Active — Not RecruitingNot Applicable

The Synergy Disc To Anterior Cervical Discectomy and Fusion

United States175 participantsStarted 2020-10-30

Plain-language summary

A multicenter, prospective, non-randomized, historically controlled study. 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 only one level from C3 to C7 that are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 18 70 years;
✓. Diagnosis of radiculopathy or myelopathy of the cervical spine, with either radiculopathy symptoms - pain, paresthesia, or paralysis in a specific nerve root distribution C4, C5, C6, or C7, including at least one of the following: arm/shoulder pain (at least 30 mm on 100 mm VAS scale); decreased muscle strength of at least one level on the 0-5 scale described below; abnormal sensation, including hyperesthesia or hypoesthesia; and/or abnormal reflexes; or myelopathy symptoms including positive Romberg evaluation, abnormal heel/toe walk, pathologic hyperreflexia or clonus in lower extremity, positive Babinski, or positive Hoffman's;
✓. Symptomatic at only one level from C3-C4 to C6-C7;
✓. Radiographically determined pathology at level to be treated correlating to primary symptoms, including at least one of the following:
✓. Decreased disc height compared to adjacent levels on radiographic film, CT, or MRI
✓. Degenerative spondylosis on CT or MRI
✓. Disc herniation on CT or MRI.
✓. Neck Disability Index (NDI) score ≥ 30/100;

Exclusion criteria

What they're measuring

NDI

Timeframe: 24 Month

Neurological Assessment

Timeframe: 24 Month

SSI

Timeframe: 24 Month

Device Related AE

Timeframe: 24 Month

Trial details

NCT IDNCT04469231

SponsorSynergy Spine Solutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-19

View on ClinicalTrials.gov More Cervical Degenerative Disc Disease trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 18 70 years;
✓. Diagnosis of radiculopathy or myelopathy of the cervical spine, with either radiculopathy symptoms - pain, paresthesia, or paralysis in a specific nerve root distribution C4, C5, C6, or C7, including at least one of the following: arm/shoulder pain (at least 30 mm on 100 mm VAS scale); decreased muscle strength of at least one level on the 0-5 scale described below; abnormal sensation, including hyperesthesia or hypoesthesia; and/or abnormal reflexes; or myelopathy symptoms including positive Romberg evaluation, abnormal heel/toe walk, pathologic hyperreflexia or clonus in lower extremity, positive Babinski, or positive Hoffman's;
✓. Symptomatic at only one level from C3-C4 to C6-C7;
✓. Radiographically determined pathology at level to be treated correlating to primary symptoms, including at least one of the following:
✓. Decreased disc height compared to adjacent levels on radiographic film, CT, or MRI
✓. Degenerative spondylosis on CT or MRI
✓. Disc herniation on CT or MRI.
✓. Neck Disability Index (NDI) score ≥ 30/100;