INFUSE® Bone Graft and MASTERGRAFT® Granules With CD HORIZON® for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease - Pilot Study
- Conditions
- Degenerative Disc Disease
- Interventions
- Device: INFUSE® Bone Graft/MASTERGRAFT® Granules/CD HORIZON®Device: Autogenous Bone / CD HORIZON® Spinal System
- Registration Number
- NCT01491542
- Lead Sponsor
- Medtronic Spinal and Biologics
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
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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.
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Has preoperative Oswestry score ≥ 30.
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Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW,1932).
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Requires fusion of a single level disc space from L1 to S1.
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Is at least 18 years of age, inclusive, at the time of surgery.
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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.
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If of child-bearing potential, patient is non-pregnant,non-nursing,and agrees to use adequate contraception for 1 year following surgery.
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Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.
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Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level.
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Had previous spinal fusion surgical procedure at the involved level or an adjacent level.
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Requires spinal fusion at more than one lumbar level.
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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.
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Has a documented history of osteopenia or osteomalacia.
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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.
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Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
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Has overt or active bacterial infection, either local or systemic.
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Has a documented titanium alloy allergy or intolerance.
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Is mentally incompetent. If questionable, obtain psychiatric consult.
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Has a 'Waddell Signs of Inorganic Behavior'score of 3 or greater.
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Is a prisoner.
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Is an alcohol and/or drug abuser as defined by currently undergoing treatment or alcohol and/or drug abuse.
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ls a tobacco user at the time of surgery.
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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).
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Has a documented history of autoimmune disease ( e.g. Systemic Lupus Erythematosus or dermatomyositis).
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Has a history of exposure to implanted collagen or silicone implants.
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Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
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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.
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Has received any previous exposure to any/all BMP's of either human or animal extraction.
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Has a history of allergy to bovine products or a history of anaphylaxis.
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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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rhBMP-2 / ACS INFUSE® Bone Graft/MASTERGRAFT® Granules/CD HORIZON® - Autogenous bone Autogenous Bone / CD HORIZON® Spinal System -
- Primary Outcome Measures
Name Time Method Overall Success 24 months A patient will be considered an overall success if all of the following conditions are met:
1. Fusion;
2. Postoperative Oswestry score improvement of at least 15% from preoperative;
3. Maintenance or improvement in neurological status;
4. No serious adverse event classified as implant associated or implant surgical procedure associated;
5. No additional surgical procedure classified as a "failure".
- Secondary Outcome Measures
Name Time Method General Health Status (SF-36) 24 months Patient Global Perceived Effect 24 months Patient Satisfaction 24 months Pain Status (back pain, leg pain) 24 months