Avascular Necrosis of the Femoral HeadREGP-44-00NCT02662881

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

An observational study of Avascular Necrosis of the Femoral Head, run by Zimmer Biomet at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Avascular Necrosis of the Femoral Head
What is being tested?: PerFuse Percutaneous Decompression System and BioCUE Platelet Concentration System
Type of treatment: Injection or infusion, Medical device
How many people: 100 participants
Where: 4 sitesUnited States
Study dates: Mar 2016to Dec 2021
How long will I take part?: 5 Years
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Cleveland Clinic Foundation - Orthopaedic and Rheumatologic Institute
Cleveland, Ohio, 44195
Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226
University of Pennsylvania/ Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Washington University in St. Louis
St Louis, Missouri, 63110

Other trials in United States

About this study

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

Read the 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
Being tested: PerFuse Percutaneous Decompression System, BioCUE Platelet Concentration System
Medical subject headings: Femur Head Necrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PerFuse Percutaneous Decompression SystemDevice
Core decompression with PerFuse
BioCUE Platelet Concentration SystemDevice
PRP injection through the PerFuse cannula into core decompression site

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 12 month

Secondary outcomes (7)

Incidence of invasive non-study procedures in the hip
Number of hip requiring an non-study invasive procedure
Measured: 5 years (all time points)
Second procedure
Number of patients receiving a second study procedure
Measured: 5 years (all time points)
Hips with no lesion size change
Number of hips with no change or reduction in lesion size
Measured: 12 months
Adverse Events
Number of adverse events
Measured: 5 years (all time points)
Harris Hip Score
number of patients with "Good" or "Excellent" scores
Measured: 5 years (all time points)
EQ-5D-3L
Change in European Quality of Life 5 Dimensions 3 Levels score
Measured: 5 years (all time points)
NRS Pain
Change in Numeric Rating Scale for Pain score
Measured: 5 years (all time points)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Dec 2021

First posted26 Jan 2016 (estimated)
Study startMar 2016
Primary completion8 Dec 2020
Study completionDec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Avascular Necrosis of the Femoral HeadStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 100 participants (estimated)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT02662881
Sponsor's protocol ID: BBIO.CR.BIOAVN.002.15
Acronym: REGP-44-00
Status last verified: Oct 2021
First submitted: 18 Jan 2016
Last updated: 20 Oct 2021
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Osteoarthritis, Traumatic Arthritis
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruiting
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
Primary Osteoarthritis, Cartilage Degeneration
Active, not recruiting
Avenir Complete Post-Market Clinical Follow-Up Study
Osteoarthritis, Hip, Avascular Necrosis of Hip
Active, not recruitingObservational study
The Medacta Quadra-P Anteverted Study
Arthrosis, Traumatic Arthritis

All Avascular Necrosis of the Femoral Head trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Market Data Collection for Biologically Assisted Core Decompression of the Femoral Head Using the PerFuse Instrument and BioCUE
ClinicalTrials.gov ID: NCT02662881
Acronym / sponsor ID: REGP-44-00 / BBIO.CR.BIOAVN.002.15
Conditions: Avascular Necrosis of the Femoral Head
Study type: Observational
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: Mar 2016 (actual)
Primary completion: 8 Dec 2020 (actual)
Study completion: Dec 2021 (estimated)
First posted: 26 Jan 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study will follow patients for 5 years after initial treatment.

A risk-based monitoring plan will be put in place for source data verification.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 5 Years

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PerFuse Percutaneous Decompression SystemCore decompression with PerFuse	Device	–
BioCUE Platelet Concentration SystemPRP injection through the PerFuse cannula into core decompression site	Device	–

Primary outcome

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

7 secondary outcomes

Incidence of invasive non-study procedures in the hip
Time frame: 5 years (all time points)
Second procedure
Time frame: 5 years (all time points)
Hips with no lesion size change
Time frame: 12 months
Adverse Events
Time frame: 5 years (all time points)
Harris Hip Score
Time frame: 5 years (all time points)
EQ-5D-3L
Time frame: 5 years (all time points)
NRS Pain
Time frame: 5 years (all time points)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.

Related trials for Avascular Necrosis of the Femoral Head

Recruiting
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Osteoarthritis, Traumatic Arthritis
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruiting
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
Primary Osteoarthritis, Cartilage Degeneration
Active, not recruiting
Avenir Complete Post-Market Clinical Follow-Up Study
Osteoarthritis, Hip, Avascular Necrosis of Hip
Active, not recruitingObservational study
The Medacta Quadra-P Anteverted Study
Arthrosis, Traumatic Arthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christopher Travers, MD principal investigator

Trustees of the University of Pennsylvania

Cecilia Pasucal-Garrido, MD principal investigator

Washington University School of Medicine

Joseph Schwab, MD principal investigator

Medical College of Wisconsin

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Avascular Necrosis of the Femoral Head, run by Zimmer Biomet at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Harris Hip Score (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02662881.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.