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

NCT02662881 | Unknown

• 1 other identifier: BBIO.CR.BIOAVN.002.15
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Avascular Necrosis of the Femoral Head

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence of invasive non-study procedures in the hip

  5 years (all time points)

• Second procedure

  5 years (all time points)

• Hips with no lesion size change

  12 months

• Adverse Events

  5 years (all time points)

• Harris Hip Score

  5 years (all time points)

Interventions

PerFuse Percutaneous Decompression System DEVICE

Core decompression with PerFuse

BioCUE Platelet Concentration System DEVICE

PRP injection through the PerFuse cannula into core decompression site

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (4)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Cleveland Clinic Foundation - Orthopaedic and Rheumatologic Institute

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania/ Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Medical College Of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Femur Head Necrosis

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 26, 2016
• Study Start: March 1, 2016
• Primary Completion: December 8, 2020
• Study Completion: December 1, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Locations

US (4)