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Safety and Effectiveness of Posterior Cervical Stabilization System (PCSS) as an adjunct to posterior cervical fusion, when used in combination with ACDF in the treatment of multi-level cervical degenerative disease (FUSE Study)

Study Type/Phase: Interventional
Status: Recruiting

The back is made up of donut-shaped bones called vertebrae that are stacked one on top of the other. The vertebrae have cushions between them (discs) that act as shock absorbers. There are two small joints (facet joints) in the back of your neck (posterior) that help your neck and head move along with your vertebrae and discs. Sometimes the discs may collapse and/or burst and cause your neck to become stiff and painful. When this happens, it is called Degenerative Disc Disease (DDD).

The current standard surgical treatment for cervical Degenerative Disc Disease is a procedure called Anterior Cervical Discectomy with Fusion (ACDF) completed with allograft or autograft. This means that the damaged discs are removed and a bone graft (bone taken from another part of your body (autograft) or from a deceased donor (allograft) is inserted between the bones to help the bones grow together and to decompress the spinal cord and nerve roots. A plate and screws are inserted in addition to the bone graft to serve as a splint to prevent movement in the spine until the bones grow together.

The purpose of this research study is to evaluate the safety and effectiveness of a Circumferential Cervical Fusion (CCF) compared to an ACDF alone for patients with cervical DDD that require treatment at 3 levels of their cervical spine. A CCF procedure is the combination of a Posterior Cervical Fusion (PCF) and the ACDF procedure described above. In this study the PCF procedure will use Posterior Cervical Stabilization System (PCSS), which is considered an investigational device. The PCF procedure with PCSS involves inserting two small cage-like devices in the middle of your facet joints and securing them with a screw. Similar to ACDF, the small cages will prevent movement in your facet joints until your bones grow together.

The combination of both of these surgical approaches, ACDF and PCF, may provide additional stabilization that is often needed for subjects that have more than two levels that need to be treated as your bones may have trouble growing together.

This is a randomized study to evaluate the safety and effectiveness of the PCSS developed for patients with DDD. This device has not been approved by the U.S. Food and Drug Administration (FDA).

About 330 subjects will take part in this study at 20 sites. Approximately 50 subjects will take part in this study at El Camino Health Los Gatos.

Speak with your doctor to determine whether you meet the following criteria for participation in this study, partial list below:

Key Inclusion Criteria Key Exclusion Criteria
  • Age 18-80 years
  • Indicated for ACDF treatment of degenerative disc disease (DDD) between and including C3-C7 at 3 contiguous levels
  • NDI Score of ≥15/50
  • Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics)
  • Physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol
  • Written informed consent provided by subject
  • Body Mass Index (BMI) greater than 40 kg/m2
  • Previous trauma to the C3 to C7 levels resulting in significant bony or disco- ligamentous cervical spine injury that may prevent device placements
  • A prior spine surgery or pseudoarthrosis at the operative levels
  • Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention
  • Symptomatic DDD or significant cervical spondylosis at more than three levels
  • Congenital bony and/or spinal cord abnormalities that affect spinal stability
  • Osteoporosis, defined as either the SCORE or MORES ≥ 6 and a DEXA bone density measured T-score of ≤ -2.5
  • Active malignancy or a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and without clinical signs or symptoms of the malignancy for at least five years
  • A concomitant condition requiring daily, high-dose oral and/or inhaled steroids
  • Fixed or permanent neurologic deficit related to the target treatment levels that cannot be improved with surgical decompression
  • Is pregnant or nursing at time of screening, or with plans to become pregnant within the next three years
  • A current or recent history (≤ 1 year prior to screening) of substance abuse (alcoholism and/or narcotic addiction) that required treatment
  • Long term use (>6 months) of opioids (max. daily amount=120 mg morphine equivalents)
  • A mental illness or belongs to a vulnerable population, as determined by the investigator (e.g., prisoner or developmentally disabled), that would compromise ability to provide informed consent or compliance with follow-up requirements
  • Use of any other investigational drug or medical device within the last 30 days prior to surgery
  • A pending personal litigation relating to spinal injury (worker's compensation is not exclusionary)
  • Anticipated or potential relocation greater than 50 miles that may interfere with completion of follow-up examinations

Principal Investigator

Sandeep Gidvani, MD

Sponsor

Providence Medical Technology, Inc.

NCT Number

NCT04229017

Contact

Janet Lamm, Sr. Clinical Research Coordinator
650-962-4566
Janet_lamm@elcaminohealth.org

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

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