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

Sponsors and Collaborators:	AO Clinical Investigation and Documentation CeraPedics, Inc
Information provided by:	AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:	NCT00310440

Purpose

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

Condition	Intervention	Phase
Degenerative Disc Disease (DDD) Decompresion of Spine Root	Device: Synthetic osteoconductive bone substitute	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation

Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:

The difference in the fusion rates at twelve months between the investigational device and the control group will be greater than -ten [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The difference in average neck disability index values at twelve months between the investigational device and the control group will be greater than eleven points. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Difference in pain (arm) measured by VAS at twelve months between the investigational and the control group will be greater than 1,8 points [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Difference in pain (neck) measured by VAS at twelve months between the investigational and the control group will be greater than 1.8 points [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Kyphosis rates at twelve months will not differ between the experimental and the control group [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Standardized SF-36 and composite scores (PCS and MCS) values at twelve months will not differ between the experimental and the control group [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Success rates measured by aggregated modified Odom's criteria at twelve months will differ between the experimental and the control group [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complication rates at twelve months will differ between the experimental and the control group [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	204
Study Start Date:	January 2006
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 strenght 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 infections such as HIV, Aids and active hepatitis
significant metabolic disease that in the surgeons mind may compromise bone growth such as osteoporosis or osteomalacia
Taking medication for the prevention of osteoporosis
Circulatory, cardiac or pulmonary problems that can cause excessive surgical risk
active malignancy
nondiscogenic source of symptoms (e.g. tumor,..)
multiple level symptomatic degenerative disc disease
previous cervical fusion
previous cervical decompression at the same level
acute cervical trauma or instability
undergoing treatment for tumor or bony traumatic injury to the cervical spine
rheumatoid disease of the cervical spine
myelopathy
pregnancy or planning to become pregnant in the next 2 years
posterior cervical spine procedure scheduled
more than one level to be operated
no history of substance abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310440

Locations

United States, Colorado
Spine Education Research Institute	Recruiting
Thornton, Colorado, United States, 80228
Contact: Michael Janssen, MD, DO 720-540-7374 janssenm@spine-education.org
Principal Investigator: Michael Janssen, MD, DO

Sponsors and Collaborators

AO Clinical Investigation and Documentation

CeraPedics, Inc

Investigators

Principal Investigator:

Michael Janssen, MD / DO

Spine Education Research Institute

More Information

No publications provided

Responsible Party:	CeraPedics, Inc. ( Andy Handwerker )
Study ID Numbers:	06-P15-04
Study First Received:	April 3, 2006
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00310440 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AO Clinical Investigation and Documentation:

Degenerative disc disease
P-15 Bone Putty
Bone replacement material

Cervical discectomy
Loss of foraminal area
neural compression

Study placed in the following topic categories:

Spinal Diseases
Musculoskeletal Diseases
Bone Diseases

Additional relevant MeSH terms:

Spinal Diseases
Musculoskeletal Diseases
Bone Diseases

ClinicalTrials.gov processed this record on May 07, 2009