Steroid Injection vs. BioDRestore for Patients With Knee OA

NCT02767492 — Not applicable, Completed, 90 participants, The Hawkins Foundation

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A Double-blind, Randomized Study Comparing Steroid Injection and BioDRestore for Patients With Knee Osteoarthritis

Registry	NCT02767492
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	90 (Actual)
Sponsor	The Hawkins Foundation (Other); collaborators: Integra LifeSciences Corporation
Conditions	Knee Osteoarthritis
Interventions	BioD Restore, Kenalog (Device, drug)
Dates	start 2017-01-01, primary completion 2020-01-01, completion 2020-01-01, first posted 2016-05-10, last updated 2021-11-23
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
BioDRestore™	Experimental	Device: 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	Active comparator	Drug: Kenalog	Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.

BioD Restore (Device): Investigational product, BioD Restore, will be injected into the articular space of the knee.
Kenalog (Drug): Active comparator, Kenalog steroid, will be injected into the articular space of the knee.

+Outcome measures

Primary outcomes

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
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.
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.
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.

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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).

+Posted results

Participant flow

Milestone	BioDRestore™	Corticosteroid
Started	45	45
Completed	35	35
Not completed	10	10

Outcome results

Visual Analog Pain Score (Primary), Mean, score on a scale: BioDRestore™ 2.49 +/- 2.41; Corticosteroid 3.25 +/- 2.82
Veterans Rand 12 Item Health Survey (Primary), Mean, score on a scale: BioDRestore™ 56.95 +/- 9.84; Corticosteroid 58.01 +/- 7.49
Lysholm Knee Score (Primary), Mean, score on a scale: BioDRestore™ 75.26 +/- 17.75; Corticosteroid 61.00 +/- 22.00
Single Alpha Numeric Evaluation (SANE) (Primary), Mean, score on a scale: BioDRestore™ 66.14 +/- 23.27; Corticosteroid 60.49 +/- 25.37
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Primary), Mean, score on a scale: BioDRestore™ 64.10 +/- 21.23; Corticosteroid 55.67 +/- 22.23

Adverse events

Time frame: 12 months

Arm	Deaths	Serious adverse events	Other adverse events
BioDRestore™	0/45 (0.0%)	0/45 (0.0%)	0/45 (0.0%)
Corticosteroid	0/45 (0.0%)	0/45 (0.0%)	0/45 (0.0%)

+Locations (1)

Facility	City	Country	Status
Steadman Hawkins Clinic of the Carolinas	Greenville, South Carolina	United States

+Publications

Results publication: 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

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2017-01-05)

+Investigators

Paul Siffri, MD, Principal investigator, Steadman Hawkins Clinic of the Carolinas - Greenville Health System