This is a retrospective, two-arm study reviewing the healing of cavitary defects in patients treated with Vitoss alone versus those treated with Vitoss with bone marrow aspirate (BMA). There will be a prospective follow-up visit at 24+ months to evaluate lont-term healing in patients identified during the retrospective portion of the study. It is thought that the inclusion of BMA will facilitate the resorption of the graft material, leading to better long-term bone healing.
Study Type
OBSERVATIONAL
Enrollment
100
Vitoss is a synthetic calcium-based bone void filler made of beta-tricalcium phosphate.
Upstate Orthopedics, LLC
Syracuse, New York, United States
Percentage of Vitoss resorption into the native bone as observed via CT
Percentage of Vitoss resorption into the native bone will be retrospectively recorded in the Case Report Form at the 6 week, 3, 6, 12 and 18 month timepoints based on review of x-rays as well.
Time frame: minimum of 24 months post-operatively
Presence of graft within the soft tissue as observed by CT
Presence of the graft within the soft tissue will be retrospectively recorded in the Case Report Form at the 6 week, 3, 6, 12 and 18 month timepoints based on review of x-rays as well.
Time frame: minimum of 24 months post-operatively
Presence of a rim of radiolucency surrounding the grafted defect as observed by CT
Presence of a rim of radiolucency surrounding the grafted defect will be retrospectively recorded in the Case Report Form at the 6 week, 3, 6, 12 and 18 month timepoints based on review of x-rays as well.
Time frame: minimum of 24 months post-operatively
Size of the defect as observed by CT
The size of the defect will be retrospectively recorded in the Case Report Form at the 6 week, 3, 6, 12 and 18 month timepoints based on review of x-rays as well.
Time frame: minimum of 24 months post-operatively
Bone trabeculation through the defect as observed by CT
Bone trabeculation through the defect will be retrospectively recorded in the Case Report Form at the 6 week, 3, 6, 12 and 18 month timepoints based on review of x-rays as well.
Time frame: minimum of 24 months post-operatively
Persistence of graft material through the lesion as observed by CT
Persistence of graft material through the lesion will be retrospectively recorded in the Case Report Form at the 6 week, 3, 6, 12 and 18 month timepoints based on review of x-rays as well.
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Time frame: minimum of 24 months post-operatively