Avascular Necrosis of the Femoral Head
Conditions
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.
Interventions
DEVICEPerFuse Percutaneous Decompression System
Core decompression with PerFuse
DEVICEBioCUE Platelet Concentration System
PRP injection through the PerFuse cannula into core decompression site
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | 12 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Second procedure | 5 years (all time points) | Number of patients receiving a second study procedure |
| Hips with no lesion size change | 12 months | Number of hips with no change or reduction in lesion size |
| Adverse Events | 5 years (all time points) | Number of adverse events |
| Incidence of invasive non-study procedures in the hip | 5 years (all time points) | Number of hip requiring an non-study invasive procedure |
| EQ-5D-3L | 5 years (all time points) | Change in European Quality of Life 5 Dimensions 3 Levels score |
| NRS Pain | 5 years (all time points) | Change in Numeric Rating Scale for Pain score |
| Harris Hip Score | 5 years (all time points) | number of patients with Good or Excellent scores |
Countries
United States
Outcome results
None listed