Phase
Condition
Spondylolisthesis
Ankylosing Spondylitis
Treatment
NanoBone
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The individual has signed and dated a study specific informed consent form approvedby the Institutional Review Board at UMMHC.
The individual is 18 to 85 years of age.
The individual is skeletally mature.
The individual has been diagnosed with 1 or 2 level degenerative disc disease orspondylolisthesis grade 1-3 with or without spinal stenosis, requiringposterolateral spinal fusion surgery with bone grafting.
The individual is physically and mentally willing and able to comply with thepostoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion
Exclusion Criteria:
The individual has had any previous attempts at fusion, at any lumbar levels.
The individual is morbidly obese (defined as 100 lbs over the recommended idealweight as described in the Metropolitan Life Height and Weight Tables for Men andWomen and or having a BMI >39).
Patients with osteopenia, osteoporosis, or osteomalacia to a degree that spinalinstrumentation would be contraindicated.
Patients with systemic collagen, bone or mineralization dysfunction (such as Paget'sdisease, osteogenesis imperfecta, Ehlers-Danlos Syndrome).
Patients who suffer from uncontrolled diabetes mellitus type I or insulin-dependentdiabetes mellitus type II. (definition based on the glycosylated Haemoglobin level)
Patients who are suffering from autoimmune disease.
Patients who previously underwent chemotherapy, immunosuppressive disease orradiation to the local area.
Patients who received or are currently receiving corticosteroids (> 2 years > 5 mgprednisolone equivalent/d).
Patients with active local or systemic infection.
Patients with any known active malignancy.
Patients with other concurrent physical or mental conditions which are likely toaffect their outcome.
Patient unable to consent for themselves
Pregnant women
Non-English speaking subjects. These subjects are excluded because they would not beable to complete the English-language surveys required during this study. OnlyEnglish language versions of these surveys have been validated.
Prisoners
Patients less than 18 years old
Study Design
Study Description
Connect with a study center
UMass Memorial Health Care
Worcester, Massachusetts 01605
United StatesSite Not Available
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