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

NCT ID: NCT02662881

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Avascular Necrosis of the Femoral Head

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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PerFuse Percutaneous Decompression System

Core decompression with PerFuse

Intervention Type DEVICE

BioCUE Platelet Concentration System

PRP injection through the PerFuse cannula into core decompression site

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Travers, MD

Role: PRINCIPAL_INVESTIGATOR

Trustees of the University of Pennsylvania

Cecilia Pasucal-Garrido, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Joseph Schwab, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Nicolas Piuzzi, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Cleveland Clinic Foundation - Orthopaedic and Rheumatologic Institute

Cleveland, Ohio, United States

Site Status

University of Pennsylvania/ Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status

Medical College Of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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BBIO.CR.BIOAVN.002.15

Identifier Type: -

Identifier Source: org_study_id