INFUSE® Bone Graft and MASTERGRAFT® Granules With CD HORIZON® for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease - Pilot Study

Tracking Information
First Submitted Date ICMJE	December 12, 2011
First Posted Date ICMJE	December 14, 2011
Last Update Posted Date	August 2, 2013
Study Start Date ICMJE	April 2003
Actual Primary Completion Date	November 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 13, 2011)	Overall Success [ Time Frame: 24 months ]; A patient will be considered an overall success if all of the following conditions are met: Fusion;; Postoperative Oswestry score improvement of at least 15% from preoperative;; Maintenance or improvement in neurological status;; No serious adverse event classified as implant associated or implant surgical procedure associated;; No additional surgical procedure classified as a "failure".
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01491542 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 13, 2011)	General Health Status (SF-36) [ Time Frame: 24 months ]; Pain Status (back pain, leg pain) [ Time Frame: 24 months ]; Patient Satisfaction [ Time Frame: 24 months ]; Patient Global Perceived Effect [ Time Frame: 24 months ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	INFUSE® Bone Graft and MASTERGRAFT® Granules With CD HORIZON® for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease - Pilot Study
Official Title ICMJE	A Pilot Prospective Randomized Clinical Investigation of INFUSE® Bone Graft and MASTERGRAFT® Granules With the CD HORIZON® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic Degenerative Disc Disease
Brief Summary	The purpose of this pilot clinical trial is to evaluate the feasibility of using the investigational implant (INFUSE® Bone Graft and MASTERGRAFT® Granules with the CD HORIZON® Spinal System) as a method of facilitating spinal fusion in patients with symptomatic degenerative disc disease.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Degenerative Disc Disease
Intervention ICMJE	Device: INFUSE® Bone Graft/MASTERGRAFT® Granules/CD HORIZON® The INFUSE® Bone Graft component of the investigational device consists of recombinant human Bone Morphogenetic Protein-2(rhBMP-2) and an absorbable collagen sponge (ACS)carrier. The MASTERGRAFT® Granules will be used as a type of bulking agent to provide compression resistance. Other Names: Infused Bone Graft MasterGraft; Device: Autogenous Bone / CD HORIZON® Spinal System The control will be autogenous bone taken from the iliac crest of the patient and placed bilaterally across two adjacent transverse processes and used in conjunction with the CD HORIZON® Spinal System. Other Name: Autograft
Study Arms	Experimental: rhBMP-2 / ACS Intervention: Device: INFUSE® Bone Graft/MASTERGRAFT® Granules/CD HORIZON®; Active Comparator: Autogenous bone Intervention: Device: Autogenous Bone / CD HORIZON® Spinal System
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	Completed
Actual Enrollment ICMJE; (submitted: December 13, 2011)	46
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	March 2007
Actual Primary Completion Date	November 2006 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history (e.g., pain [leg, back, or symptoms in the sciatic nerve distribution], functional deficit and/or neurological deficit) and radiographic studies (e.g.,C T, MRl, X-Ray,etc.) to include one or more of the following: instability (defined as angulation ≥ 5° and/or translation ≥ 4mm,based on flexion/extension radiographs); osteophyte formation; decreased disc height; thickening of ligamentous tissue; disc degeneration or herniation; and/or facet joint degeneration.; Has preoperative Oswestry score ≥ 30.; Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW,1932).; Requires fusion of a single level disc space from L1 to S1.; Is at least 18 years of age, inclusive, at the time of surgery.; Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of 6 months.; If of child-bearing potential, patient is non-pregnant,non-nursing,and agrees to use adequate contraception for 1 year following surgery.; Is willing and able to comply with the study plan and sign the Patient Informed Consent Form. Exclusion Criteria: Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level.; Had previous spinal fusion surgical procedure at the involved level or an adjacent level.; Requires spinal fusion at more than one lumbar level.; Has a condition which requires postoperative medications that interfere with fusion, such as steroids or prolonged use of nonsteroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.; Has a documented history of osteopenia or osteomalacia.; Has any of the following that may be associated with diagnosis of osteoporosis (if "Yes" to any of the below risk factors,a dual x-ray absorptiometry (DEXA) scan will be required to determine eligibility.) Postmenopausal non-black female over 60 years of age and weighs less than 140 pounds. Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture. Male over the age of 70. Male over the age of 60 that has sustained a non-traumatic hip or spine fracture. If the level of BMD is a T score of -3.5 or a T score of -2.5 with vertebral crush fracture,then the patient is excluded from the study.; Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).; Has overt or active bacterial infection, either local or systemic.; Has a documented titanium alloy allergy or intolerance.; Is mentally incompetent. If questionable, obtain psychiatric consult.; Has a 'Waddell Signs of Inorganic Behavior'score of 3 or greater.; Is a prisoner.; Is an alcohol and/or drug abuser as defined by currently undergoing treatment or alcohol and/or drug abuse.; ls a tobacco user at the time of surgery.; Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate).; Has a documented history of autoimmune disease ( e.g. Systemic Lupus Erythematosus or dermatomyositis).; Has a history of exposure to implanted collagen or silicone implants.; Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.; Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/ACS/MASTERGRAFT® Granules implantation.; Has received any previous exposure to any/all BMP's of either human or animal extraction.; Has a history of allergy to bovine products or a history of anaphylaxis.; Has a history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease,renal osteodystrophy, Ehlers- Danlos syndrome,or osteogenesis imperfecta).
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01491542
Other Study ID Numbers ICMJE	P01-11
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Medtronic Spinal and Biologics
Study Sponsor ICMJE	Medtronic Spinal and Biologics
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Medtronic Spinal and Biologics
Verification Date	December 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP