Biologically Assisted Core Decompression of the Femoral Head Using the PerFuse Instrument and BioCUE

Status unconfirmed

Conditions studied: Avascular Necrosis of the Femoral Head

In brief

This study will evaluate the performance of biologically assisted core decompression with the PerFuse instrument and BioCUE in patients with bone lesions in the femoral head. The study will explore the potential impact of patient demographics and baseline characteristics on post-operative outcomes.

Key facts

Study ID

NCT02662881

Run by

Zimmer Biomet

People needed

100

Starts

2016-03-01

Expected to finish

2021-12-01

Last updated by the study team

2021-10-20

Who can join

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

You may qualify if…

• Willing and able to comply with the study procedures
• Signed informed consent
• Untreated unilateral or bilateral bone lesion(s) of the femoral head associated with AVN in need of biologically assisted core decompression. Note:If bilateral untreated bone lesions of the femoral head associated with AVN,both hips eligible and willing to undergo study treatment and follow-up
• ≥ 3 months after arthroplasty (e.g., total, hemi) in the contralateral hip

You may not qualify if…

• Pregnant or lactating
• Participating in another device or drug study
• ARCO stage ≥ III
• Unable to undergo MRI of the study hip(s)
• Active, local or systemic infection

Where it is running

• Washington University in St. Louis — St Louis, Missouri, United States
• Cleveland Clinic Foundation - Orthopaedic and Rheumatologic Institute — Cleveland, Ohio, United States
• University of Pennsylvania/ Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Medical College Of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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