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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05305430




Registration number
NCT05305430
Ethics application status
Date submitted
22/03/2022
Date registered
31/03/2022

Titles & IDs
Public title
Real World Data Collection on the Synergy Cervical Disc
Scientific title
A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc
Secondary ID [1] 0 0
CP 21-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Disc Degeneration 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Synergy Cervical Disc System

Prospective - All patients for whom the decision has been made to have the Synergy Disc implanted at participating investigative centers and give informed consent to participate in the prospective segment of this protocol, per country-specific requirements, will be enrolled in the prospective portion of this protocol.

Retrospective - Patients who have previously had a Synergy Spine Solutions Synergy Disc implanted will be eligible for inclusion in the retrospective data collection; a waiver of consent, or informed consent, for retrospective data collection from the medical records of the implanting surgeon will be sought per country-specific regulations as applicable.


Treatment: Devices: Synergy Cervical Disc System
motion preservation disc
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Neck Disability Index
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Device Related or Device Procedure Related Adverse Events
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
Visual Analog (VAS) pain
Timepoint [1] 0 0
pre-operative and 6 week, 3 months, 6 months, 12 months, annually post operatively
Secondary outcome [2] 0 0
Patient Satisfaction
Timepoint [2] 0 0
6 weeks, 3 months, 6 months, 12 months, annually post operatively
Secondary outcome [3] 0 0
Nurick's Criteria
Timepoint [3] 0 0
pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Secondary outcome [4] 0 0
Odom's Criteria
Timepoint [4] 0 0
6 weeks, 3 months, 6 months, 12 months, annually post operatively
Secondary outcome [5] 0 0
Neurologic Function
Timepoint [5] 0 0
6 weeks, 3 months, 6 months, 12 months, annually post operatively

Eligibility
Key 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.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2028
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Greenslopes Private Hospital - Brisbane
Recruitment hospital [2] 0 0
Dr. Greg Malham - Melbourne
Recruitment hospital [3] 0 0
Spine and Scoliosis Research Associates Australia Ltd - Windsor
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Windsor

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Synergy Spine Solutions
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Pacific Clinical Research Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jane M Jacob, PhD
Address 0 0
Sponsor GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jane M Jacob, PhD
Address 0 0
Country 0 0
Phone 0 0
+1 512-289-5370
Fax 0 0
Email 0 0
janejacob@synergyspinesolutions.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05305430