Clinical trial NCT04388332: ACDF Using Structural Allograft Vs. Tritanium C
Official title: Comparison of Clinical Outcomes Following ACDF with Instrumentation Using Structural Allograft Vs. Tritanium C
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Degenerative Disc Disease
Keywords: Tritanium C
Structural Bone Graft
Anterior Cervical Discectomy and Fusion
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
Collaborators: name: Stryker Spine
First posted: 2020-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: retrospective/prospective observational, two arm study - 40 patients in retrospective cohort (data collection from previous procedure) compared to 20 patients in Prospective cohort
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Retrospective Cohort: A maximum of 200 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 at AHN in the past will retrospectively be screened for inclusion into a pool of potential candidates for the retrospective cohort. Patients will be included in this preliminary pool if the following information are available: age (at surgery), sex, body mass index (at surgery), no smoking at baseline, number of levels operated on, which specific levels were operated on, standard of care clinic follow-up at 6 and 12 months (3 month visit not required) and imaging that can be used to assess fusion at baseline, 6 and 12 months (3 month imaging not required). If available, NDI and VAS, questionnaires completed during baseline and post-op visits will be collected.

This pool of retrospective cohort candidates will be used to match the patients in the prospective cohort to patients treated with structural allograft using a 1:2 ratio. Thus, 40 patients will ultimately be included in the retrospective cohort.

Eligibility 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 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 these patients will be followed for a maximum of one year (up to 08/14/2024 for a patient enrolled at the end of this inclusion period)

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
18. Subject is missing 6 and/or 12 month clinical or radiographic follow-up (Retrospective study)

Primary outcomes:
measure: Time to the presence of fusion
timeFrame: 3 months post-operatively
measure: Time to the presence of fusion
timeFrame: 6 months post-operatively
measure: Time to the presence of fusion
timeFrame: 12 months post-operatively
Secondary outcomes:
measure: Neck disability
timeFrame: Baseline, 3, 6, and 12 months post-operatively
measure: Neck and arm pain
timeFrame: Baseline, 3, 6, and 12 months post-operatively
measure: Incidence of sensory deficits
timeFrame: Baseline, 3, 6, and 12 months post-operatively
measure: Incidence of motor deficits
timeFrame: Baseline, 3, 6, and 12 months post-operatively
measure: Rate of Adverse Events
timeFrame: Day of surgery, 3, 6 and 12 month post-operatively
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
Study officials:
affiliation: Allegheny Health Network
name: Nestor Tomycz, MD
role: PRINCIPAL_INVESTIGATOR
References: