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

Post-Market Data Collection for Biologically Assisted Core Decompression of the Femoral Head Using the PerFuse Instrument and BioCUE

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Avascular Necrosis of the Femoral Head
• Intervention / Treatment: Device: PerFuse Percutaneous Decompression System; Device: BioCUE Platelet Concentration System

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation - Orthopaedic and Rheumatologic Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • University of Pennsylvania/ Pennsylvania Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects with untreated unilateral or bilateral bone lesion(s) of the femoral head associated with AVN in need of biologically assisted core decompression.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Christopher Travers, MD, Trustees of the University of Pennsylvania; Principal Investigator: Cecilia Pasucal-Garrido, MD, Washington University School of Medicine; Principal Investigator: Joseph Schwab, MD, Medical College of Wisconsin; Principal Investigator: Nicolas Piuzzi, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): December 8, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 18, 2016
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (Estimate): January 26, 2016

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis
• Other Study ID Numbers: BBIO.CR.BIOAVN.002.15