ReNu™ Injection to Treat Hip Osteoarthritis Study

Study Overview
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Brief Summary
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A pilot study to evaluate changes in hip function and pain in patients with osteoarthritis receiving the ReNu™ Hip Injection.

Detailed Description
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This is a prospective, non-randomized pilot study evaluating the efficacy of ReNu™ hip injection on patients with moderate osteoarthritis. The effects will be measured primarily through patient-reported outcomes questionnaires after a single injection. Patients will be followed up to 12 months to evaluate improvements using common pain and function subscales.

Official Title
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A Pilot Study of ReNu™ Hip Injection: Monitoring the Response of Hip Function and Pain in Patient With Osteoarthritis

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Other: ReNu™ Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with moderate hip osteoarthritis determined by a combination of clinical and radiographic findings Radiographic findings consistent with osteoarthritis as documented by Tonnis radiographic classification (Grade 1 or 2) Grade 1 Tonnis changes are defined as mild and include increased sclerosis, slight narrowing of the joint space, no or slight loss of head sphericity Grade 2 Tonnis changes are defined as moderate and include small cysts, moderate narrowing of the joint space, moderate loss of head sphericity Patients with bilateral grade 1or 2 Tonnis hip osteoarthritis who have bilateral symptoms may have their more symptomatic hip injected. If equivalent symptoms are reported by the patient, then the patient will choose which hip is to be injected. The other Hip can be treated with all standard local interventions that will not have a prolonged systemic effect that could affect the study hip (for example steroid injection, cold therapy, soft braces). Between the Ages 18 to 70 with minimum activity level of 2 on the Tegner scale. BMI less than 40 Female patients must be actively practicing a contraception method, abstinence, be surgically sterilized, or be postmenopausal Exclusion Criteria: Pain medication (including NSAIDs) less than 15 days before injection (may take acetaminophen) Receiving pain medication other than acetaminophen for conditions unrelated to osteoarthritis of the index hip Regular use of anticoagulants, such as Coumadin, dabigatran or rivaroxaban; use of antiplatelet medications are not a reason for exclusion History of substance abuse. Failure to agree NOT to take additional hip symptom modifying drugs, other than acetaminophen, during the course of the study without reporting to the study team Pregnancy or desire to become pregnant during study duration Corticosteroid injection into the index hip within 6 months Viscosupplement injection into the index hip within 6 months Previous open or arthroscopic hip surgery of the involved index hip within the previous 6 months Open or arthroscopic surgery of the contralateral hip within the last 6 months Worker compensation Acute index hip injury (injury within 3 months) History of Diabetes mellitus History of solid organ or hematologic transplantation History of rheumatoid arthritis or other autoimmune disorder Diagnosis of a non-basal cell malignancy within the preceding 5 years Infection requiring antibiotic treatment within the preceding 3 months Current therapy with any immunosuppressive medication, including corticosteroids at a dose > 5 mg per day

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReNu™ Injection<br>ReNu™ is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid. | Other: ReNu™ Injection<br>* Injection into the hip for the treatment of Osteoarthritis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IHOT12 - International Hip Outcome Tool 12 | Change from Baseline | 3 & 6 months | 
| Visual Analog Scale (VAS) Pain Scale | Change from Baseline | 3 & 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Harris Hip Score | Change from Baseline | 3, 6 & 12 months | 
| SF12 Score | Generic measure of patient's health status change from baseline | 3, 6 & 12 months | 
| Single Assessment Numerical Evaluation (SANE) | Measurement tool used to record patient's self-reported change in function from baseline | 3, 6 & 12 months |