Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative Disease

NCT07721493 | Not Yet Recruiting FDA Device

• 1 other identifier: CLN-PMT-149
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to evaluate the treatment of patients with two-level cervical degenerative disease using a combination of Anterior Cervical Discectomy and Fusion (ACDF) and Posterior Cervical Fusion (PCF) procedures. The primary outcome measure is the rate of fusion success in the investigational treatment arm (ACDF + PCF) compared with the control arm (ACDF alone) at the 12-month follow-up visit. Researchers will compare the investigational treatment arm (ACDF + PCF) to the control arm (ACDF alone) to assess superiority in terms of fusion success rate.

Conditions

Degenerative Disc Disease(DDD)

Keywords

cervical spine; myelopathy; radiculopathy; cervical spine fusion; circumferential cervical fusion; degenerative disc disease; 2-Level Cervical Degenerative Disease; Anterior Cervical Discectomy and Fusion

Outcome Measures

Primary Outcomes (1)

• Superiority in Fusion Success in Treatment Arm (CCF) Compared to Control Arm (ACDF)

  Superiority in the rate of fusion success in the treatment arm (CCF) as compared to the control arm (ACDF) at the 12-month visit. An individual subject is considered a fusion success if there is evidence of bridging trabecular bone across endplates at all levels treated with no re-intervention.

  12 months

Study Arms (2)

Anterior Cervical Discectomy and Fusion (ACDF)

ACTIVE COMPARATOR

Anterior Cervical Discectomy and Fusion (ACDF), which is a standard of care procedure

Procedure: Anterior Cervical Discectomy and Fusion

Circumferential Cervical Fusion (CCF)

EXPERIMENTAL

Circumferential Cervical Fusion (CCF), which is a combination of ACDF and Posterior Cervical Fusion (PCF)

Device: Circumferential Cervical Fusion (CCF)

Interventions

Circumferential Cervical Fusion (CCF) DEVICE

Circumferential Cervical Fusion (CCF), which is a combination of ACDF and Posterior Cervical Fusion (PCF) performed during the same surgical procedure, irrespective of order. The PCF procedure is performed using CORUS™ Spinal System-X to access and prepare the joint for fusion, followed by placement of PCSS 3D and delivery of an allograft demineralized bone matrix (DBM).

Circumferential Cervical Fusion (CCF)

Anterior Cervical Discectomy and Fusion PROCEDURE

ACDF is performed using standard instruments and completed with a titanium interbody implant and anterior semi-constrained plate. The plate is intended to stabilize the treated levels until fusion occurs.

Anterior Cervical Discectomy and Fusion (ACDF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age (Skeletally Mature)
• Indicated for ACDF treatment of degenerative disc disease (DDD) between and including C3-C7 at 2 contiguous levels as determined by the following:
• diagnosis of radiculopathy, myelopathy or myeloradiculopathy of the cervical spine, with pain, including at least one of the following: i. Neck and/or arm pain, ii. Decreased muscle strength, and iii. Abnormal sensation including hyperesthesia or hypoesthesia; and/or Abnormal reflexes.
• radiographically determined pathology at the levels to be treated correlating to primary symptoms including at least one of the following: i. Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc, ii. Degenerative spondylosis on MRI, and iii. Disc herniation on MRI.
• NDI Score of ≥ 15/50
• Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
• at least six weeks from radiculopathy or myeloradiculopathy symptom onset; or
• have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment.
• Reported to be medically cleared for surgery
• 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.

You may not qualify if:

• Has, in the Investigator's opinion, any disease or condition that would preclude accurate radiographic evaluation of any treated vertebrae (e.g. morbid obesity)
• Active systemic infection or infection at the operative site
• History of or anticipated treatment for active systemic infection, including HIV or Hepatitis C
• Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury that may prevent device placement
• 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 two levels
• Diagnosis of Spondylolisthesis, grade \>2
• Overt (Segmental) instability measured as a movement on dynamic flex/extend x-rays \> 3.5 mm
• Congenital bony and/or spinal cord abnormalities that affect spinal stability
• Diagnosis of Paget's disease, osteomalacia, or any other metabolic bone disease other than osteopenia
• 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
• Has an uncontrolled seizure disorder
• Use of epidural steroids within 14 days prior to surgery

Sponsors & Collaborators

• Providence Medical Technology, Inc.: lead

Study Sites (1)

The Orthopaedic Institute

Paducah, Kentucky, 42001, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spinal Cord Diseases; Radiculopathy; Klippel-Feil Syndrome

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Dysostoses; Bone Diseases, Developmental; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena

Study Officials

• Matt Jenkins

  Providence Medical Technology, Inc.

  STUDY DIRECTOR

Central Study Contacts

Matt Jenkins

CONTACT

805-450-4965; mjenkins@providencemt.com

Stacey Underwood

CONTACT

520-262-3704; sunderwood@providencemt.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomly assigned to either the treatment or control arms at 1:1 ratio.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled, multicenter study

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 23, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

US (1)