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Biologically Assisted Core Decompression of the Femoral Head Using the PerFuse Instrument and BioCUE (REGP-44-00)

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ClinicalTrials.gov Identifier: NCT02662881
Recruitment Status : Enrolling by invitation
First Posted : January 26, 2016
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment
Avascular Necrosis of the Femoral Head Device: PerFuse Percutaneous Decompression System Device: BioCUE Platelet Concentration System

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Post-Market Data Collection for Biologically Assisted Core Decompression of the Femoral Head Using the PerFuse Instrument and BioCUE
Actual Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2023

Intervention Details:
  • Device: PerFuse Percutaneous Decompression System
    Core decompression with PerFuse
  • Device: BioCUE Platelet Concentration System
    PRP injection through the PerFuse cannula into core decompression site


Primary Outcome Measures :
  1. Harris Hip Score [ Time Frame: 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 Outcome Measures :
  1. Incidence of invasive non-study procedures in the hip [ Time Frame: 5 years (all time points) ]
    Number of hip requiring an non-study invasive procedure

  2. Second procedure [ Time Frame: 5 years (all time points) ]
    Number of patients receiving a second study procedure

  3. Hips with no lesion size change [ Time Frame: 12 months ]
    Number of hips with no change or reduction in lesion size

  4. Adverse Events [ Time Frame: 5 years (all time points) ]
    Number of adverse events

  5. Harris Hip Score [ Time Frame: 5 years (all time points) ]
    number of patients with "Good" or "Excellent" scores

  6. Quality of Life [ Time Frame: 5 years (all time points) ]
    Change in European Quality of Life 5 Dimensions 3 Levels score

  7. Pain [ Time Frame: 5 years (all time points) ]
    Change in Numeric Rating Scale for Pain score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662881


Locations
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
University of Pennsylvania/ Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Wisconsin
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Zimmer Biomet

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02662881     History of Changes
Other Study ID Numbers: BBIO.CR.BIOAVN.002.15
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Necrosis
Femur Head Necrosis
Pathologic Processes
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases