Trial Outcomes & Findings for Prospective Study of Fusion Rates Using Spira-C Device for Anterior Cervical Discectomy and Fusion Surgery (NCT NCT03786432)

NCT ID: NCT03786432

Last Updated: 2023-07-28

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: 12 months postoperative
• Results posted on: 2023-07-28

Participant Flow

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.

Participant milestones

Measure	Spira-C Interbody Device 40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device Spira-C Interbody Device: 40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device
Overall Study STARTED	13
Overall Study Completed 12 Month Visit	8
Overall Study Completed 12 Month CT Scan	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Spira-C Interbody Device 40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device Spira-C Interbody Device: 40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device
Overall Study Screen Failure after consent	1
Overall Study Lost to Follow-up	4
Overall Study did not complete 12 month CT scan	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Spira-C Interbody Device n=12 Participants 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
Age, Categorical <=18 years	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants
Age, Continuous	53 Age in years n=12 Participants
Sex: Female, Male Female	4 Participants n=12 Participants
Sex: Female, Male Male	8 Participants n=12 Participants
Region of Enrollment United States	12 participants n=12 Participants

PRIMARY outcome

Timeframe: 12 months postoperative

Population: 4 were lost to follow-up, 1 did not complete CT scan and 1 screen failure-no data out of 13 enrolled.

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

Outcome measures

Measure	Spira-C Interbody Device n=7 Participants 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
Successful Cervical Fusion Measured Radiographically	6 Participants

SECONDARY outcome

Timeframe: 12 months postoperative

Population: 4 were lost to follow-up and 1 screen failure-no data out of 13 enrolled.

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.

Outcome measures

Measure	Spira-C Interbody Device n=8 Participants 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
Decreased Visual Analog Scale for Neck Pain	6 Participants

SECONDARY outcome

Timeframe: 12 months postoperative

Population: 4 were lost to follow-up and 1 screen failure-no data out of 13 enrolled.

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.

Outcome measures

Measure	Spira-C Interbody Device n=8 Participants 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
Decreased Neck Disability Index for Pain and Function	6 Participants

SECONDARY outcome

Timeframe: 12 months postoperative

Population: 4 were lost to follow-up and 1 screen failure-no data out of 13 enrolled.

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.

Outcome measures

Measure	Spira-C Interbody Device n=8 Participants 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
Increased Quality of Life Measured by Short Form Health Survey-36 (SF-36)	3 Participants

SECONDARY outcome

Timeframe: 12 months postoperative

Population: 4 were lost to follow-up and 1 screen failure-no data out of 13 enrolled.

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.

Outcome measures

Measure	Spira-C Interbody Device n=8 Participants 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
Eating Assessment Tool-10 for Dysphagia	7 Participants

SECONDARY outcome

Timeframe: 12 months postoperative

Population: 4 were lost to follow-up, 1 did not complete CT scan and 1 screen failure-no data out of 13 enrolled.

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.

Outcome measures

Measure	Spira-C Interbody Device n=7 Participants 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
Worsening Neurological Deficit Per Cervical Spine Examination	6 Participants

SECONDARY outcome

Timeframe: 12 months postoperative

Population: 4 were lost to follow-up and 1 screen failure-no data out of 13 enrolled.

Count of participants with revision surgery by month 12

Outcome measures

Measure	Spira-C Interbody Device n=8 Participants 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
Count of Participants With Revision Surgery by Month 12	0 Participants

SECONDARY outcome

Timeframe: 12 months postoperative

Population: 4 were lost to follow-up, 1 did not complete CT scan and 1 screen failure-no data out of 13 enrolled.

Count of participants with development of pseudoarthrosis by month 12

Outcome measures

Measure	Spira-C Interbody Device n=7 Participants 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
Count of Participants With Development of Pseudoarthrosis by Month 12	1 Participants

Adverse Events

Spira-C Interbody Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Grace San Agustin

William Beaumont University Hospital

Phone: 248 551 6679

Email: grace.sanagustin@beaumont.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place