Evaluation of Vitoss With and Without BMA for Benign Cavitary Lesions

Orthovita

Status: Unknown

Conditions: Bone Diseases

Treatments: Device: Vitoss

Study type: Observational

Funder types: Industry

Identifiers

NCT02165943

1101-0014

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Vitoss Bone Graft with BMA

Description:

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.

Treatment:

Device: Vitoss

Vitoss bone graft

Description:

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.

Treatment:

Device: Vitoss