An interventional study of ReNew Hip Implant in Osteoarthritis, Hip, Femoroacetabular Impingement and Osteonecrosis, sponsored by Cytex Therapeutics, Inc.. Active, not recruiting at 1 site in United States. Open to participants aged 14 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Cytex Therapeutics, Inc. · Not applicable, Interventional, and Device feasibility
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.
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.
641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.
This study's planned enrollment of 15 is below the median of 90 across 457 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →This is the only study on the registry with Cytex Therapeutics, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Able to understand the purpose of the study, his/her role, and is available for follow-up for the duration of the study:
Exclusion Criteria:
Femoral head is:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The investigation device for this study will be the ReNew Hip Implant.
Device: ReNew Hip Implant
Surgical Intervention
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
Time frame: 6, 12, and 60 months
The international Hip Outcome Tool-33 (iHOT-33)
Difference demonstrated between pre-op and post-op iHOT-33
Time frame: 6, 12, and 60 months
Radiographic
Imaging MRI of operative joint assessing the implant by MOCART 2.0 (modified), implant placement, joint effusion, and osteophytosis
Time frame: 6, 12, and 60 months
Kaplan Meier survivorship
Kaplan Meier survivorship of the ReNew Hip Implant in terms of revision and / or radiological migration
Time frame: 12, 24, and 60 months post-surgery
Patient Reported Outcome Measures
Difference demonstrated between pre-op and the post-op of all PROMs (mHHS, UCLA, PROMIS)
Time frame: 6, 12, 24, and 60 months post-surgery
Health economic outcomes
Surgical blood loss; Measured in ml blood
Time frame: Time Frame: Intra-operative
Health economic outcomes
Length of hospital stay; Measure of days spent in hospital
Time frame: Time Frame: Hospital admission to discharge
Health economic outcomes
Operative time - first incision into skin to time when last suture is applied
Time frame: Intra-operative
Health economic outcomes
Re-hospitalizations for hip issues; Re-hospitalizations number of re-admissions to hospital
Time frame: Time Frame: Up to 60 months
Plan to share: Undecided — To be determined
Started Nov 2025 (actual). Primary completion is estimated for Oct 2031, 71 months after the start.
Of 200 non-industry interventional studies with no phase under Osteoarthritis, Hip, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 71 months is above that.
Counting every sponsor, half of 226 studies reached it within 29 months; a quarter within 14 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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