- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04388332
ACDF Using Structural Allograft vs. Tritanium C
February 7, 2023 updated by: Nestor Tomycz, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Comparison of Clinical Outcomes Following ACDF With Instrumentation Using Structural Allograft vs. Tritanium C
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexander Yu, MD
- Phone Number: 412-359-6200
- Email: alexander.yu@ahn.org
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15212
- Recruiting
- Allegheny Health Network
-
Contact:
- Laurie M Dennis, RN, BS
- Phone Number: 412-330-6152
- Email: laurie.dennis@ahn.org
-
Sub-Investigator:
- Gary Schmidt, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study population sample will be selected from Allegheny General Hospital.
Description
Inclusion Criteria:
- Males or females ≥18 years of age, ≤ 80 years of age
- Subject is skeletally mature
- Subject is diagnosed with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 -T1 disc
- Subject has received six weeks of non-operative therapy i.e. injections, physical therapy, oral steroids
- Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent (Prospective study)
- Subjects that will prospectively undergo one or two level anterior cervical discectomy and fusion with Tritanium C (Prospective study)
- 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:
- Presence of an infection systemic or local
- Presence of marked local inflammation
- 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
- Use of bone growth stimulator
- Subject has prior fusion at the levels to be treated
- Subject has any neuromuscular deficit
- Subject has any condition of senility, mental illness, or substance abuse
- Subject has any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery in the judgement of the PI
- 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.
- BMI≥40 kg/m2
- Subject uses chronic corticosteroids
- Subjects with current active psychiatric diagnosis or a personality disorder likely to interfere with the study
- Subjects who smoke and do not plan to quit
- Mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care
- Subject has any open wounds
- Subject has inadequate tissue coverage over the operative site
- Subject may be sensitive to titanium materials
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to the presence of fusion
Time Frame: 3 months post-operatively
|
Antero-posterior and lateral plain radiographs
|
3 months post-operatively
|
Time to the presence of fusion
Time Frame: 6 months post-operatively
|
Antero-posterior and lateral plain radiographs
|
6 months post-operatively
|
Time to the presence of fusion
Time Frame: 12 months post-operatively
|
Antero-posterior and lateral plain radiographs
|
12 months post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 3, 6, and 12 months post-operatively
|
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.
|
Baseline, 3, 6, and 12 months post-operatively
|
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
|
Baseline, 3, 6, and 12 months post-operatively
|
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
|
Baseline, 3, 6, and 12 months post-operatively
|
Rate of Adverse Events
Time Frame: Day of surgery, 3, 6 and 12 month post-operatively
|
Adverse Event assessment
|
Day of surgery, 3, 6 and 12 month post-operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nestor Tomycz, MD, Allegheny Health Network
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 20, 2020
Primary Completion (ANTICIPATED)
December 1, 2026
Study Completion (ANTICIPATED)
December 1, 2026
Study Registration Dates
First Submitted
April 2, 2020
First Submitted That Met QC Criteria
May 13, 2020
First Posted (ACTUAL)
May 14, 2020
Study Record Updates
Last Update Posted (ESTIMATE)
February 9, 2023
Last Update Submitted That Met QC Criteria
February 7, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Stryker IIT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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