Evidence map›Paper›PMID 33019480›Full record

ArticleMedicine2020

Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage Femur Head Necrosis: Protocol for a randomized controlled trial.

Qianchun Li, Rigao Chen, Yang Yu, Xinling Wang, Xueya Feng, Leiming Jiang, Botao Chen, Peng Xin, Tong Li, Yin Shi and 3 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 37% 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.

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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. 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

13 authors at 2 institutions in 1 country.

Qianchun LiSchool of Clinical Medicine, Chengdu University of Traditional Chinese Medicine.ORCID 0000-0003-0438-7786
Rigao ChenDepartment of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.
Yang YuDepartment of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.
Xinling WangDepartment of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.
Xueya FengDepartment of Anorectal Surgery, Nanchong Central Hospital, Nanchong.
Leiming JiangDepartment of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.
Botao ChenDepartment of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.
Peng XinDepartment of Intensive Care Unit, JianGe County Hospital of Traditional Chinese Medicine, Guangyuan, Sichuan, China.
Tong LiDepartment of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.
Yin ShiDepartment of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.
Qiang JianDepartment of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.
Zhongchao JiangDepartment of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.
Xiaohong FanDepartment of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.ORCID 0000-0002-7313-139
Chengdu University of Traditional Chinese Medicine · CNNanchong Central Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEarly diagnosis and treatment of the osteonecrosis of the femoral head (ONFH), a refractory disease, is imperative to prevent femoral head collapse; however, the existing solutions remain controversial. This study assessed the safety and efficacy of extracorporeal shock wave therapy (ESWT) combined with multiple drilling and intramedullary drug injection, a novel cocktail therapy, as a randomized controlled trial (RCT) model to postulate an alternative therapy for patients with early-stage ONFH.

methodsFemoral head necrosis patients aged 20 to 60 years with stage ARCO I-II were recruited. One hundred twenty eligible participants were randomized into four groups in a 1:1:1:1 ratio: extracorporeal shock wave therapy combined with multiple drilling and intramedullary drug injection (group EMI), extracorporeal shock wave therapy (group E), multiple drilling combined with intramedullary drug injection (group MI), and multiple drilling ("positive" control group; group M). The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema. Secondary outcomes included the Harris Hip Score and the visual analog scale. All outcomes were measured at the screening visit (baseline) and at the planned time intervals during treatment and follow-up, and the efficacy was statistically analyzed according to the intention-to-treat sub-populations and per-protocol sub-populations.

objectivesTo examine the clinical efficacy of ESWT combined with multiple drilling and intramedullary drug injection to provide a safe and more effective method for treating early-stage ONFH. TRIAL REGISTRATION NUMBER: ChiCTR1900020888; Pre-results.

Indexed as

Extracorporeal Shockwave TherapyFemur HeadFemur Head NecrosisInfusions, IntraosseousAdultArthroplasty, SubchondralBone Marrow DiseasesCombined Modality TherapyEarly DiagnosisEdemaFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective Studies

Identifiers

PMID33019480
PMCPMC7535671
OpenAlexW3091023262

What Socratic holds

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LicenceCC BY
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Registered trials

None linked

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 Socratic graph.