Evaluation of Vitoss With and Without BMA for Benign Cavitary Lesions

Status unconfirmed

Conditions studied: Bone Diseases

In brief

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.

Key facts

Study ID

NCT02165943

Run by

Orthovita d/b/a Stryker

People needed

100

Starts

2014-01-01

Expected to finish

2014-12-01

Last updated by the study team

2014-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Upstate Orthopedics, LLC — Syracuse, New York, United States

Full record on ClinicalTrials.gov

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