Evidence map›Paper›PMID 30793358›Full record

ArticleJournal of orthopaedic research : official publication of the Orthopaedic Research Society2019

In vitro injection of osteoporotic cadaveric femurs with a triphasic calcium-based implant confers immediate biomechanical integrity.

John D Stroncek, Jonathan L Shaul, Dominique Favell, Ronald S Hill, Bryan M Huber, James G Howe, Mary L Bouxsein

Erratum issued Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Journal of orthopaedic research : official publication of the Orthopaedic Research Society, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04511364 (Long-term Follow-up in Osteoporotic Women Treated with Local Osteo-Enhancement in Europe), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.9field-weighted citation impact, top 10% of its field
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.

NCT04511364 naactive not recruitingnot on this mapstarted 2020, after this paper: background citation

Long-term Follow-up in Osteoporotic Women Treated with Local Osteo-Enhancement in Europe

TypeinterventionalSponsorAgNovos Healthcare, LLCRan2020 to 2025Enrolled60ConditionsOsteoporosisArmsClinical imaging is performed during the 24 and 60 month follow-up visits
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 23 citations in OpenAlex.

  1. Article
  2. How accurately do finite element models predict the fall impact response of ex vivo specimens augmented by prophylactic intramedullary nailing?Journal of orthopaedic research : official publication of the Orthopaedic Research Society · 2025
    Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Osteoporosis in 10 years time: a glimpse into the future of osteoporosis.Therapeutic advances in musculoskeletal disease · 2022
    Article
  8. Article
  9. Review
  10. Article
  11. Treatment of bone loss in proximal femurs of postmenopausal osteoporotic women with AGN1 local osteo-enhancement procedure (LOEP) increases hip bone mineral density and hip strength: a long-term prospective cohort study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2020
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

John D StroncekAgNovos Healthcare, 7301 Calhoun Place Suite 100, Rockville, Maryland 20855.
Jonathan L ShaulAgNovos Healthcare, 7301 Calhoun Place Suite 100, Rockville, Maryland 20855.
Dominique FavellAgNovos Healthcare, 7301 Calhoun Place Suite 100, Rockville, Maryland 20855.
Ronald S HillAgNovos Healthcare, 7301 Calhoun Place Suite 100, Rockville, Maryland 20855.
Bryan M HuberCopley Hospital, 528 Washington Hwy, Morrisville, Vermont 05661.
James G HoweAgNovos Healthcare, 7301 Calhoun Place Suite 100, Rockville, Maryland 20855.
Mary L BouxseinCenter for Advanced Orthopedic Studies, Beth Israel Deaconess Medical Center and Dept. of Orthopedic Surgery, Harvard Medical School, 330 Brookline Ave, Boston, Massachusetts 02215.
Agency for Healthcare Research and Quality · USHarvard University · USWashington Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Current pharmaceutical therapies can reduce hip fractures by up to 50%, but compliance to treatment is low and therapies take up to 18 months to reduce risk. Thus, alternative or complementary approaches to reduce the risk of hip fracture are needed. The AGN1 local osteo-enhancement procedure (LOEP) is one such alternative approach, as it is designed to locally replace bone lost due to osteoporosis and provide immediate biomechanical benefit. This in vitro study evaluated the initial biomechanical impact of this treatment on human cadaveric femurs. We obtained 45 pairs of cadaveric femurs from women aged 77.8 ± 8.8 years. One femur of each pair was treated, while the contralateral femur served as an untreated control. Treatment included debridement, irrigation/suction, and injection of a triphasic calcium-based implant (AGN1). Mechanical testing of the femora was performed in a sideways fall configuration 24 h after treatment. Of the 45 pairs, 4 had normal, 16 osteopenic, and 25 osteoporotic BMD T-scores. Altogether, treatment increased failure load on average by 20.5% (p < 0.0001). In the subset of osteoporotic femurs, treatment increased failure load by 26% and work to failure by 45% (p < 0.01 for both). Treatment did not significantly affect stiffness in any group. These findings provide evidence that local delivery of the triphasic calcium-based implant in the proximal femur is technically feasible and provides immediate biomechanical benefit. Our results provide strong rationale for additional studies investigating the utility of this approach for reducing the risk of hip fracture. © 2019 The Authors. Journal of Orthopaedic Research® Published by Wiley Periodicals, Inc. on behalf of Orthopaedic Research Society.

Indexed as

Calcium PhosphatesCalcium SulfateAgedAged, 80 and overBiomechanical PhenomenaFemaleFemurHip FracturesHumansMiddle AgedOsteoporosisProstheses and Implantscalcium phosphateCalcium PhosphatesCalcium Sulfatebone agingbone mechanics and finite element analysisbone tissue engineering and repair

Identifiers

PMID30793358
PMCPMC6593990
OpenAlexW2917174515

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.