Evidence map›Paper›PMID 27179056›Full record

ArticleThe American journal of sports medicine2016

High Failure Rate of a Decellularized Osteochondral Allograft for the Treatment of Cartilage Lesions.

Jack Farr, Guilherme C Gracitelli, Nehal Shah, Eric Y Chang, Andreas H Gomoll

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in The American journal of sports medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05560477 (A Prospective, Randomized, Controlled, Double-Blinded, Multi-Center, Phase 1/2b Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing), which is not on this map. Cited by 33 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 2 pooled it
10.8field-weighted citation impact, top 1% 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.

NCT05560477 phase1 / phase2recruitingnot on this mapstarted 2023, after this paper: background citation

A Prospective, Randomized, Controlled, Double-Blinded, Multi-Center, Phase 1/2b Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing

TypeinterventionalSponsorUniversity of CincinnatiRan2023 to 2027Enrolled74ConditionsMeniscus TearArmsAM3101, Saline Placebo
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 2 syntheses or guidelines pooled it, 78 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 5 institutions in 2 countries.

Jack FarrCartilage Restoration Center of Indiana, OrthoIndy Hospital, Indianapolis, Indiana, USA jfarr@orthoindy.com.
Guilherme C GracitelliDepartment of Orthopaedic Surgery, Federal University of São Paulo, São Paulo, Brazil.
Nehal ShahBrigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Eric Y ChangRadiology Service, VA San Diego Healthcare System, San Diego, California, USA.
Andreas H GomollBrigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Brigham and Women's Hospital · USHarvard University · USIndiana Orthopaedic Hospital · USUniversidade Federal de São Paulo · BRVA San Diego Healthcare System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWidespread adoption of fresh allograft transplantation remains limited, predominantly by supply issues. To overcome these limitations, a preshaped, cylindrical sterilized and decellularized osteochondral allograft (SDOCA) implant was recently introduced as a clinical treatment option. PURPOSE: To evaluate functional outcomes and graft survivorship among patients treated with the SDOCA implant for knee cartilage injuries. STUDY

designCase series; Level of evidence, 4.

methodsAn institutional review board-approved database was used to identify a series of patients with prospectively collected data who had been treated with the SDOCA implant. The surgeries were performed at 2 centers by 2 surgeons. Patient-reported outcomes, magnetic resonance imaging (MRI), and the number and type of reoperations were assessed. Failure was defined as structural damage of the graft diagnosed by arthroscopy or MRI, and any reoperation resulting in removal of the allograft. Patients were evaluated pre- and postoperatively using the Knee injury and Osteoarthritis Outcome Score (KOOS) and Marx Sports Activity Scale. MRI was assessed preoperatively and postoperatively.

resultsThere were 32 patients with a mean age (±SD) of 35.1 ± 10.6 years; 59% were male. Twenty-three (72%) knees had previous surgery. The mean defect area (±SD) was 2.9 ± 2.0 cm(2), and the mean allograft size was 13.18 ± 2.3 mm (6 grafts ≤9 mm and 59 grafts ≥11 mm). The median number of allografts per knee was 2 (range, 1-5 grafts). Twenty-three of the 32 knees (72%) were considered failures by the definition detailed above. Of these, 14 knees (43%) had further surgery after the index procedure. Implant survivorship was 19.6% at 2 years. The mean follow-up duration was 1.29 years (range, 0.11-2.8 years). KOOS pain, activities of daily living (ADL), sports and recreation (sport/rec), and knee-related quality of life improved significantly from the preoperative visit to latest follow-up. Age was significantly predictive of failure, with a hazard ratio of 1.68 per 1 SD older (95% CI, 1.05-2.68; P = .030). The MOCART (magnetic resonance observation of cartilage repair tissue) feature effusion was the only score to correlate with KOOS (symptoms, pain, ADL, sport/rec).

conclusionThe SDOCA implant demonstrated a 72% failure rate within the first 2 years of implantation at these 2 institutions.

Indexed as

Activities of Daily LivingAdolescentAdultAgedAllograftsArthroscopyBone TransplantationCartilage, ArticularCartilage DiseasesChondrocytesFemaleFollow-Up StudiesGraft SurvivalHumansKnee InjuriesKnee Jointcartilageosteochondral allograftosteochondral defectosteochondral transplantation

Identifiers

PMID27179056
OpenAlexW2366120205

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.