An observational study in Bone Diseases, sponsored by Orthovita d/b/a Stryker. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-18.
Sponsored by Orthovita d/b/a Stryker · Observational
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.
261 studies on the registry are indexed under Bone Diseases; 49 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 101 observational studies indexed under Bone Diseases.
Browse Bone Diseases studies →Orthovita d/b/a Stryker is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be selected from retrospective records from the investigators specialty practice.
Exclusion Criteria:
Patients with a benign bone lesion of the extremity or pelvis for which surgical curettage age was recommended and who received Vitoss bone graft with BMA to fill the cavity.
Device: Vitoss
Patients with a benign bone lesion of the extremity or pelvis for which surgical curettage was recommended and who received Vitoss bone graft to fill the cavity.
Device: Vitoss
Vitoss is a synthetic calcium-based bone void filler made of beta-tricalcium phosphate.
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.
Time frame: minimum of 24 months post-operatively
This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Orthovita d/b/a Stryker