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

Study of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the CORNERSTONE-SR™Allograft Ring and ATLANTIS™ Anterior Cervical Plate System in Treatment of Patients With Degenerative Cervical Disc Disease

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Cervical Disc Disease
• Intervention / Treatment: Device: INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™; Device: Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Has preoperative Neck Disability Index score >= 30;
3. C2-C3 disc to C7-Tl disc level(s) of involvement.
4. One or two adjacent levels requiring fusion;
5. No previous surgical intervention at the involved fusion level(s);
6. 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;
7. Age > 18 years at time of surgery;
8. Is female of child-bearing potential, who is not pregnant or nursing, and who agrees to not get pregnant for 1 year following surgery;
9. Willingness to comply with study plan and sign the consent form.

Exclusion Criteria:

1. Has cervical spinal condition requiring surgical treatment other than symptomatic cervical disc disease at the involved level(s).
2. Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that anterior plating would be contraindicated.
3. Has presence of spinal metastases.
4. Has overt or active bacterial infection, either local or systemic.
5. Has fever (temperature > 101°F oral) at the time of surgery.
6. Has a documented titanium alloy allergy or intolerance.
7. Is mentally incompetent. If questionable, obtain psychiatric consult.
8. Is a prisoner.
9. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage.
10. 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.
11. Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
12. Has a history of exposure to injectable collagen implants.
13. Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
14. 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.
15. Has received any previous exposure to any/all BMP's of either human or animal extraction.
16. Has a history of allergy to bovine products or a history of anaphylaxis.
17. Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers- Danlos syndrome, or osteogenesis imperfecta).
18. Has a condition which requires postoperative medications that interfere with fusion, such as steroids, excluding routine perioperative anti-inflammatory drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INFUSE™ Bone Graft/CORNERSTONE-SR™	Device: INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™; 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.; Other Names: Infuse; recombinant human Bone Morphogenetic Protein-2
Active Comparator: Autogenous bone/CORNERSTONE-SR™	Device: Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™; Cornerstone-SR™ allograft bone packed with autogenous iliac crest bone graft used in conjunction with ATLANTIS™ anterior cervical plate system.; Other Names: Autograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
General Health Status (SF-36)	24 month
Patient Satisfaction	24 month
Patient Global Perceived Effect	24 month
Time to fusion	24 month
Hip (Donor Site) Pain	24 month
Pain Status (neck pain, arm pain)	24 month

Collaborators and Investigators

• Sponsor: Medtronic Spinal and Biologics

Study record dates

Study Major Dates

• Study Start: September 1, 1999
• Primary Completion (Actual): March 1, 2003
• Study Completion (Actual): March 1, 2003

Study Registration Dates

• First Submitted: December 12, 2011
• First Submitted That Met QC Criteria: December 13, 2011
• First Posted (Estimate): December 14, 2011

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Intervertebral Disc Degeneration
• Other Study ID Numbers: C-9702 Cornerstone ACDF pilot