Bone Diseases
Conditions
Brief summary
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.
Interventions
DEVICEVitoss
Vitoss is a synthetic calcium-based bone void filler made of beta-tricalcium phosphate.
Sponsors
Orthovita d/b/a Stryker
Study design
Observational model
CASE_CONTROL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Vitoss resorption into the native bone as observed via CT | minimum of 24 months post-operatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of graft within the soft tissue as observed by CT | minimum of 24 months post-operatively | 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. |
| Presence of a rim of radiolucency surrounding the grafted defect as observed by CT | minimum of 24 months post-operatively | 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. |
| Size of the defect as observed by CT | minimum of 24 months post-operatively | 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. |
| Bone trabeculation through the defect as observed by CT | minimum of 24 months post-operatively | 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. |
| Persistence of graft material through the lesion as observed by CT | minimum of 24 months post-operatively | 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. |
Countries
United States
Outcome results
None listed