestor Tomycz, MD         
Sub-Investigator: Alexander Yu, MD         
Sub-Investigator: Gary Schmidt, MD         
Sponsors and Collaborators
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Stryker Spine
Investigators
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Principal Investigator: Nestor Tomycz, MD Allegheny Health Network
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Responsible Party: Nestor Tomycz, Assistant Professor, Department of Neurosurgery, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
ClinicalTrials.gov Identifier: NCT04388332    
Other Study ID Numbers: Stryker IIT
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Nestor Tomycz, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute):
Tritanium C
Structural Bone Graft
Anterior Cervical Discectomy and Fusion
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases