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

Zimmer Biomet100 enrolled

Overview

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. The study will evaluate change in Harris Hip Score (HHS) at 12 months after treatment. The change in AVN lesion size will also be measured at 12 months after index treatment via MRI. Change in quality of life and pain measures will be measured at each follow-up. Adverse events will also be recorded throughout the study. This study will follow patients for 5 years after initial treatment. Data will be recorded in a online database that will be entered by the site or patient, depending on the report form. This database includes data checks to compare entered data against predefined rules for range. A risk-based monitoring plan will be put in place for source data verification.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Avascular Necrosis of the Femoral Head

Interventions

PerFuse Percutaneous Decompression SystemDEVICE

Core decompression with PerFuse

BioCUE Platelet Concentration SystemDEVICE

PRP injection through the PerFuse cannula into core decompression site

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (4)

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

Outcomes

Primary Outcomes

Harris Hip Score

Percentage of patients achieving clinical success at 12 month follow up, being defined as a 20 point increase in the Harris Hip Score from baseline

Time frame: 12 month