- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01491542
INFUSE® Bone Graft and MASTERGRAFT® Granules With CD HORIZON® for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease - Pilot Study
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
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Autogenous bone
|
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 Names:
|
Experimental: rhBMP-2 / ACS
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Success
Time Frame: 24 months
|
A patient will be considered an overall success if all of the following conditions are met:
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
General Health Status (SF-36)
Time Frame: 24 months
|
24 months
|
Pain Status (back pain, leg pain)
Time Frame: 24 months
|
24 months
|
Patient Satisfaction
Time Frame: 24 months
|
24 months
|
Patient Global Perceived Effect
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P01-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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