ACDF Using Structural Allograft vs. Tritanium C

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04388332
• Other study ID #: Stryker IIT
• Status: Recruiting
• Start date: August 20, 2020
• Est. completion date: December 2026

Study information

• Verified date: February 2023
• Source: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Contact: Nestor Tomycz, MD
• Phone: 412-359-6200
• Email: nestor.tomycz[@]ahn.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

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

Locations

Country	Name	City	State
United States	Allegheny Health Network	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	Stryker Spine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the presence of fusion	Antero-posterior and lateral plain radiographs	3 months post-operatively
Primary	Time to the presence of fusion	Antero-posterior and lateral plain radiographs	6 months post-operatively
Primary	Time to the presence of fusion	Antero-posterior and lateral plain radiographs	12 months post-operatively
Secondary	Neck disability	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
Secondary	Neck and arm pain	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
Secondary	Incidence of sensory deficits	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
Secondary	Incidence of motor deficits	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
Secondary	Rate of Adverse Events	Adverse Event assessment	Day of surgery, 3, 6 and 12 month post-operatively