Evidence map›Paper›PMID 40080289›Full record

Trial reportJournal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology2025

Female patients report comparable results to males after the implantation of an aragonite-based scaffold for the treatment of knee chondral and osteochondral defects: a gender-based analysis of a RCT at 4 years' follow-up.

Elizaveta Kon, Francesca De Caro, Vinod Dasa, Jason M Scopp, Berardo Di Matteo, David Flanigan, Nogah Shabshin, Sabrina Strickland, Nir Altschuler

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03299959 (A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C™ vs. Surgical Standard of Care), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT03299959 nacompletednot on this map

A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C™ vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee

TypeinterventionalSponsorSmith & Nephew, Inc.Ran2017 to 2024Enrolled251ConditionsCartilage or Osteochondral Defects in the Knee, Up to Moderate OsteoarthritisArmsAgili-C implant, SSOC
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
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

9 authors.

Elizaveta KonDepartment of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Pieve Emanuele, 20090, Milan, Italy.
Francesca De CaroDepartment of Orthopaedics, Istituto di Cura Città di Pavia, Pavia, Italy.
Vinod DasaDepartment of Orthopaedic Surgery, Louisiana State University Health Sciences Center, New Orleans, LA, USA.
Jason M ScoppJoint Preservation Center, Peninsula Orthopaedic Associates, P.A., Salisbury, MD, USA.
Berardo Di MatteoDepartment of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Pieve Emanuele, 20090, Milan, Italy. berardo.dimatteo@gmail.com.
David FlaniganThe Ohio State University Wexner Medical Center, Columbus, OH, USA.
Nogah ShabshinDivision of Musculoskeletal Imaging, Department of Radiology, Penn Musculoskeletal Center, Philadelphia, PA, USA.
Sabrina StricklandSports Medicine and Shoulder Service, Hospital for Special Surgery, Cornell University Medical College, New York, NY, USA.
Nir AltschulerCartiheal Ltd, Tel Aviv, Israel.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of the study was to provide a gender-based analysis of the results of a large, multi-centre randomized controlled trial (RCT) comparing a novel cell-free aragonite-based scaffold with the standard of care (i.e. debridement/microfractures) for the treatment of chondral/osteochondral defects in knees with or without concurrent osteoarthritis. MATERIALS AND

methodsA total of 251 patients were included: 167 patients in the scaffold group and 84 in the control. In the scaffold group, there were 105 males and 59 females, whereas the control group consisted of 51 males and 32 females. Patients were evaluated up to 48 months after the treatment. The primary endpoint was the change from baseline to 48 months in the KOOS overall score. Treatment failures were defined as any secondary invasive intervention, including intra-articular injection or any surgery in the treated joint. All patients underwent magnetic resonance imaging (MRI) at 12 and 24 months to assess the percentage of defect fill after surgery.

resultsBoth males and females in the scaffold group achieved significantly better results than controls in any KOOS subscale, as well as in KOOS overall, up to the final 48 months follow-up. Outcomes reported by females were non-inferior to those of males in the implant group. At 24 months' MRI evaluation, 86.2% of male patients in the scaffold group presented at least 75% defect fill compared with 32.6% in the control group. In the scaffold group, 87.6% of female patients presented at least 75% defect fill, compared with 28% in the control group (p < 0.0001 in both cases). Responders' rate and failure rate were also significantly better in the scaffold group for both males and females.

conclusionThe aragonite scaffold outperformed the control group at 48 months' evaluation. The gender-based analysis proved that males and females in the scaffold group presented comparable clinical and radiographical results, both significantly better than their counterparts treated by debridement/microfractures. LEVEL OF EVIDENCE: I-Randomized controlled trial.

trial registrationClinicaltrial.gov ID: NCT03299959 (registered on 14 September 2017).

Indexed as

Calcium CarbonateCartilage, ArticularKnee JointOsteoarthritis, KneeTissue ScaffoldsAdultFemaleFollow-Up StudiesHumansMagnetic Resonance ImagingMaleMiddle AgedSex FactorsTreatment OutcomeCalcium CarbonateAragoniteCartilageGenderMicrofractureRandomizedScaffold

Identifiers

PMID40080289
PMCPMC11906925

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.