ACDF Using Structural Allograft vs. Tritanium C

Official title

Comparison of Clinical Outcomes Following ACDF With Instrumentation Using Structural Allograft vs. Tritanium C

Overview

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.

Interventions

• 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
• 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

• Time to the presence of fusion [Time frame: 3 months post-operatively]
• Time to the presence of fusion [Time frame: 6 months post-operatively]
• Time to the presence of fusion [Time frame: 12 months post-operatively]

Secondary outcome measures (5)

• Neck disability [Time frame: Baseline, 3, 6, and 12 months post-operatively]
• Neck and arm pain [Time frame: Baseline, 3, 6, and 12 months post-operatively]
• Incidence of sensory deficits [Time frame: Baseline, 3, 6, and 12 months post-operatively]
• Incidence of motor deficits [Time frame: Baseline, 3, 6, and 12 months post-operatively]
• Rate of Adverse Events [Time frame: Day of surgery, 3, 6 and 12 month post-operatively]

Eligibility criteria

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 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:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• Allegheny Health Network — Pittsburgh

Identifiers

NCT: NCT04388332 · Stryker IIT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗