Evaluation of Vitoss With and Without BMA for Benign Cavitary Lesions

Study Overview
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Brief Summary
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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.

Official Title
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A Combined Retrospective and Prospective Protocol to Evaluate Vitoss With and Without Bone Marrow Aspirate for Benign Cavitary Lesions

Conditions
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Bone Diseases

Intervention / Treatment
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* Device: Vitoss


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: males and females >/= 18 years of age at the time of surgery Patients treated with Vitoss alone or Vitoss with added BMA between 2004 and 2012 willing and able to provide Informed Consent to participate in and follow study requirements (including a radiologic assessment) Exclusion Criteria: Patients with a known post-traumatic defect active infection at the time of implantation history of bone marrow disorders contraindications to the use of supplemental BMA

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vitoss Bone Graft with BMA<br>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<br>* Vitoss is a synthetic calcium-based bone void filler made of beta-tricalcium phosphate.<br>|
| Vitoss bone graft<br>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<br>* Vitoss is a synthetic calcium-based bone void filler made of beta-tricalcium phosphate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | minimum of 24 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | minimum of 24 months post-operatively |