Steroid Injection vs. BioDRestore for Patients With Knee OA

Study Overview
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Brief Summary
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This study will include patients who are diagnosed with knee OA and are recommended for a knee injection. Study subjects will be randomized to receive either the standard of care knee injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be asked for permission for a baseline knee aspiration prior to the knee injection. At 6 months post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be followed for 1 year post-injection to include range of motion measurements and patient-reported pain/functional outcome measurements. X-rays will also be taken at the 1-year post-injection appointment.

Official Title
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A Double-blind, Randomized Study Comparing Steroid Injection and BioDRestore for Patients With Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: BioD Restore
* Drug: Kenalog


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18 to 80 years. Willing and able to give voluntary informed consent to participate in this investigation. Patient presents with knee osteoarthritis and Kellgren Lawrence grade 2-4 (OA diagnosed and confirmed by treating physician using standing x-ray). Candidate for intra-articular knee injection. BMI < 40 Exclusion Criteria: Patients who have received intra-articular injection(s) in the last 3 months. Patients who have undergone arthroscopic surgery on the study knee in the past year. Patients who have undergone arthroplasty on the study knee. Ligament instability Diabetes (Type 1 or II) Inflammatory arthropathies. Fibromyalgia or chronic fatigue syndrome. Female patient who is pregnant or nursing. Chronic use of narcotics. Any other reason (in the judgment of the investigator).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioDRestore™<br>BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint. | Device: BioD Restore<br>* Investigational product, BioD Restore, will be injected into the articular space of the knee.<br>|
| Active Comparator: Corticosteroid<br>Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint. | Drug: Kenalog<br>* Active comparator, Kenalog steroid, will be injected into the articular space of the knee.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Score | Patient reported level of pain on a scale of 0-10, with 10 being extreme pain and 0 being no pain. | Surgery through 12 months post-op/ | 
| Veterans Rand 12 Item Health Survey | Patient reported quality of life. Score contains a physical component and mental component score. Both scales are continuous and values range from 0 to 70, with higher scoring indicating higher physical and mental component scores | Sugery to 12 months post-op | 
| Lysholm Knee Score | Patient reported knee function scores on a scale of 0-100, with 100 being a excellent outcome indicating no symptoms. | Surgery to 12 months post-op. | 
| Single Alpha Numeric Evaluation (SANE) | Percentage of normal for affected knee between 0 to 100, with 100 being a perfectly normal knee and 0 being a completely abnormal knee. | Surgery to 12 months post-op. | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee outcome measure assessed via Knee Injury and Osteoarthritis Outcome Score (KOOS) on a scale of 0 to 100. The higher score of 100 indicates a fully functional knee without knee pain or problems. | Surgery to 12 months post op |