The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral Head (Genex)

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®.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteonecrosis; Avascular Necrosis
• Intervention / Treatment: Device: Genex with ABMC

Detailed Description

Avascular necrosis (AVN) or osteonecrosis (ON) of the femoral head refers to a condition in bone metabolism when cells of the trabecular bone (porous bone found at the end of long bones like the femur) in the hip spontaneously die. Depending on the amount of femoral head involvement, parts of the surface, like the articular surface that do not have blood vessels may collapse as the disease advances. Although the exact common occurrence of AVN or ON is unknown, the incidence is estimated to be between 20,000 to 30,000 newly diagnosed patients each year in the US.

Core decompression of the hip is a minimally invasive surgical technique performed to manage symptoms in early stages (precollapse) of the condition. The procedure involves drilling holes into the femoral head to relieve pressure and create channels for new blood vessels to nourish the affected areas. Multiple adjuncts to core decompression, such as structural bone grafts, bone marrow concentrates, and bone proteins have been developed to accelerate the healing process in these patients. In recent years, considerable research activity has also been expanded to find new bone substitutes with osteoconductive properties (where bone grows on a surface) for the use in the treatment of surgically created defects.

Genex® Bone Graft Substitute is a catalyst for bone healing. It complements the body's natural healing processes and encourages normal bone structure to be restored at a steady rate. Over 12 months, the graft matrix is completely absorbed and replaced by bone. No foreign artifacts are left behind to impair structural integrity.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Core decompression, injection of autologous bone marrow concentrate and the use of genex® Bone graft Substitute as an adjunct associated with the decompression procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Scale	To assess pain using the Numeric Pain Scale on a scale of 0-10 with 10 being the worst possible pain report and 0 being no pain	Baseline, 6 weeks, 12 weeks, 6 months, 12 months
Modified Harris Hip Score	To evaluate the success of the core decompression procedure using the Modified Harris Hip Score by adding up the assigned points for each question, divided by a maximum score of (91) x 100 to create a percentage. A higher score equals a higher level of physical function (100% = full function).	Baseline, 6 weeks, 12 weeks, 6 months, 12 months
Hip Outcome Score	To assess the outcome of the treatment intervention using the Hip Outcome Score with five possible responses, graded from 0 to 4 with 4 being no difficulty at all and 0 unable to do in regard to physical limitations.	Baseline, 6 weeks, 12 weeks, 6 months, 12 months
EQ-5D-5L Score	To assess aspects of mobility, self-care, usual activities, pain/discomfort and anxiety/depression using the EQ-5D-5L tool. The EQ-5D-5L descriptive system uses (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems', and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression).	Baseline, 6 weeks, 12 weeks, 6 months, 12 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Biocomposites Ltd
• Investigators: Principal Investigator: Nicolas Piuzzi, The Cleveland Clinic

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: hip; avascular necrosis; femoral head; osteonecorsis
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Necrosis; Pathological Conditions, Signs and Symptoms; Osteonecrosis
• Other Study ID Numbers: 22-580

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No