Early Feasibility Study of Cartilage Defect Repair

Launched by CYTEX THERAPEUTICS, INC. · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to repair damaged cartilage in the hip joint for people suffering from conditions like osteoarthritis or hip injuries. The study aims to find out if a specific implant can help those who are between 14 and 55 years old and have not found relief from standard treatments like pain medications or physical therapy. To qualify for the study, participants must have certain criteria, including clear evidence of cartilage loss in their hip, a body mass index (BMI) of less than 35, and have experienced hip pain for at least three months.

If you or someone you know is interested in this trial, it's important to know that participants will need to complete a consent form and be available for follow-up for up to five years after the surgery. The trial is not currently recruiting participants, but it will eventually involve individuals who meet the eligibility requirements and are willing to contribute to the study's goals. The trial excludes those with significant health issues, recent infections, or certain conditions that could interfere with the surgery or recovery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. At least 14 years of age to no older than 55 years of age Subjects 14-21 years of age must have radiographic evidence of epiphyseal closure in the hip joint
• • 2. BMI \< 35
• • 3. Failed at least 6 weeks of conservative treatment (e.g., anti-inflammatory pain medications, physical therapy, injections)
• • 4. Duration of symptoms consistent with intra-articular disease (i.e., groin, lateral and/or posterior hip pain) that have persisted for at least 3 months
• • 5. Loss of articular cartilage integrity (\~1 - 6 cm\^2 in area) on the femoral head (confirmed by MRI), without an opposing lesion that can be treated with a single ReNew Hip Implant
• • 6. Radiographic assessment with joint space width \> 2 mm (verified by x-ray)
• • 7. Meets an acceptable preoperative medical clearance and is free of conditions that would pose excessive operative risk, in the opinion of the investigator
• • 8. Given consent to participate in the study
• 9. Able to understand the purpose of the study, his/her role, and is available for follow-up with a 2-year extension:
• • 1. Subject has signed an IRB (Institutional Review Board) approved Informed Consent Form agreeing to participate in the extension study after the nature, scope, and possible consequences of the study have been explained in an understandable form
• • 2. Subject is able to fully understand the purpose of the study, his/her role as a participant in the study, and plans to be available through five years post-operative follow-up
• Exclusion Criteria:
• • 1. Smoker (\< 1 month cessation of smoking)
• • 2. Type 1 or Type 2 Diabetes
• • 3. Systemic Steroid use in past 3 months
• • 4. Coxa plana, coxa magna, or proximal femoral focal deficiency on the femoral head
• • 5. Any acute or chronic condition that would limit the ability of the patient to participate in the study (e.g., COPD, congestive heart failure),
• • 6. Bleeding disorders
• • 7. Current cancer (with the exception of non-melanoma skin cancer)
• • 8. Pregnancy or planning to become pregnant during the study period
• • 9. Active infection or sepsis
• • 10. History of local hip infection
• • 11. Known metastatic or neoplastic disease
• • 12. Conditions that may interfere with implant survival or outcomes (e.g., severe dysplasia)
• • 13. Life expectancy less than 2 years
• • 14. Intra-articular therapy within 3 months of enrollment
• • 15. Inadequate bone stock (as determined by SCORE or MORES assessment) to support the device
• 16. Femoral head is:
• • 1. outside of the 46 - 56 mm range in either anteroposterior diameter or lateral diameters or
• • 2. an aspherical head deformity
• • 17. Moderate to severe renal insufficiency
• • 18. Emotional or neurological condition that would preempt ability or willingness to participate in the study
• • 19. Above the knee amputation of the contralateral or ipsilateral leg
• • 20. Known allergies to the components of the device (polycaprolactone)
• • 21. Is a prisoner