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

NCT00310440 | Completed Results DMC

• 1 other identifier: 1003
• Study Type: interventional
• Target: 319
• Locations: 2 countries
• Sites: 12

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..

Conditions

Intervertebral Disk Degeneration

Keywords

Degenerative disc disease; P-15 Bone Putty; Bone graft; Cervical discectomy; Cervical spine

Outcome Measures

Primary Outcomes (4)

• Radiologic Fusion

  Successful fusion was based on roentgenographic examination showing: evidence of bridging trabecular bone between the involved motion segments, translational motion \<3mm, and angular motion \<5 degrees. If there was a lack of evidence of fusion on 12 month plain x-ray examination, a CT-scan was performed and final determination of the fusion status was made using the CT reading. The criteria for fusion on CT scans were: trabecular bone formation patterns within the intervertebral disc space and bridging bone formation that crosses the interspace.

  12 months

• Change in of the Overall Neck Disability Index (NDI) Score From Baseline.

  The NDI consists of ten items addressing functional activities (personal care, lifting, reading, work, driving, sleeping, recreational activities), pain intensity, concentration and headache. For each item, there are six potential responses, describing increasing degrees of disability (no disability = 0 to total disability = 5). An overall NDI score, out of 100, is calculated by adding up the scores for each item and multiplying by two. A higher NDI score indicates greater disability.

  12 months

• Neurologic Success

  The neurological endpoint is a binary variable. Neurologic success was assessed in the motor, sensory and reflex domains specific for the cervical spine as follows: maintenance or improvement of motor function in the elbow flexors (i.e. biceps muscle), elbow extensors (i.e. triceps muscle) and wrist extensors of both arms; maintenance or improvement of sensory function of both arms; maintenance or improvement of reflexes of both arms as measured at biceps tendon, triceps tendon and brachioradialis (supinator) reflex AND absence of Babinski reflex (if not present prior to surgery). Worsening of neurological status (neurological failure) was defined as a permanent decline in the subject's neurological status based on adjudication of accumulated neurological data by an independent blinded evaluator.

  12 months

• Complications

  Any AE within 12 months of surgery.

  12 months

Secondary Outcomes (6)

• Mean Change in Pain at Neck Visual Analog Scale (VAS).

  Baseline and 12 months

• Mean Change at Pain at Arm and Shoulder Visual Analog Scale (VAS).

  Baseline and 12 months

• Success Rates Measured by Aggregated Modified Odom's Criteria

  12 months

• Mean Change in the Short Form 36 v2 (SF-36v2) Physical Composite Score (PCS).

  Baseline and 12 months

• Mean Change in the Short Form 36 v2 (SF-36v2) Mental Health Composite Score (MCS).

  Baseline and 12 months

Study Arms (2)

Bone graft substitute

EXPERIMENTAL

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).

Device: P-15 Synthetic osteoconductive bone substitute

Autologous Bone

ACTIVE COMPARATOR

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.

Other: Autologous bone

Interventions

P-15 Synthetic osteoconductive bone substitute DEVICE

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

Also known as: i-Factor

Bone graft substitute

Autologous bone OTHER

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

Autologous Bone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• CeraPedics, Inc: lead

Study Sites (12)

Department of Neurological Surgery UCSF Spine Center

San Francisco, California, 94143, United States

Location

Spine Education Research Institute

Thornton, Colorado, 80229, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34233, United States

Location

Orthopaedics Northeast/Midwest Spine Group

Fort Wayne, Indiana, 46825, United States

Location

Indiana Spine Group

Indianapolis, Indiana, 46260, United States

Location

Indianapolis Neurosurgical Group

Indianapolis, Indiana, 46260, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160-0001, United States

Location

New England Neurosurgical Associates, LLC

Springfield, Massachusetts, 01104, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

Location

Montreal Neurological Institute

Montreal, Quebec, H3A 2B4, Canada

Location

Related Publications (1)

• 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.

  PMID: 36700705 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Lead Clinical Research Associate
• Organization: Nor Consult, LLC

p15@nor-consult.com

2066076861

Study Officials

• Michael Janssen, MD / DO

  Spine Education Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2006
• First Posted: April 4, 2006
• Study Start: January 1, 2006
• Primary Completion: May 1, 2014
• Study Completion: May 23, 2019
• Last Updated: March 12, 2020
• Results First Posted: February 10, 2016

Record last verified: 2020-03

Locations

US (10); CA (2)