Prospective Study of Fusion Rates Using Spira-C Device for Anterior Cervical Discectomy and Fusion Surgery

A Prospective Clinical Pilot Study Of Fusion Rates Using Spira™-C Titanium 3-D Printed Interbody Device For Anterior Cervical Discectomy And Fusion

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03786432

Acronym

ACDF

Enrollment

Registered

2018-12-26

Start date

2019-01-10

Completion date

2022-06-30

Last updated

2023-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Disc Disease, Cervical Radiculopathy

Brief summary

The objective of this study is to perform a prospective, single-arm clinical evaluation utilizing the Spira™-C 3-D printed titanium interbody device for treatment of degenerative disc disease and spinal stenosis of the cervical spine to evaluate fusion status and patient reported outcomes. The primary objective is fusion status or bony healing within the device. Patient reported outcomes, i.e. pain, function, and quality of life will also be measured postoperatively.

Detailed description

This is a post-market, single-arm, prospective clinical study to evaluate fusion status and patient reported outcomes using the Spira-C titanium interbody cage for degenerative disc disease where single-level ACDF surgery is indicated. The treatment group will consist of 40 subjects treated with the Spira™-C interbody device at one level. Patients with a diagnosis of cervical degenerative disc disease and/or spinal stenosis, radiculopathy or myelopathy and planning to undergo a 1-level ACDF surgery between C3-C7 will be screened and consented, if eligibility requirements are met. Once the subject has been enrolled and the surgery has taken place; data will be collected regarding the surgical details will be collected. Subjects will be followed up postoperatively at 6-weeks, 3-months, 6-months, and 12-months as per standard of care, at the private practice or clinic. Subjects will be asked to complete questionnaires regarding pain, function, and quality of life before and after surgery during the postoperative follow-up visits. Radiographic assessments will be performed at all postoperative visits; fusion status will be measured using cervical x-rays and CT scan at 12 months. Radiographs will also be utilized to assess for device-related complications, including implant failure. Any clinically significant complications related to the device will be recorded as an adverse event. This study design reflects the current standard of care for cervical degenerative disc disease and spinal stenosis with symptoms of radiculopathy or myelopathy. Data collected from subjects treated with the Spira™-C Interbody Device will be compared to historical data based on literature review of polyetheretherketone (PEEK) cage fusion rates and patient reported outcomes. Anterior cervical discectomy and fusion using an interbody device with plate and screw fixation is the treatment of choice after conservative therapies (non-surgical, i.e., physical therapy, epidural steroid injections, pain medications) have been exhausted.

Interventions

DEVICESpira-C Interbody Device

40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. ≥ 18 years of age and skeletally mature 2. Able to provide consent 3. Undergoing a primary, single-level ACDF between C3-C7 4. Diagnosis of symptomatic degenerative disc disease 5. Neck pain and/or radicular symptoms with a baseline Visual Analog Scale score of ≥ 4cm (0-10cm scale) 6. Baseline Neck Disability Index score of ≥ 20 7. Attempted at least 6-weeks of conservative non-operative treatment

Exclusion criteria

1. Any prior history of cervical fusion 2. Requires cervical fusion of more than one level 3. Acute cervical spine trauma requiring immediate intervention 4. BMI \> 40 5. Active systemic bacterial or fungal infection or infection at the operative site 6. History of vertebral fracture or osteoporotic fracture 7. Current treatment with chemotherapy, radiation, immunosuppression or chronic steroid therapy 8. History of osteoporosis, osteopenia, or osteomalacia that would contraindicate spinal surgery 9. Psychological or physical condition in the opinion of the investigator that would interfere with completing study participation including completion of patient reported outcomes 10. History of neurological condition in the opinion of the investigator that may affect cervical spine function and pain assessments 11. Subjects with a history of cancer must be disease free for at least 3 years; with the exception of squamous cell skin carcinoma 12. Pregnant, or plans on becoming pregnant 13. History of allergy to titanium

Design outcomes

Primary

Measure	Time frame	Description
Successful Cervical Fusion Measured Radiographically	12 months postoperative	Count of participants with successful cervical fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no development of pseudoarthrosis, and no presence of radiolucency at the treated cervical level

Secondary

Measure	Time frame	Description
Decreased Neck Disability Index for Pain and Function	12 months postoperative	Count of participants with equal to or greater than a 15-point decrease in patient reported outcomes as measured by Neck Disability Index (0-100 point scale, 0 = least amount disability, 100 = most severe disability) from baseline to 12-months.
Increased Quality of Life Measured by Short Form Health Survey-36 (SF-36)	12 months postoperative	Count of participants with Equal to or greater than 15-point increase in patient reported general health score as measured by SF-36 (0-100 point scale, 0 = low favorable health state and 100 = most favorable health state) from baseline to 12-months.
Eating Assessment Tool-10 for Dysphagia	12 months postoperative	Count of participants with score of less than 3 or equal to baseline in patient reported outcomes as measured by Eating Assessment Tool-10 from baseline to 12-months.
Decreased Visual Analog Scale for Neck Pain	12 months postoperative	Count of participants with equal to or greater than a 2-point decrease in patient reported outcomes as measured by Visual Analog Scale for pain (0-10 point scale, 0 = no pain and 10 = severe amount of pain) from baseline to 12-months in the neck region.
Count of Participants With Revision Surgery by Month 12	12 months postoperative	Count of participants with revision surgery by month 12
Count of Participants With Development of Pseudoarthrosis by Month 12	12 months postoperative	Count of participants with development of pseudoarthrosis by month 12
Worsening Neurological Deficit Per Cervical Spine Examination	12 months postoperative	Count of participants with new or worsening neurological cervical spine deficit as evaluated by cervical spine (motor and sensory) examination from baseline to 12-months.

Countries

United States

Participant flow

Pre-assignment details

This is a single-arm, post market study to evaluate fusion status and patient reported outcomes using the FDA approved Spira-C Titanium Interbody Device at one level. Patients with a diagnosis of cervical degenerative disc disease and/or spinal stenosis, radiculopathy or myelopathy and planning to undergo a 1-level ACDF surgery between C3-C7 were screened and enrolled in the study.

Participants by arm

Arm	Count
Spira-C Interbody Device subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device Spira-C Interbody Device: subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device	12
Total	12

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	did not complete 12 month CT scan	1
Overall Study	Lost to Follow-up	4
Overall Study	Screen Failure after consent	1

Baseline characteristics

Characteristic	Spira-C Interbody Device	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	12 Participants	—
Age, Continuous	53 Age in years	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United States	12 participants	—
Sex: Female, Male Female	4 Participants	—
Sex: Female, Male Male	8 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 13
other Total, other adverse events	0 / 13
serious Total, serious adverse events	0 / 13

Outcome results

Primary

Successful Cervical Fusion Measured Radiographically

Count of participants with successful cervical fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no development of pseudoarthrosis, and no presence of radiolucency at the treated cervical level