NCT05706909

Brief Summary

The purpose of this study is to assess the clinical and x-ray results of patients who are treated with core decompression of the hip and the injection of a bone marrow concentrate and the use of the Bone Graft Substitute Genex®.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
14mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Feb 2023Jul 2027

First Submitted

Initial submission to the registry

January 6, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

February 8, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

January 6, 2023

Last Update Submit

April 14, 2026

Conditions

Avascular NecrosisOsteonecrosis

Keywords

avascular necrosisosteonecorsishipfemoral head

Outcome Measures

Primary Outcomes (2)

  • Change from baseline X-ray result.

    Assessment of bone regeneration

    6 weeks, 12 weeks, 6 months, 12 months post operatively

  • Change from baseline MRI result.

    Assessment for no further collapse or progression of osteonecrosis

    12 months

Secondary Outcomes (4)

  • Numeric Pain Scale

    Baseline, 6 weeks, 12 weeks, 6 months, 12 months

  • Modified Harris Hip Score

    Baseline, 6 weeks, 12 weeks, 6 months, 12 months

  • Hip Outcome Score

    Baseline, 6 weeks, 12 weeks, 6 months, 12 months

  • EQ-5D-5L Score

    Baseline, 6 weeks, 12 weeks, 6 months, 12 months

Study Arms (1)

Genex with ABMC

Injection of autologous bone marrow concentrate and the use of genex® Bone graft Substitute as an adjunct associated with the Core decompression procedure

Device: Genex with ABMC

Interventions

Genex with ABMCDEVICE

Core decompression, injection of autologous bone marrow concentrate and the use of genex® Bone graft Substitute as an adjunct associated with the decompression procedure

Genex with ABMC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are 18 years or older with early osteonecrosis of the femoral head and meet the inclusion and exclusion criteria based on the protocol.

You may qualify if:

  • Subject is at least 18 years or older with osteonecrosis of the femoral head
  • Surgeon considers the patient appropriate for the core decompression procedure of the hip
  • Subject provides voluntarily signature on the IRB approved Informed Consent Form
  • Subject must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol and complete the study protocol and follow ups

You may not qualify if:

  • Subject is pregnant at the time of surgery
  • Subject is incarcerated
  • Subject is not comfortable with speaking, reading and understanding questions and providing responses in an available language for the questionnaires provided for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

  • Weinstein RS. Glucocorticoid-induced osteonecrosis. Endocrine. 2012 Apr;41(2):183-90. doi: 10.1007/s12020-011-9580-0. Epub 2011 Dec 15.

    PMID: 22169965BACKGROUND

  • Yang HL, Zhu XS, Chen L, Chen CM, Mangham DC, Coulton LA, Aiken SS. Bone healing response to a synthetic calcium sulfate/beta-tricalcium phosphate graft material in a sheep vertebral body defect model. J Biomed Mater Res B Appl Biomater. 2012 Oct;100(7):1911-21. doi: 10.1002/jbm.b.32758. Epub 2012 Jul 30.

    PMID: 22847979BACKGROUND

  • Moya-Angeler J, Gianakos AL, Villa JC, Ni A, Lane JM. Current concepts on osteonecrosis of the femoral head. World J Orthop. 2015 Sep 18;6(8):590-601. doi: 10.5312/wjo.v6.i8.590. eCollection 2015 Sep 18.

    PMID: 26396935RESULT

MeSH Terms

Conditions

Osteonecrosis

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas Piuzzi

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nicolas Piuzzi, M.D.

Study Record Dates

First Submitted

January 6, 2023

First Posted

January 31, 2023

Study Start

February 8, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)