Steroid Injection vs. BioDRestore for Patients With Knee OA

The Hawkins Foundation

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Device: BioD Restore; Drug: Kenalog

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02767492

Pro00048698

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

BioDRestore™

Experimental group

Description:

BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.

Treatment:

Device: BioD Restore

Corticosteroid

Active Comparator group

Description:

Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.

Treatment:

Drug: Kenalog