A prospective, multi-center study evaluating allograft tissue as a bone void filler when implanted with Lenoss Medical manual surgical instrumentation in patients with painful vertebral compression fractures.
Vertebral compression fractures can be associated with instability and severe, persistent pain and limitation of activities. This post market study is being conducted to assess fracture stability over time.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Use allograft tissue in patients with one or two level, thoracic or lumbar T6-L5, vertebral compression fractures.
Lenoss Medical manual surgical access and cavity creation instruments will be used when implanting the allograft tissue.
University of Colorado Denver | Anschutz Medical Campus
Denver, Colorado, United States
RECRUITINGNorth Shore University Hospital
Manhasset, New York, United States
RECRUITINGMount Sinai
New York, New York, United States
Evaluate fracture stability assessed via subject- reported pain over time
Subject-reported pain over time using the allograft tissue will be assessed using the Visual Analog Scale (VAS) for back pain on a scale of 0mm (no pain) to 100mm (worst pain imaginable).
Time frame: 12 months
Measure of Physical Disability Assessed via the Roland Morris Disability Questionnaire
The Roland Morris Disability Questionnaire is a widely used health status measure for physical disability caused by low back pain. Scores range from 0 to 24 with higher scores representing higher levels of pain-related disability.
Time frame: 12 months
Measurement of Quality of Life Assessed via the EuroQol Health Outcome Instrument (EQ-5D-3L)
The EQ-5D-3L is a standardized instrument used as a measure of health outcomes. It contains questions in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and provides a simple descriptive profile and single index for health status preference. In addition, there is a Visual Analog Scale (VAS). The VAS is the participant's rating of their health on a scale of 0 "worst imaginable health state" to 100 "best imaginable health state".
Time frame: 12 months
Measurement of Activities of Daily Living Assessed via the Modified Tegner Activity Level Scale
The Modified Tegner Activity Level Scale is designed to measure a patient's activities of daily living, recreation, and competitive sports. The scale includes an assessment of level of activity pre- and post- injury. The scores range from 0 to 10 with a 0 representing sick leave or disability.
Time frame: 12 months
Frequency of Implant Related Complications
The frequency of allograft tissue related complications will be tabulated. Intra-operative complications, surgical time, and any other significant adverse events will be summarized as safety variables. Adverse events will be tabulated by physician's assessment of seriousness, severity, expectedness, the event's causative relation to the allograft tissue or the Access and Cavity Creation instruments, and by elapsed time since surgery. Adverse events that require secondary surgical intervention (SSI) will be flagged.
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Montefiore Medical Center
The Bronx, New York, United States
RECRUITINGClinical Investigations LLC
Edmond, Oklahoma, United States
ACTIVE_NOT_RECRUITINGTime frame: 12 months