Actively Recruiting
Early Feasibility Study of Cartilage Defect Repair
Led by Cytex Therapeutics, Inc. · Updated on 2026-02-17
15
Participants Needed
1
Research Sites
307 weeks
Total Duration
On this page
Sponsors
C
Cytex Therapeutics, Inc.
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Any patient aged 14 or older up to 64 years of age with hip disease, resulting in loss of articular cartilage integrity on the femoral head (e.g., femoroacetabular impingement or other structural deformity), has failed conservative care, and is a candidate for surgical intervention to treat.
CONDITIONS
Official Title
Early Feasibility Study of Cartilage Defect Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 14 and 64 years (subjects 14-21 years must have hip growth plate closure confirmed by X-ray)
- Body mass index (BMI) below 35
- Failed at least 6 weeks of conservative treatment such as anti-inflammatory medications, physical therapy, or injections
- Hip pain consistent with intra-articular disease lasting at least 3 months
- Loss of articular cartilage integrity on the femoral head between approximately 1 and 6 cm squared, confirmed by MRI, treatable with one ReNew Hip Implant
- Hip joint space width greater than 2 mm confirmed by X-ray
- Medically cleared for surgery without excessive operative risk
- Provided informed consent and able to understand the study and commit to follow-up for up to five years after surgery
You will not qualify if you...
- Current use of nicotine or nicotine products or stopped less than 30 days before screening
- Diagnosis of Type 1 or Type 2 diabetes
- Use of systemic steroids in the 3 months before screening
- Femoral head deformities such as coxa plana, coxa magna, or proximal femoral focal deficiency causing implant mismatch
- Any acute or chronic condition limiting participation (e.g., COPD, heart failure)
- Bleeding disorders
- Active cancer except non-melanoma skin cancer
- Pregnancy or planning pregnancy during the study
- Active infection or sepsis
- History of local hip infection
- Known metastatic or neoplastic disease
- Conditions affecting implant survival (e.g., severe dysplasia)
- Life expectancy under 2 years
- Intra-articular therapy within 3 months before enrollment
- Inadequate bone stock for device support
- Femoral head size outside 46-56 mm range or aspherical deformity causing mismatch
- Moderate to severe kidney failure
- Emotional or neurological conditions affecting study participation
- Above knee amputation of either leg
- Known allergy to device components (polycaprolactone)
- Prisoner status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
B
Brad Estes, PhD
CONTACT
C
Christine Estes
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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