Clinical trial NCT05305430: Real World Data Collection on the Synergy Cervical Disc
Official title: A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Disc Degeneration
Keywords: degenerative disc
cervical
radiculopathy
myelopathy
motion preservation
Lead sponsor: Synergy Spine Solutions
Sponsor class: INDUSTRY
Collaborators: name: Pacific Clinical Research Group
First posted: 2022-03-31
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both retrospective and prospective study subjects that have cervical degenerative disc disease requiring treatment with the Synergy Spine Solutions Synergy Disc.

Prospective study cohort: All patients for whom it has been decided that the Synergy Spine Solutions Synergy Disc will be implanted at participating investigative centers and give informed consent to participate in the prospective segment of this protocol.

Retrospective study cohort: Patients who have previously had a Synergy Spine Solutions Synergy Disc implanted. If required by local regulations, informed consent will be sought and received from the participating patient prior to data collection from the medical records per country-specific regulations.

Brief summary: This trial is a real world data (RWD) collection observational study, comprised of both prospective and retrospective arms, that will examine the safety and effectiveness of the Synergy Cervical Disc System in patients with degenerative cervical disc disease.


Eligibility criteria: Inclusion Criteria:

1. Over the age of 21 at the time of the surgery.
2. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted
3. Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy
4. Intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression: herniated disc and/or osteophyte formation
5. Symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (CT, MRI, x-rays, etc.)
6. Failed a minimum of 6 weeks conservative treatment
7. Written informed consent given by subject, as applicable.

Exclusion Criteria:

1. Moderate to advanced spondylosis
2. Diagnosis of osteoporosis
3. Active systemic infection or infection at the operative site
4. Pregnancy
5. Marked cervical instability on lateral, coronal, or flexion/extension radiographs
6. Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level
7. Severe pathology of the facet joints of the involved vertebral bodies
8. Previous diagnosis of osteopenia or osteomalacia
9. More than one immobile vertebral level between C1 and T1 from any cause
10. Morbid obesity
11. Currently a prisoner

Primary outcomes:
measure: Neck Disability Index
timeFrame: 12 months
measure: Device Related or Device Procedure Related Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Visual Analog (VAS) pain
timeFrame: pre-operative and 6 week, 3 months, 6 months, 12 months, annually post operatively
measure: Patient Satisfaction
timeFrame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
measure: Nurick's Criteria
timeFrame: pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively
measure: Odom's Criteria
timeFrame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
measure: Neurologic Function
timeFrame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Dr. Greg Malham
state: Victoria
city: Windsor
country: Australia
facility: Spine and Scoliosis Research Associates Australia Ltd
state: Victoria
Study officials:
affiliation: Sponsor GmbH
name: Jane M Jacob, PhD
role: STUDY_DIRECTOR
References: