An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis

Study Overview
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Brief Summary
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This is a Prospective, Randomized study evaluating the efficacy of ReNu for the treatment of Kellgren-Lawrence grade 2 or 3 osteoarthritis. Patients will be randomized into 1 of 3 groups for injection into the effected knee: 1) ReNu - study treatment, 2) Hyaluronic Acid (HA) injection - with commonly used injection material and 3) Saline. After treatment, patients will be followed up to 12 months to evaluate improvements using common pain and function subscales.

Official Title
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An Investigation of ReNu™ Knee Injection: Monitoring the Response of Knee Function and Pain in Patients With Osteoarthritis

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: Knee injection
* Other: ReNu amniotic allograft
* Device: placebo saline
* Device: Hyaluronic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with moderate knee osteoarthritis determined by a combination of clinical and radiographic findings and documented by Kellgren-Lawrence radiographic classification (Grade 2 or 3) Grade 2 Kellgren-Lawrence radiographic changes are defined as small osteophytes, possible narrowing of joint space Grade 3 Kellgren-Lawrence radiographic changes are defined as moderate multiple osteophytes, definite narrowing of joints space, some sclerosis and possible deformity of bone contour. Patients with bilateral grade 2 or 3 Kellgren Lawrence knee osteoarthritis who have bilateral symptoms may have their more symptomatic knee injected. If equivalent symptoms are reported by the patient, then the patient will choose which knee is to be injected. The contralateral knee can be treated with local standard of care such as steroid injection, cold therapy or soft brace. Age 18 and older BMI less than 40 7 day average pain score of 4 or greater for the involved knee on a numeric pain scale from 1 to 10. Female patients must be actively practicing a contraception method, abstinence, be surgically sterilized, or be postmenopausal Exclusion Criteria: Pain medication (including nonsteroidal antiinflammatory drugs, NSAIDs) less than 15 days before injection (may take acetaminophen) Receiving pain medication other than acetaminophen for conditions unrelated to osteoarthritis of the index knee 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 knee 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 Positive pregnancy test on premenopausal subject Morbid obesity (defined as BMI 40 or greater) Symptoms of locking, intermittent block to range of motion or loose body sensation which could indicate meniscal displacement or an intraarticular loose body Corticosteroid injection into the index knee within 3 months Viscosupplement injection into the index knee within 3 months Knee surgery of involved index knee within 12 months Knee surgery contralateral knee 6 months Worker compensation Acute index knee 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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReNu amniotic allograft<br>Knee injection with ReNu. ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid. | Procedure: Knee injection<br>* Injection into knee for the treatment of Osteoarthritis<br>Other: ReNu amniotic allograft<br> <br> |
| Placebo Comparator: Saline<br>Knee injection with saline. Injectable saline will be used as the placebo control. | Procedure: Knee injection<br>* Injection into knee for the treatment of Osteoarthritis<br>Device: placebo saline<br> <br> |
| Active Comparator: HA injection<br>Knee injection with HA. HA will be used as a viscosupplementation injection consisting of cross linked HA. | Procedure: Knee injection<br>* Injection into knee for the treatment of Osteoarthritis<br>Device: Hyaluronic Acid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Pain Scale Change from Baseline |  | 3 months | 
| VAS Pain Scale Change from Baseline |  | 6 months | 
| KOOS Pain and Function Subscales Change from Baseline |  | 3 months | 
| KOOS Pain and Function Subscales Change from Baseline |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS Pain and Function Subscales change from Baseline |  | 1 week, 6 weeks, 3 months, and 12 months | 
| Other patient reported outcomes (PROs) change from Baseline |  | 1 week, 6 week, 3 months, 6 months, and 12 months | 
| Radiographic (X-ray) measurement of standing joint space change from Baseline |  | 12 months |