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New treatment option for Degenerative Disc Disease
Official title ACDF Using Structural Allograft vs. Tritanium C
ClinicalTrials.gov ID: NCT04388332
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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)
You likely can't join if
- 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...
- Use of bone growth stimulator
- Subject has prior fusion at the levels to be treated
See the full eligibility 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)
- people that will prospectively undergo one or two level anterior cervical discectomy and fusion with Tritanium C (Prospective study)
- people that underwent one or two level anterior cervical discectomy and fusion with either standard of care structural allograft bone at any AHN facility from 01/01/2016 to 08/14/2023 (Retrospective study) Note that...
- 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...
- 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
- people with current active psychiatric diagnosis or a personality disorder likely to interfere with the study
- people 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
- Subject is missing 6 and/or 12 month clinical or radiographic follow-up (Retrospective study)
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.