A Pilot Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
|ClinicalTrials.gov Identifier: NCT01494428|
Recruitment Status : Completed
First Posted : December 19, 2011
Last Update Posted : August 2, 2013
Medtronic Spinal and Biologics
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
The purpose of this pilot clinical trial is to evaluate the device design as a method of facilitating spinal fusion.
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease||Device: rhBMP-2/ACS/allograft bone dowel Device: Autogenous bone/allograft bone dowel||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease|
|Study Start Date :||April 1998|
|Actual Primary Completion Date :||February 2004|
|Actual Study Completion Date :||February 2004|
Device: rhBMP-2/ACS/allograft bone dowel
The rhBMP-2/ACS will be used in conjunction with an allograft bone dowel.
Other Name: Recombinant human bone morphogenetic protein-2
|Active Comparator: Autogenous Bone||
Device: Autogenous bone/allograft bone dowel
An allograft bone dowel contains autogenous bone taken from the patient's iliac crest.
Other Name: Autograft
Primary Outcome Measures :
- Severity and Rate of Implant-Associated Adverse Events [ Time Frame: 24 month ]
- Rate of Implant Revision, Removal and Supplemental Fixation Procedures [ Time Frame: 24 month ]
- Incidence of Permanent Adverse Events [ Time Frame: 24 month ]
- Fusion [ Time Frame: 24 month ]
Fusion is defined as:
- Bone observed connecting with the vertebral bodies above and below either through the implants; lateral to or between the implants; or anterior/posterior to the implants.
- Angulation < 5°.
- Translation < 3mm.
- Absence of radiolucent lines around more than 50% of either implant.
- Disc Height Measurement [ Time Frame: 24 month ]Disc height will be measured postoperative and compared to the preoperative measurement. Maintenance or improvement in disc height will be determined a success.
- Pain/Disability Status [ Time Frame: 24 month ]The self-administered Oswestry Low Back Pain Disability Questionnaire will be used. Success will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score >= 15
- Neurological Status [ Time Frame: 24 month ]Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale.
Secondary Outcome Measures :
- Nature and Frequency of Adverse Events Not Associated with the Implants [ Time Frame: 24 month ]
- Rate of Reoperation Procedures [ Time Frame: 24 month ]
- Hip (Donor Site) Pain Status [ Time Frame: 24 month ]
- Patient Satisfaction/Quality of Life Status (SF-36) [ Time Frame: 24 month ]
- Pain Status (Numerical Rating Scale) [ Time Frame: 24 month ]
- Overall Success [ Time Frame: 24 months ]
A patient will be considered an overall success if all of the following conditions are met:
- disc height maintenance or improvement
- pain/disability (Oswestry) improvement
- maintenance or improvement in neurological status
- no permanent adverse event
- no additional surgical procedure classified as a "failure."
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