The Synergy Disc To Anterior Cervical Discectomy and Fusion
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|ClinicalTrials.gov Identifier: NCT04469231|
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : September 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cervical Degenerative Disc Disease||Device: Anterior Cervical Discectomy & Fusion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A multicenter, prospective, non-randomized, historically controlled study.|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center, Prospective, Historically Controlled Pivotal Trial Comparing The Safety And Effectiveness Of The Synergy Disc To Anterior Cervical Discectomy And Fusion In Patients With One-Level Symptomatic Cervical Degenerative Disc Disease (DDD).|
|Actual Study Start Date :||October 30, 2020|
|Estimated Primary Completion Date :||January 1, 2024|
|Estimated Study Completion Date :||January 1, 2026|
Experimental: Synergy Disc
The Synergy Disc is a cervical disc prosthesis that can be inserted between C3-C7 in skeletally mature patients after anterior discectomy to provide restoration of motion to the functional spinal unit. The Synergy Disc is designed to restoring kinematics to the cervical spine. The Synergy Disc is intended for use in the cervical spine for reconstruction of the disc following a single level discectomy for intractable radiculopathy and/or myelopathy.
Device: Anterior Cervical Discectomy & Fusion
Other Name: ACDF
- NDI [ Time Frame: 24 Month ]≥ 15-point improvement in NDI Score (out of 100) in subjects at 24 months compared with baseline
- Neurological Assessment [ Time Frame: 24 Month ]Maintenance or improvement in neurological status (motor and sensory only) at 24 months compared to baseline
- SSI [ Time Frame: 24 Month ]No study failure due to secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index level
- Device Related AE [ Time Frame: 24 Month ]Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event as adjudicated by the CEC.
- SF-3 [ Time Frame: 6 Week, 3, 6, 12, and 24 Month ]Health Survey (SF-36) at baseline and at each follow-up time-point
- VAS [ Time Frame: 6 Week, 3, 6, 12, and 24 Month ]Visual analogue scale (VAS) will be used to evaluate pain where a change of at least 20mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up time-point. Left and Right arm/shoulder pain as measured on a 100mm VAS at baseline and at each follow-up time-point. Please note, this assessment will include a "Worst" to pool together the left or right arm/shoulder scores with the higher baseline score. VAS Hoarseness on a 100mm scale.
- Patient Satisfaction [ Time Frame: 6 Week, 3, 6, 12, and 24 Month ]Patient Satisfaction Questionnaire
- BZ Score [ Time Frame: 6 Week, 3, 6, 12, and 24 Month ]Bazaz Dysphagia Score at 24 months compared to baseline
- Odom's Criteria [ Time Frame: 6 Week, 3, 6, 12, and 24 Month ]Results at 24 months for the investigational Synergy Disc and at 24 months for the control ACDF will also be categorized by the physician according to Odom's Criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469231
|Contact: Lisa Beckfirstname.lastname@example.org|
|Contact: Nicole Harrisemail@example.com|