Comparison of Actifuse ABX and Local Bone in Spinal Surgery

NCT01852747 | Terminated Phase 4

• 1 other identifier: 2013H0023
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis; Kyphosis; Lordosis

Keywords

Spinal Deformity; Multilevel; Posterior; Lumbar; Fusion; Levoscoliosis; Dextroscoliosis; Graft

Outcome Measures

Primary Outcomes (1)

• Decrease patient recovery time

  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.

  12 months

Study Arms (2)

Multilevel Spinal Fusion w/ Actifuse ABX®

EXPERIMENTAL

An osteostimulatory,phase pure,porous,silicate substituted calcium phosphate bone graft substitute used during multilevel spinal fusion.

Procedure: Multilevel Spinal fusion with Actifuse ABX®

Multilevel Spinal Fusion

NO INTERVENTION

Multilevel spinal fusion without Actifuse ABX.

Interventions

Multilevel Spinal fusion with Actifuse ABX® PROCEDURE

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.

Multilevel Spinal Fusion w/ Actifuse ABX®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43203, United States

Location

MeSH Terms

Conditions

Scoliosis; Kyphosis; Lordosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Safdar Khan, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Safdar Khan, MD

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 14, 2013
• Study Start: March 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 28, 2017

Record last verified: 2014-02

Locations

US (1)