Early Feasibility Study of Cartilage Defect Repair

NCT06823089 | Recruiting FDA Device

• 1 other identifier: CIP-0001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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; Hip Dysplasia

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

Outcome Measures

Primary Outcomes (2)

• To establish initial safety (adverse events and device related serious adverse events) and effectiveness (pain and function) of the ReNew Hip Implant

  Incidence rate of all adverse events including general adverse events, procedure related events and device related events. Incidence rate of device-related serious adverse events

  6, 12, and 60 months

• The international Hip Outcome Tool-33 (iHOT-33)

  Difference demonstrated between pre-op and post-op iHOT-33

  6, 12, and 60 months

Secondary Outcomes (7)

• Radiographic

  6, 12, and 60 months

• Kaplan Meier survivorship

  12, 24, and 60 months post-surgery

• Patient Reported Outcome Measures

  6, 12, 24, and 60 months post-surgery

• Health economic outcomes

  Time Frame: Intra-operative

• Health economic outcomes

  Time Frame: Hospital admission to discharge

Study Arms (1)

Investigational Arm

EXPERIMENTAL

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

Device: ReNew Hip Implant

Interventions

ReNew Hip Implant DEVICE

Surgical Intervention

Investigational Arm

Eligibility Criteria

• Age: 14 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• BMI \< 35
• Failed at least 6 weeks of conservative treatment (e.g., anti-inflammatory pain medications, physical therapy, injections)
• 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)
• 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
• Radiographic assessment with joint space width \> 2 mm (verified by x-ray)
• Meets an acceptable preoperative medical clearance and is free of conditions that would pose excessive operative risk, in the opinion of the investigator
• Given consent to participate in the study
• Able to understand the purpose of the study, his/her role, and is available for follow-up for the duration of the study:
• 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
• 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

You may not qualify if:

• 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.
• Type 1 or Type 2 Diabetes
• Systemic steroid use in the 3 months prior to screening
• Coxa plana, coxa magna, or proximal femoral focal deficiency on the femoral head that would result in implant mismatch of the femoral head contour
• Any acute or chronic condition that would limit the ability of the patient to participate in the study (e.g., COPD, congestive heart failure),
• Bleeding disorders
• Current cancer (with the exception of non-melanoma skin cancer)
• Pregnancy or planning to become pregnant during the study period
• Active infection or sepsis
• History of local hip infection
• Known metastatic or neoplastic disease
• Conditions that may interfere with implant survival or outcomes (e.g., severe dysplasia)
• Life expectancy less than 2 years
• Intra-articular therapy within 3 months of enrollment
• Inadequate bone stock (as determined by SCORE or MORES assessment) to support the device

Sponsors & Collaborators

• Cytex Therapeutics, Inc.: lead
• MCRA: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (2)

• Roemer FW, Hunter DJ, Winterstein A, Li L, Kim YJ, Cibere J, Mamisch TC, Guermazi A. Hip Osteoarthritis MRI Scoring System (HOAMS): reliability and associations with radiographic and clinical findings. Osteoarthritis Cartilage. 2011 Aug;19(8):946-62. doi: 10.1016/j.joca.2011.04.003. Epub 2011 Apr 20.

  PMID: 21550411 BACKGROUND

• Gold SL, Burge AJ, Potter HG. MRI of hip cartilage: joint morphology, structure, and composition. Clin Orthop Relat Res. 2012 Dec;470(12):3321-31. doi: 10.1007/s11999-012-2403-7.

  PMID: 22723242 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip; Femoracetabular Impingement; Osteonecrosis; Legg-Calve-Perthes Disease; Hip Dislocation; Coxa Magna; Femur Head Necrosis

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases; Necrosis; Joint Dislocations; Wounds and Injuries; Hip Injuries

Central Study Contacts

Brad Estes, PhD

CONTACT

919.912.9839; info@cytexortho.com

Christine Estes

CONTACT

cestes@cytexortho.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, non-randomized, non-comparative, single-arm, open-label, multicenter, clinical study

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 12, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2031
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)