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

Avascular Necrosis of the Femoral Head Clinical Trial

— REGP-44-00  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02662881
• Other study ID #: BBIO.CR.BIOAVN.002.15
• Status: Active, not recruiting
• Start date: March 2016
• Est. completion date: December 2021

Study information

• Verified date: October 2021
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: December 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Avascular Necrosis of the Femoral Head
• Necrosis

Intervention

Device:
• PerFuse Percutaneous Decompression System
Core decompression with PerFuse
• BioCUE Platelet Concentration System
PRP injection through the PerFuse cannula into core decompression site

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation - Orthopaedic and Rheumatologic Institute	Cleveland	Ohio
United States	Medical College Of Wisconsin	Milwaukee	Wisconsin
United States	University of Pennsylvania/ Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

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