Steroid Injection vs. BioDRestore for Patients With Knee OA

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
BioDRestore™	BioD Restore	BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.
Corticosteroid	Kenalog	Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.

Primary Outcome Measures

Name	Time	Method
Single Alpha Numeric Evaluation (SANE)	Surgery to 12 months post-op.	Percentage of normal for affected knee between 0 to 100, with 100 being a perfectly "normal" knee and 0 being a completely "abnormal" knee.
Lysholm Knee Score	Surgery to 12 months post-op.	Patient reported knee function scores on a scale of 0-100, with 100 being a excellent outcome indicating no symptoms.
Visual Analog Pain Score	Surgery through 12 months post-op/	Patient reported level of pain on a scale of 0-10, with 10 being extreme pain and 0 being no pain.
Veterans Rand 12 Item Health Survey	Sugery to 12 months post-op	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
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Surgery to 12 months post op	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.

Secondary Outcome Measures

Name	Time	Method

Locations (1): Steadman Hawkins Clinic of the Carolinas
🇺🇸
Greenville, South Carolina, United States
Steadman Hawkins Clinic of the Carolinas
🇺🇸Greenville, South Carolina, United States