Steroid Injection vs. BioDRestore for Patients With Knee OA

NCT02767492 | Completed Results

• 1 other identifier: Pro00048698
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  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.

  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.

  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.

  Surgery to 12 months post op

Study Arms (2)

BioDRestore™

EXPERIMENTAL

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

Device: BioD Restore

Corticosteroid

ACTIVE COMPARATOR

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

Drug: Kenalog

Interventions

BioD Restore DEVICE

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

BioDRestore™

Kenalog DRUG

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

Corticosteroid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hawkins Foundation: lead
• Integra LifeSciences Corporation: collaborator

Study Sites (1)

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, 29615, United States

Location

Related Publications (1)

• 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.

  PMID: 39813395 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Kyle Adams
• Organization: Hawkins Foundation

kyle.adams@hawkinsfoundation.com

864 454-7458

Study Officials

• Paul Siffri, MD

  Steadman Hawkins Clinic of the Carolinas - Greenville Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 10, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: November 23, 2021
• Results First Posted: November 23, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)