Clinical trial NCT02662881: Biologically Assisted Core Decompression of the Femoral Head Using the PerFuse Instrument and BioCUE
Official title: Post-Market Data Collection for Biologically Assisted Core Decompression of the Femoral Head Using the PerFuse Instrument and BioCUE
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Avascular Necrosis of the Femoral Head
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2016-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Harris Hip Score
timeFrame: 12 month
Secondary outcomes:
measure: Incidence of invasive non-study procedures in the hip
timeFrame: 5 years (all time points)
measure: Second procedure
timeFrame: 5 years (all time points)
measure: Hips with no lesion size change
timeFrame: 12 months
measure: Adverse Events
timeFrame: 5 years (all time points)
measure: Harris Hip Score
timeFrame: 5 years (all time points)
measure: EQ-5D-3L
timeFrame: 5 years (all time points)
measure: NRS Pain
timeFrame: 5 years (all time points)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation - Orthopaedic and Rheumatologic Institute
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania/ Pennsylvania Hospital
state: Pennsylvania
city: Milwaukee
country: United States
facility: Medical College Of Wisconsin
state: Wisconsin
Study officials:
affiliation: Trustees of the University of Pennsylvania
name: Christopher Travers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Cecilia Pasucal-Garrido, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Joseph Schwab, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Nicolas Piuzzi, MD
role: PRINCIPAL_INVESTIGATOR
References: