An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation

NCT ID: NCT00310440

Last Updated: 2020-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 319 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2019-05-23

Brief Summary

The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not inferior in effectiveness and safety to local autologous bone (control device) when applied in instrumented anterior cervical discectomy and fusion (ACDF) with use of a structural allograft ring in patients with degenerative cervical disc disease..

Detailed Description

Anterior Cervical Discectomy and Fusion (ACDF) is a common surgical treatment option for symptomatic degenerative cervical disk disease in patients who fail conservative treatment. i-FACTOR bone graft is a unique anorganic bone mineral (ABM) and small peptide, P-15™. P-15 is a synthetic fifteen amino acid polypeptide that mimics the cell-binding domain of Type I human collagen and is responsible for osteogenic cell attachment via alpha2-beta1 integrins.

This is randomized, controlled, multi-center, prospective FDA IDE study conducted to assess the safety and effectiveness of i-FACTOR bone graft (Cerapedics, Inc. Westminster, CO) in patients treated with single level ACDF. Patients received i-FACTOR bone graft or local autologous bone inside a structural allograft.

Conditions

Intervertebral Disk Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bone graft substitute

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

Group Type: EXPERIMENTAL

P-15 Synthetic osteoconductive bone substitute

Intervention Type: DEVICE

Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

Autologous Bone

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Group Type: ACTIVE_COMPARATOR

Autologous bone

Intervention Type: OTHER

Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring

Interventions

P-15 Synthetic osteoconductive bone substitute

Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

Intervention Type: DEVICE

Autologous bone

Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring

Intervention Type: OTHER

Other Intervention Names

i-Factor

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 65
• Radiographically determined discogenic origin to include at least one of the following characteristics: degenerated/dark disc on MRI, decreased disc height compared to adjacent levels on radiographic film, CT, or MRI and disc herniation on CT or MRI
• Radicular symptoms by history and physical exam to include at least the following characteristics: Arm/shoulder pain, decreased flexes, decreased strength and abnormal sensation
• Pain level arm/shoulder >4 on 0-10 VAS
• Pain level neck >4 on 0-10 VAS
• Neck disability Index >30
• Involved discs between C3 and C7
• Undergoing anterior cervical fusion at a single level
• Failed to gain adequate relief from non-operative treatment
• Able and willing to give consent to participate in study
• Understand and read English at elementary level

Exclusion Criteria

Systemic infection such as AIDS, HIV, and active hepatitis; Significant metabolic disease that in the surgeon's opinion might compromise bone growth such as osteoporosis or osteomalacia; Taking medication for the prevention of osteoporosis; Circulatory, cardiac, or pulmonary problems that could cause excessive surgical risk; Active malignancy; Nondiscogenic source of symptoms (e.g., tumor, etc.); Multiple level symptomatic degenerative disc disease; Previous cervical fusion; Previous cervical decompression at the same level; Acute cervical trauma or instability (i.e., subluxation > 3 mm on flexion/extension radiographic film); Undergoing treatment for tumor or bony traumatic injury to the cervical spine; Rheumatoid disease of the cervical spine; Myelopathy; Pregnant or planning to become pregnant in the next 2 years; Posterior cervical spine procedure scheduled; More than one level to be operated; Has a history of substance abuse (recreational drugs, alcohol); Is a prisoner; Is currently involved in a study of another investigational product for similar purpose; Has a disease process that would preclude accurate evaluation (e.g., neuromuscular disease, significant psychiatric disease).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CeraPedics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Janssen, MD / DO

Role: PRINCIPAL_INVESTIGATOR

Spine Education Research Institute

Locations

Department of Neurological Surgery UCSF Spine Center

San Francisco, California, United States

Spine Education Research Institute

Thornton, Colorado, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

Orthopaedics Northeast/Midwest Spine Group

Fort Wayne, Indiana, United States

Indiana Spine Group

Indianapolis, Indiana, United States

Indianapolis Neurosurgical Group

Indianapolis, Indiana, United States

Kansas University Medical Center

Kansas City, Kansas, United States

New England Neurosurgical Associates, LLC

Springfield, Massachusetts, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Utah Orthopaedic Center

Salt Lake City, Utah, United States

Foothills Medical Center

Calgary, Alberta, Canada

Montreal Neurological Institute

Montreal, Quebec, Canada

Countries

United States; Canada

References

Arnold PM, Vaccaro AR, Sasso RC, Goulet B, Fehlings MG, Heary RF, Janssen ME, Kopjar B. Six-Year Follow-up of a Randomized Controlled Trial of i-FACTOR Peptide-Enhanced Bone Graft Versus Local Autograft in Single-Level Anterior Cervical Discectomy and Fusion. Neurosurgery. 2023 Apr 1;92(4):725-733. doi: 10.1227/neu.0000000000002290. Epub 2022 Dec 23.

Reference Type: DERIVED

PMID: 36700705 (View on PubMed)

Other Identifiers

1003

Identifier Type: -

Identifier Source: org_study_id