Recruiting

Observational Study

Sponsor:

Cytex Therapeutics, Inc.

Code:

NCT06823089

Conditions

Osteoarthritis, Hip

Femoroacetabular Impingement

Osteonecrosis

Legg-Calvé-Perthes Disease

Osteochondral Lesion

Eligibility Criteria

Sex: All

Age: 14 - 64

Healthy Volunteers: Not accepted

Interventions

ReNew Hip Implant

Study Details

Brief 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.

Conditions

Osteoarthritis, Hip

Femoroacetabular Impingement

Osteonecrosis

Legg-Calvé-Perthes Disease

Osteochondral Lesion

Study ID

NCT06823089

Start date

Nov 6, 2025

Status verified date

Feb, 2026

Completion date

Oct, 2031

Anticipated

Primary completion date

Oct, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 64

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Investigational Arm

The investigation device for this study will be the ReNew Hip Implant.

Interventions

ReNew Hip Implant

Surgical Intervention

Primary outcome measure

  • To establish initial safety (adverse events and device related serious adverse events) and effectiveness (pain and function) of the ReNew Hip Implant [ Time Frame: 6, 12, and 60 months ]
  • The international Hip Outcome Tool-33 (iHOT-33) [ Time Frame: 6, 12, and 60 months ]

Central Contacts and Locations

Central contacts

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Jeffrey Nepple, MD

More Information

Sponsor

Cytex Therapeutics, Inc.

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • articular cartilage
  • hip resurfacing
  • residual Perthes disease
  • post-Perthes deformity
  • femoral head deformity
  • secondary hip osteoarthritis
  • hip preservation surgery
  • adolescent hip deformity
  • adult hip deformity
  • avascular necrosis of femoral head
  • early-stage avascular necrosis
  • Perthes sequelae
  • traumatic femoral head lesion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cytex Therapeutics, Inc. on 2026-02-17.