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Osteoarthritis, HipNCT06823089

Early Feasibility Study of Cartilage Defect Repair

A study testing ReNew Hip Implant in people with Osteoarthritis, Hip and Femoroacetabular Impingement, run by Cytex Therapeutics, Inc. at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 64 years
What is being tested?
ReNew Hip Implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
6 Nov 2025to Oct 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 64 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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
  • Femoral head is:
  • outside of the 46 - 56 mm range in either anteroposterior diameter or lateral diameters or
  • an aspherical head deformity that results in contour mismatch of 16a
  • Moderate to severe renal insufficiency
  • Emotional or neurological condition that would preempt ability or willingness to participate in the study
  • Above the knee amputation of the contralateral or ipsilateral leg
  • Known allergies to the components of the device (polycaprolactone)
  • Is a prisoner

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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.

Read the detailed description

When patients suffer from arthritis in the hip joint and fail conservative treatment, the standard surgical approach is total joint arthroplasty, where the joint is entirely removed and replaced with artificial materials. While this procedure is suitable for less active or older individuals, it is not ideal for younger, more active patients. Despite this, the number of total hip replacements in younger patients is increasing, requiring significant lifestyle adjustments to extend the implant's lifespan. Even with these efforts, most patients will face at least one total joint revision in their lifetime, each carrying an increased risk of complications and decreased patient satisfaction. As a result, total hip replacements are generally not recommended for patients aged 40 to 65 who experience activity-limiting symptoms and have exhausted conservative treatments.

The Cytex device offers an alternative treatment option for this patient population - those suffering from hip osteoarthritis (OA), unresponsive to conservative care, yet considered too young or active for total joint replacement. Notably, the Cytex implant preserves all pre-existing healthy bone stock, unlike traditional total hip resurfacing or arthroplasty procedures, allowing for future revision to conventional resurfacing or arthroplasty if needed.

The investigational device for this study, the ReNew Hip Implant, is a bioabsorbable, highly porous implant designed with mechanical properties that closely mimic those of healthy articular cartilage. The implant features a bicomponent structure, combining a biomimetic 3D woven textile with a porous 3D-printed framework.

Being tested
ReNew Hip Implant
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
Medical subject headings
Osteoarthritis, Hip, Femoracetabular Impingement, Osteonecrosis, Legg-Calve-Perthes Disease, Hip Dislocation, Coxa Magna, Femur Head Necrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReNew Hip ImplantDevice

    Surgical Intervention

Study groups in NCT06823089
Study groupRoleWhat they receive
Investigational ArmExperimentalThe investigation device for this study will be the ReNew Hip Implant.
Receives: Device: ReNew Hip Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6, 12, and 60 months

  2. The international Hip Outcome Tool-33 (iHOT-33)

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

    Measured: 6, 12, and 60 months

Secondary outcomes (7)

  1. Radiographic

    Imaging MRI of operative joint assessing the implant by MOCART 2.0 (modified), implant placement, joint effusion, and osteophytosis

    Measured: 6, 12, and 60 months

  2. Kaplan Meier survivorship

    Kaplan Meier survivorship of the ReNew Hip Implant in terms of revision and / or radiological migration

    Measured: 12, 24, and 60 months post-surgery

  3. Patient Reported Outcome Measures

    Difference demonstrated between pre-op and the post-op of all PROMs (mHHS, UCLA, PROMIS)

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

  4. Health economic outcomes

    Surgical blood loss; Measured in ml blood

    Measured: Time Frame: Intra-operative

  5. Health economic outcomes

    Length of hospital stay; Measure of days spent in hospital

    Measured: Time Frame: Hospital admission to discharge

  6. Health economic outcomes

    Operative time - first incision into skin to time when last suture is applied

    Measured: Intra-operative

  7. Health economic outcomes

    Re-hospitalizations for hip issues; Re-hospitalizations number of re-admissions to hospital

    Measured: Time Frame: Up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2025
  2. Study start6 Nov 2025
  3. Primary completionOct 2031 (estimated)
  4. Study completionOct 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, non-randomized, non-comparative, single-arm, open-label, multicenter, clinical study
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06823089
Sponsor's protocol ID
CIP-0001
Status last verified
Sep 2026
First submitted
22 Jan 2025
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: To be determined

Publications

  • 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.

    PubMed 21550411

  • 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.

    PubMed 22723242

Questions about this trial

What is this clinical trial studying?

A study testing ReNew Hip Implant in people with Osteoarthritis, Hip and Femoroacetabular Impingement, run by Cytex Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06823089, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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