Early Feasibility Study of Cartilage Defect Repair

Summary

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.

Eligibility

Inclusion Criteria:

1. At least 14 years of age to no older than 64 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 for the duration of the study:

   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. Current users of nicotine in any form (e.g., cigarettes, e- cigarettes/vaping, chewing tobacco, nicotine patches, gum, lozenges), or individuals who have discontinued nicotine use less than 30 days prior to screening.
2. Type 1 or Type 2 Diabetes
3. Systemic steroid use in the 3 months prior to screening
4. Coxa plana, coxa magna, or proximal femoral focal deficiency on the femoral head that would result in implant mismatch of the femoral head contour
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 that results in contour mismatch of 16a
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

Conditions10

Locations1 site

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