Evaluation of Vitoss With and Without BMA for Benign Cavitary Lesions

• Conditions: Bone Diseases
• Interventions: Device: Vitoss

• Registration Number: NCT02165943
• Lead Sponsor: Orthovita d/b/a Stryker

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-05-30
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-12
• Last Update Submitted: 2014-06-12
• Study First Posted: 2014-06-18
• Last Update Posted: 2014-06-18
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vitoss Bone Graft with BMA	Vitoss	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.
Vitoss bone graft	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Upstate Orthopedics, LLC; 🇺🇸 Syracuse, New York, United States