INFUSE™ BONE GRAFT/CORNERSTONE-SR™ Allograft Ring/ATLANTIS™ Anterior Cervical Plate- Pilot Study

NCT01491399 | Completed

• 1 other identifier: C-9702 Cornerstone ACDF pilot
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this clinical trial is to assess the safety and effectiveness of the Investigational implant as compared to the Control implant in the treatment of patients with one level or two adjacent levels of cervical symptomatic degenerative disc disease.

Conditions

Degenerative Cervical Disc Disease

Outcome Measures

Primary Outcomes (3)

• Fusion

  Fusion is defined as: * No evidence of motion as defined by: less than 4° difference in angular motion between flexion and extension as seen on the lateral flexion/extension radiographs. * No radiolucency greater than 2mm of thickness covering more than 50% of superior or inferior graft surface. * Evidence of bridging trabecular bone.

  24 month

• Pain/Disability Status

  The self-administered Neck Disability Index will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score \>= 15

  24 month

• Neurological Status

  Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale.

  24 month

Secondary Outcomes (6)

• Time to fusion

  24 month

• Hip (Donor Site) Pain

  24 month

• General Health Status (SF-36)

  24 month

• Pain Status (neck pain, arm pain)

  24 month

• Patient Satisfaction

  24 month

Study Arms (2)

INFUSE™ Bone Graft/CORNERSTONE-SR™

EXPERIMENTAL

Device: INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™

Autogenous bone/CORNERSTONE-SR™

ACTIVE COMPARATOR

Device: Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™

Interventions

INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™ DEVICE

Cornerstone-SR™ allograft bone containing recombinant human Bone Morphogenetic Protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS) used in conjunction with ATLANTIS™ anterior cervical plate system.

Also known as: recombinant human Bone Morphogenetic Protein-2, Infuse

INFUSE™ Bone Graft/CORNERSTONE-SR™

Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™ DEVICE

Cornerstone-SR™ allograft bone packed with autogenous iliac crest bone graft used in conjunction with ATLANTIS™ anterior cervical plate system.

Also known as: Autograft

Autogenous bone/CORNERSTONE-SR™

Eligibility Criteria

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

You may qualify if:

• Cervical disc disease defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by diagnostic imaging procedures:
• herniated disc;
• osteophyte formation;
• decreased disc height;
• thickening of ligamentous tissue;
• disc degeneration; and/or
• facet joint degeneration.
• Has preoperative Neck Disability Index score \>= 30;
• C2-C3 disc to C7-Tl disc level(s) of involvement.
• One or two adjacent levels requiring fusion;
• No previous surgical intervention at the involved fusion level(s);
• Unresponsive to nonoperative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root or spinal cord compression in face of continued nonoperative management;
• Age \> 18 years at time of surgery;
• Is female of child-bearing potential, who is not pregnant or nursing, and who agrees to not get pregnant for 1 year following surgery;
• Willingness to comply with study plan and sign the consent form.

You may not qualify if:

• Has cervical spinal condition requiring surgical treatment other than symptomatic cervical disc disease at the involved level(s).
• Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that anterior plating would be contraindicated.
• Has presence of spinal metastases.
• Has overt or active bacterial infection, either local or systemic.
• Has fever (temperature \> 101°F oral) at the time of surgery.
• Has a documented titanium alloy allergy or intolerance.
• Is mentally incompetent. If questionable, obtain psychiatric consult.
• Is a prisoner.
• Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage.
• Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs.
• Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
• Has a history of exposure to injectable collagen implants.
• Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
• Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/ACS implantation.
• Has received any previous exposure to any/all BMP's of either human or animal extraction.

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

MeSH Terms

Interventions

Transplantation, Autologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 14, 2011
• Study Start: September 1, 1999
• Primary Completion: March 1, 2003
• Study Completion: March 1, 2003
• Last Updated: May 17, 2023

Record last verified: 2023-05