NCT02662881

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Avascular Necrosis of the Femoral Head

Interventions

Type	Name	Description
DEVICE	PerFuse Percutaneous Decompression System	Core decompression with PerFuse
DEVICE	BioCUE Platelet Concentration System	PRP injection through the PerFuse cannula into core decompression site

Timeline

• Start date: 2016-03-01
• Primary completion: 2020-12-08
• Completion: 2021-12-01
• First posted: 2016-01-26
• Last updated: 2021-10-20

Locations

4 sites across 1 country: United States