Slow enrollment
A Prospective Study Assessing Clinical Outcomes and Radiographic Results After the Use of CopiOs(R) Bone Void Filler (BVF)Sponge in a Posterolateral Fusion Procedure (PLF).
Sponsor study identifier
interventional
45
1 country
6
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)To compare radiographic data collection from patients undergoing instrumented PLF with CopiOs(R) BVF or instrumented PLF with autologous bone and to assess overall clinical outcomes. Patients will serve as self controls.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 12, 2010
Actual (reported)May 14, 2010
Actual (reported)June 2010
Date type not reportedThis date has not been verified as actual or estimated.
October 2012
Actual (reported)October 2012
Actual (reported)May 27, 2015
Actual (reported)Fusion Assessment
Fusion at 12M using radiograph Fusion Mass at 12M using CT
6 M, 12 M
Outcome Measure - Pain, Life Quality, Satisfaction
PreOp, Surgery, 6M, 12M
All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.
Bone Void Filler
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Florida Hospital
Orlando, Florida, 32803, United States
Neurological Surgery of Southern Illinois
Belleville, Illinois, 62226, United States
Indiana Orthopedic Center
Indianapolis, Indiana, 46250, United States
Las Cruces Orthopaedic Associates
Las Cruces, New Mexico, 88005, United States
Upstate Bone and Joint Center
East Syracuse, New York, 13057, United States
Scott and White Healthcare
Temple, Texas, 76508, United States
45 participants (actual enrollment reported by the registry).
First Submitted
May 12, 2010
First Posted
May 14, 2010
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
Contact the study team to confirm eligibility.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)Last Updated
May 27, 2015
Results First Posted
May 27, 2015
Record last verified: 2015-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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