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

Avascular Necrosis Clinical Trial

— Genex  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05706909
• Other study ID #: 22-580
• Status: Recruiting
• Start date: February 8, 2023
• Est. completion date: July 2027

Study information

• Verified date: April 2024
• Source: The Cleveland Clinic
• Contact: Alison Klika
• Phone: 216-444-4954
• Email: klikaa[@]ccf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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®.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2027
• Est. primary completion date: February 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Avascular Necrosis
• Necrosis
• Osteonecrosis

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Biocomposites Ltd

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline X-ray result.	Assessment of bone regeneration	6 weeks, 12 weeks, 6 months, 12 months post operatively
Primary	Change from baseline MRI result.	Assessment for no further collapse or progression of osteonecrosis	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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