Biologically Assisted Core Decompression of the Femoral Head Using the PerFuse Instrument and BioCUE (REGP-44-00)

Zimmer Biomet

Status: Active, not recruiting

Conditions: Avascular Necrosis of the Femoral Head

Treatments: Device: PerFuse Percutaneous Decompression System; Device: BioCUE Platelet Concentration System

Study type: Observational

Funder types: Industry

Identifiers

NCT02662881

BBIO.CR.BIOAVN.002.15

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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