Evidence map›Paper›PMID 39813395›Full record

Trial reportJournal of the American Academy of Orthopaedic Surgeons. Global research & reviews2025

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.

Stephan G Pill, Briggs Ahearn, John M Tokish, Chad Cook, Paul J Siffri, Jeremy J Mercuri, Brian Burnikel, Kyle J Cassas, Douglas J Wyland, Emily Sawvell and 5 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Stephan G PillFrom the Steadman Hawkins Clinic of the Carolinas, Prisma Health-Upstate, Greenville, SC (Dr. Pill, Dr. Ahearn, Dr. Siffri, Dr. Burnikel, Dr. Cassas, Dr. Wyland, and Dr. Kissenberth); the Mayo Clinic Arizona, Scottsdale, AZ (Dr. Tokish); the Department of Orthopaedics, Duke University, Durham NC (Dr. Cook); the Laboratory of Orthopaedic Tissue Regeneration & Orthobiologics, Department of Bioengineering, Clemson University, Clemson, SC (Dr. Mercuri, Mr. Sawvell, and Mr. Wright); the Frank H. Stelling and C. Dayton Riddle Orthopaedic Education and Research Laboratory, Clemson University Biomedical Engineering Innovation Campus, Greenville, SC (Dr. Mercuri, Mr. Sawvell, and Mr. Wright); and the Hawkins Foundation, Greenville, SC (Dr. Hutchinson, Dr. Bynarowicz, and Dr. Adams).ORCID 0000-0002-1627-5733
Briggs Ahearn
John M Tokish
Chad Cook
Paul J Siffri
Jeremy J Mercuri
Brian Burnikel
Kyle J Cassas
Douglas J Wyland
Emily Sawvell
Noah Wright
Josh Hutchinson
Taylor Bynarowicz
Kyle J Adams
Michael J Kissenberth

Funding

Integra LifeSciences
6 · The paper itself

Abstract

introductionThe use of corticosteroid injections for short-term pain relief for knee osteoarthritis can have deleterious adverse effects. Amniotic tissue has shown promise in vitro; therefore, this study compared a morcellized injectable amniotic tissue allograft to corticosteroid injection.

methodsEighty-one patients with symptomatic severe knee osteoarthritis (Kellgren-Lawrence grade 3 to 4) were prospectively randomized to either a double-blinded single injection of BioDRestore (Integra LifeSciences; n = 39) or triamcinolone acetonide (n = 42). Knee Injury and Osteoarthritis Outcome Score (KOOS), Single Alpha Numeric Evaluation, visual analog scale (VAS) pain, Lysholm Rating, and Veterans-Rand-12 scales at baseline, 6 weeks, 3, 6, and 12 months were analyzed.

resultsNo differences were observed in adverse reactions or patient reported outcomes (PROs); however, a notable continued improvement was found in the amnion group from 6 weeks to 1 year for Single Alpha Numeric Evaluation, Lysholm, and KOOS Symptoms, Pain, activities of daily living [ADL], QofL. The minimal clinically important difference (MCID) was met for Lysholm, KOOS ADL, and KOOS pain. DISCUSSION: Both amnion and steroid injections showed an initial improvement in pain relief and function at 6 weeks; however, more patients in the amniotic tissue group maintained pain relief and function at the 1-year follow-up. The mixed results suggest that amniotic tissue injections may be a safe and effective alternative to corticosteroid injections.

Indexed as

Adrenal Cortex HormonesAmnionGlucocorticoidsOsteoarthritis, KneePain ManagementTriamcinolone AcetonideAgedDouble-Blind MethodFemaleHumansInjections, Intra-ArticularMaleMiddle AgedPain MeasurementProspective StudiesTreatment OutcomeAdrenal Cortex HormonesGlucocorticoidsTriamcinolone Acetonide

Identifiers

PMID39813395
PMCPMC11723680

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.