RHINE™ Cervical Disc Study
Research type
Research Study
Full title
RHINE™ Cervical Disc Prospective Observational Clinical Study
IRAS ID
225195
Contact name
Gladys Annan
Contact email
Sponsor organisation
K2M, Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The purpose of the RHINE™ Cervical Disc Prospective Observational Clinical Study Protocol is to collect data on patient’s clinical and radiographic outcomes from neck (cervical) spinal surgery utilizing RHINE™ Cervical Disc (“RHINE Disc”). Eligible patients include those aged 18 and over, whose neck spine condition requires treatment. That treatment includes the removal of the disc between the bones making up the spine and replacement of the disc with an artificial disc to aid in the steadying and re-positioning of the cervical spine. The RHINE Disc is made of medical grade titanium alloy and a compressible core designed to provide shock absorption and controlled motion very close to the natural disc.
Patients will complete standard health related questionnaires and X-rays.
A total of 166 patients are being recruited for this study from approximately 10 study sites in 6-8 European countries.
Patients will be required to return for Follow up visits at the following time points; between 6-12 weeks, 6 months, 12 months, 24 months and 60 months post-procedure.
There are no experimental products, procedures, or tests involved in this study; only data on how the patient is doing before and after surgery will be collected.REC name
London - Queen Square Research Ethics Committee
REC reference
18/LO/0228
Date of REC Opinion
3 Apr 2018
REC opinion
Further Information Favourable Opinion