Steroid Injection vs. BioDRestore for Patients With Knee OA

NCT ID: NCT02767492

Last Updated: 2021-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-01-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BioDRestore™

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

Group Type: EXPERIMENTAL

BioD Restore

Intervention Type: DEVICE

Investigational product, BioD Restore, will be injected into the articular space of the knee.

Corticosteroid

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

Group Type: ACTIVE_COMPARATOR

Kenalog

Intervention Type: DRUG

Active comparator, Kenalog steroid, will be injected into the articular space of the knee.

Interventions

BioD Restore

Investigational product, BioD Restore, will be injected into the articular space of the knee.

Intervention Type: DEVICE

Kenalog

Active comparator, Kenalog steroid, will be injected into the articular space of the knee.

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Integra LifeSciences Corporation

INDUSTRY

Sponsor Role: collaborator

The Hawkins Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Siffri, MD

Role: PRINCIPAL_INVESTIGATOR

Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Locations

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, United States

Countries

United States

References

Pill SG, Ahearn B, Tokish JM, Cook C, Siffri PJ, Mercuri JJ, Burnikel B, Cassas KJ, Wyland DJ, Sawvell E, Wright N, Hutchinson J, Bynarowicz T, Adams KJ, Kissenberth MJ. Amniotic Tissue Injections Are an Effective Alternative to Corticosteroid Injections for Pain Relief and Function in Patients With Severe Knee Osteoarthritis: A Double-Blind, Randomized, Prospective Study. J Am Acad Orthop Surg Glob Res Rev. 2025 Jan 9;9(1):e23.00276. doi: 10.5435/JAAOSGlobal-D-23-00276. eCollection 2025 Jan 1.

Reference Type: DERIVED

PMID: 39813395 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00048698

Identifier Type: -

Identifier Source: org_study_id