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

Study Overview
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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.

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

Conditions
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Avascular Necrosis of the Femoral Head

Intervention / Treatment
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* Device: PerFuse Percutaneous Decompression System
* Device: BioCUE Platelet Concentration System


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PerFuse Percutaneous Decompression System|Core decompression with PerFuse|
|Device: BioCUE Platelet Concentration System|PRP injection through the PerFuse cannula into core decompression site|

What is the study measuring?
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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) |