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

• Conditions: Avascular Necrosis of the Femoral Head

• Registration Number: NCT02662881
• Lead Sponsor: Zimmer Biomet

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-26
• Study Start: 2016-03
• Primary Completion: 2020-12-08
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-20
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Harris Hip Score	12 month	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

Secondary Outcome Measures

Name	Time	Method
Hips with no lesion size change	12 months	Number of hips with no change or reduction in lesion size
Incidence of invasive non-study procedures in the hip	5 years (all time points)	Number of hip requiring an non-study invasive procedure
Second procedure	5 years (all time points)	Number of patients receiving a second study procedure
Harris Hip Score	5 years (all time points)	number of patients with "Good" or "Excellent" scores
EQ-5D-3L	5 years (all time points)	Change in European Quality of Life 5 Dimensions 3 Levels score
NRS Pain	5 years (all time points)	Change in Numeric Rating Scale for Pain score
Adverse Events	5 years (all time points)	Number of adverse events

Trial Locations

Locations (4)

Cleveland Clinic Foundation - Orthopaedic and Rheumatologic Institute; 🇺🇸 Cleveland, Ohio, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Medical College Of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University of Pennsylvania/ Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States