Steroid Injection vs. BioDRestore for Patients With Knee OA

The Hawkins Foundation90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Surgery to 12 months post op