Steroid Injection vs. BioDRestore for Patients With Knee OA

• Status: Completed
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hawkins Foundation
• Collaborators: BioD, LLC; Integra LifeSciences Corporation
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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).