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Comparison of Actifuse ABX and Local Bone in Spinal Surgery

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ClinicalTrials.gov Identifier: NCT01852747
Recruitment Status : Terminated (The sponsor merged with another company and decided they did not want to continue with the study.)
First Posted : May 14, 2013
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Safdar Khan, Ohio State University

Tracking Information
First Submitted Date  ICMJE April 30, 2013
First Posted Date  ICMJE May 14, 2013
Last Update Posted Date April 28, 2017
Study Start Date  ICMJE March 2013
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
Decrease patient recovery time [ Time Frame: 12 months ]
The investigators anticipate the Actifuse ABX® will decrease patient recovery time by 1) lowering the amount of autologous bone harvested from the patient and 2) taking advantage of the properties of Actifuse (osteostimulation, resorption rate, etc) that should result in quicker bone fusing and healing.
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
Decrease patient recovery time [ Time Frame: 12 months ]
We anticipate the Actifuse ABX® will decrease patient recovery time by 1) lowering the amount of autologous bone harvested from the patient and 2) taking advantage of the properties of Actifuse (osteostimulation, resorption rate, etc) that should result in quicker bone fusing and healing.
Change History Complete list of historical versions of study NCT01852747 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Actifuse ABX and Local Bone in Spinal Surgery
Official Title  ICMJE Actifuse ABX and Local Bone Have Comparable Outcomes to Local Bone in Instrumented Multi-Level Adult Spinal Deformity Patients
Brief Summary This study is being done to compare people who had a standard of care spinal fusion using part of their local bone graft (a small amount of bone from the region of the spine where the fusion is occurring) to correct an adult spinal deformity and people who will have a standard of care spinal fusion using a mixture of Actifuse ABX® (a market approved bone graft substitute) and a local bone graft (a small amount of bone from the region of the spine where the fusion is occurring). This study will compare the outcomes of both groups to help the Orthopaedic surgeon conducting spinal fusions in the future. Investigators expect that Actifuse ABX® will be as good if not better than just a local bone graft.
Detailed Description

The current method for posterolateral lumbar fusion surgeries utilizes autograft bone typically derived from the patient's iliac crest. However, complications have been reported concerning the use of iliac crest bone, that include additional healing time due to the secondary surgical site and gait abnormalities. Clinicians are in need of an adequate alternative, and many have begun testing growth factors or synthetic compounds used in conjunction with local bone autografts. Though this avoids the need for a secondary surgical site, synthetic materials are not without their own limitations. These compounds must achieve similar growth and fusion rates as native bone. This study will test the applicability of Actifuse, a synthetic bone graft substitute, in instrumented multi-level adult spinal deformity surgery.

Actifuse is a silicate substituted calcium phosphate. It is osteostimulative, and is a bone void filler intended for orthopedic applications such as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse has several features that mimic human bone (amount of silicon, resorption rate, etc). It provides a scaffold for long-term bone healing and is intended to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, pelvis and spine including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that is resorbed and replaced by native bone during the healing process.

Actifuse accelerates bone growth by combining an interconnected macro- and micro- porous structure with osteostimulative chemistry created through a patented silicate substitution process to attach and stimulate osteoprogenitor cells (OPCs) and mesenchymal stem cells (MSCs). It resists irrigation and can be easily viewed on x-rays to monitor healing. Previous groups have shown that Actifuse is successful in the laboratory as well as in patients; however, previously reported literature has not studied the efficacy of Actifuse in instrumented multi-level adult spinal deformity.

Based on previous literature, investigators expect the Actifuse ABX to successfully fuse to native bone growth and promote fusion as well as an autograft replacement. Potential pitfalls include Actifuse not functioning as well in place of native bone. If this occurs, investigators will conduct revision surgery to ensure proper bone union.

The success of this project could have significant effects for the society at large. It is estimate that over 200,000 arthrodeses are performed each year, and the autologous iliac crest bone graft is often considered the standard of care, therefore these results could improve the outcome of surgery for thousands of patients every year. In addition, it will likely cut down on time the surgeon is in the operating room. It could also speed patient recovery by 1) lowering the amount of autologous bone harvested from the patient, and 2) taking advantage of the properties of Actifuse (osteostimulation, resorption rate, etc) that should result in quicker bone fusing and healing.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Scoliosis
  • Kyphosis
  • Lordosis
Intervention  ICMJE Procedure: Multilevel Spinal fusion with Actifuse ABX®
Multilevel spinal fusion as treatment for adult spinal deformity with Actifuse ABX®. Actifuse ABX® is a silicate substituted calcium phosphate bone void filler intended for orthopedic applications such as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
Study Arms  ICMJE
  • Experimental: Multilevel Spinal Fusion w/ Actifuse ABX®
    An osteostimulatory,phase pure,porous,silicate substituted calcium phosphate bone graft substitute used during multilevel spinal fusion.
    Intervention: Procedure: Multilevel Spinal fusion with Actifuse ABX®
  • No Intervention: Multilevel Spinal Fusion
    Multilevel spinal fusion without Actifuse ABX.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 26, 2017)
14
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2013)
60
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient aged 18 to 80
  • Patient received primary diagnosis of adult spinal deformity (with fusion of >2 levels)
  • Patient is a candidate for multi-level posterior lumbar fusion
  • Patients that do not meet any of the exclusion criteria

Exclusion Criteria:

  • Non-English speaker
  • Current Smoker
  • Prisoner
  • Patient with any of the following:

Severe degenerative disease Inflammatory bone disease (e.g. osteomyelitis) Metabolic bone disease Radiation bone therapy Existing acute or chronic infections Abnormal calcium metabolism Hypocalcaemia Severe vascular or neurological disease Cardiovascular disease precluding elective surgery Uncontrolled diabetes Severely impaired renal function Documented renal disease Malignant tumors Pregnant or nursing

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01852747
Other Study ID Numbers  ICMJE 2013H0023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Safdar Khan, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE Baxter Healthcare Corporation
Investigators  ICMJE
Principal Investigator: Safdar Khan, MD Ohio State University
PRS Account Ohio State University
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP