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

Sponsor
Zimmer Biomet (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02662881
Collaborator
(none)
100
Enrollment
4
Locations
69
Anticipated Duration (Months)
25
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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 :
Mar 1, 2016
Actual Primary Completion Date :
Dec 8, 2020
Anticipated Study Completion Date :
Dec 1, 2021

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Incidence of invasive non-study procedures in the hip [5 years (all time points)]

    Number of hip requiring an non-study invasive procedure

  2. Second procedure [5 years (all time points)]

    Number of patients receiving a second study procedure

  3. Hips with no lesion size change [12 months]

    Number of hips with no change or reduction in lesion size

  4. Adverse Events [5 years (all time points)]

    Number of adverse events

  5. Harris Hip Score [5 years (all time points)]

    number of patients with "Good" or "Excellent" scores

  6. EQ-5D-3L [5 years (all time points)]

    Change in European Quality of Life 5 Dimensions 3 Levels score

  7. NRS Pain [5 years (all time points)]

    Change in Numeric Rating Scale for Pain score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University in St. Louis Saint Louis Missouri United States 63110
2 Cleveland Clinic Foundation - Orthopaedic and Rheumatologic Institute Cleveland Ohio United States 44195
3 University of Pennsylvania/ Pennsylvania Hospital Philadelphia Pennsylvania United States 19107
4 Medical College Of Wisconsin Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • Zimmer Biomet

Investigators

  • Principal Investigator: Christopher Travers, MD, Trustees of the University of Pennsylvania
  • Principal Investigator: Cecilia Pasucal-Garrido, MD, Washington University School of Medicine
  • Principal Investigator: Joseph Schwab, MD, Medical College of Wisconsin
  • Principal Investigator: Nicolas Piuzzi, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT02662881
Other Study ID Numbers:
  • BBIO.CR.BIOAVN.002.15
First Posted:
Jan 26, 2016
Last Update Posted:
Oct 20, 2021
Last Verified:
Oct 1, 2021
Additional relevant MeSH terms:
Necrosis

Study Results

No Results Posted as of Oct 20, 2021