The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
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ClinicalTrials.gov Identifier: NCT05740176 |
Recruitment Status :
Recruiting
First Posted : February 22, 2023
Last Update Posted : January 17, 2024
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Sponsor:
Synergy Spine Solutions
Collaborator:
MCRA
Information provided by (Responsible Party):
Synergy Spine Solutions
Tracking Information | |||||||||
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First Submitted Date ICMJE | February 3, 2023 | ||||||||
First Posted Date ICMJE | February 22, 2023 | ||||||||
Last Update Posted Date | January 17, 2024 | ||||||||
Actual Study Start Date ICMJE | June 1, 2023 | ||||||||
Estimated Primary Completion Date | June 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery | ||||||||
Official Title ICMJE | 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 Two-Level Symptomatic Cervical Degenerative Disc Disease (DDD) | ||||||||
Brief Summary | A multicenter, prospective, non-randomized, historically controlled study. To demonstrate the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) to treat cervical degenerative disc disease (DDD) in subjects who are symptomatic at two levels from C3 to C7 are and are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, and 3, 6, 12, and 24 months after surgery. Follow-up will continue annually until the last patient reaches 24-month follow-up. The primary analysis will occur at 24 months. | ||||||||
Detailed Description | The proposed investigation is a prospective, non-randomized, multi-center, historically controlled comparison of the Synergy Disc to the control of conventional anterior cervical discectomy and fusion (ACDF) surgery in patients with cervical DDD. A total of 200 patients will be enrolled to the investigational group .The objective of this clinical study is to evaluate the safety and effectiveness of the two-level Synergy Disc compared to conventional two-level ACDF in skeletally mature patients for reconstruction of two contiguous discs from C3 to C7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces that are unresponsive to conservative management. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: multicenter, prospective, historically controlled Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Cervical Degenerative Disc Disease | ||||||||
Intervention ICMJE | Device: Anterior Cervical Discectomy and Fusion
Anterior cervical discectomy is a surgical procedure that was developed to treat damaged cervical discs by relieving pressure on the nerve roots or on the spinal cord by removing the ruptured disc. The operation is performed by reaching the cervical spine through a small incision in the front of the neck. The soft tissues of the neck are then separated allowing for the disc to be removed. Anterior cervical discectomy has proven to be a safe and effective procedure for the treatment of degenerative disc disease. The anterior approach allows direct visualization of the entire interspace and wide decompression of the anterior aspect cervical spinal cord and nerve roots. It may be undertaken in cases of multilevel disease and interbody fusion may be performed if required
Other Name: ACDF
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Study Arms ICMJE | 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 restore kinematics to the cervical spine. The Synergy Disc is intended for use in the cervical spine for reconstruction of the disc following a two level discectomy for intractable radiculopathy and/or myelopathy.
Intervention: Device: Anterior Cervical Discectomy and Fusion
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
200 | ||||||||
Original Enrollment ICMJE | Not Provided | ||||||||
Estimated Study Completion Date ICMJE | December 1, 2025 | ||||||||
Estimated Primary Completion Date | June 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: In order to be eligible to participate in this study, subjects must meet all of the following criteria:
Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
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Administrative Information | |||||||||
NCT Number ICMJE | NCT05740176 | ||||||||
Other Study ID Numbers ICMJE | CP 110-0004 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Synergy Spine Solutions | ||||||||
Original Responsible Party | [Redacted] | ||||||||
Current Study Sponsor ICMJE | Synergy Spine Solutions | ||||||||
Original Study Sponsor ICMJE | [Redacted] | ||||||||
Collaborators ICMJE | MCRA | ||||||||
Investigators ICMJE |
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PRS Account | Synergy Spine Solutions | ||||||||
Verification Date | January 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |