Clinical trial NCT05880823: Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc
Official title: A Single Site Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc®
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Degenerative Disc Disease
Lead sponsor: Synergy Spine Solutions
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2023-05-30
Enrollment: 50
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: The patients for this study will be recruited from the physician's practice.

Brief summary: This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease.


Eligibility criteria: Inclusion Criteria:

* Age 21 or above at the time of the surgery.
* Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted
* Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy
* 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
  * 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.)
  * Failed a minimum of 6 weeks conservative treatment
* Written informed consent given by subject.

Exclusion Criteria:

* Exclusion Criteria: All answers must be NO to be eligible for the study.
* Moderate to advanced spondylosis
* Diagnosis of osteoporosis
* Active systemic infection or infection at the operative site
* Pregnancy
* Marked cervical instability on lateral, coronal, or flexion/extension radiographs
* Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level
* Severe pathology of the facet joints of the involved vertebral bodies
* Previous diagnosis of osteopenia or osteomalacia
* More than one immobile vertebral level between C1 and T1 from any cause
* Morbid obesity
* Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)

Primary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: 12 months
measure: Device Related or Device Procedure Related Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Neck and Arm Pain Measurement
timeFrame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
measure: Patient Satisfaction
timeFrame: 6 week, 3 month, 6 month, 12 month, 24 month
measure: Motor and Sensory Function in the Arm
timeFrame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
measure: Nurick's Criteria
timeFrame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
measure: Odom's criteria
timeFrame: 6 week, 3 month, 6 month, 12 month, 24 month
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Neurochirurgie am Gasteig
state: Bavaria
Study officials:
affiliation: Synergy Spine Solutions
name: Jane M Jacob, PhD
role: STUDY_DIRECTOR
References: