Evidence map›Paper›PMID 32678055›Full record

Trial reportStem cell research & therapy2020

10-year follow-up results of the prospective, double-blinded, randomized, controlled study on autologous bone marrow buffy coat grafting combined with core decompression in patients with avascular necrosis of the femoral head.

Mengyuan Li, Yuanchen Ma, Guangtao Fu, Ruiying Zhang, Qingtian Li, Zhantao Deng, Minghao Zheng, Qiujian Zheng

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Stem cell research & therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01613612 (Control Study of Implantation of Enriched Bone Marrow Cells for the Treatment of Avascular Necrosis of Femoral Head), which is not on this map. Cited by 24 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 8 pooled it
4.0field-weighted citation impact, top 5% 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.

NCT01613612 phase2 / phase3unknown statusnot on this map

Control Study of Implantation of Enriched Bone Marrow Cells for the Treatment of Avascular Necrosis of Femoral Head

TypeinterventionalSponsorGuangdong Provincial People's HospitalRan2009 to 2012Enrolled60ConditionsAvascular Necrosis of Femur HeadArmscore decompression, Enriched BMCs implantation combined with core decompression
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 8 syntheses or guidelines pooled it, 48 citations in OpenAlex.

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  17. Cellular therapies for bone repair: current insights.Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology · 2024
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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

8 authors at 4 institutions in 2 countries.

Mengyuan LiDivision of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.
Yuanchen MaDivision of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.
Guangtao FuDivision of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.
Ruiying ZhangDivision of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.
Qingtian LiDivision of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.
Zhantao DengDivision of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.
Minghao ZhengCentre for Orthopaedic Translational Research, School of Surgery, The University of Western Australia, M Block, QE2 Medical Centre, Monash Ave., Nedlands, WA, 6009, Australia. Minghao.zheng@uwa.edu.au.
Qiujian ZhengDivision of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China. zhengqiujian@gdph.org.cn.
South China University of Technology · CNGuangdong Academy of Medical Sciences · CNGuangdong Provincial People's Hospital · CNUniversity of Western Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAvascular necrosis of the femoral head (ANFH) is a severely disabling disease of the hip. Several clinical trials have shown promising outcomes on the use of mesenchymal stem cells for the treatment of ANFH, but long-term clinical assessments are lacking. Previously, we reported the 2-year follow-up results of a prospective, double-blinded, randomized, controlled study on autologous bone marrow buffy coat grafting combined with core decompression in patients with ANFH. Here, we report the 10-year follow-up results of this study.

methodsWe recruited 43 (53 hips) patients from 2009 to 2010. The hips were randomly allocated to code decompression (CD) with or without bone marrow buffy coat (BBC) grafting. Participants underwent follow-up at 24, 60, and 120 months postoperatively. The visual analogue scale (VAS), Lequesne algofunctional index, and Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis scores were recorded. Survival rate analysis and prognostic factor analysis were performed. The endpoint was defined as progression to Ficat stage IV or conversion to hip arthroplasty.

resultsA total of 31 patients (41 hips) were included in the final analysis. The CD + BBC group had better subjective assessment scores than the CD group. The average survival times were 102.3 months and 78.1 months in the CD + BBC group and CD group, respectively (log-rank test, P = 0.029). In the univariate Cox proportional hazards regression model, age [hazard ratio (HR) = 1.079, P = 0.047] and preoperative Ficat stage (HR = 3.283, P = 0.028) indicated a high risk for progression, while the use of BBC (HR = 0.332, P = 0.042) indicated a low risk. Preoperative Ficat stage III was isolated as an independent risk factor for clinical failure in the multivariate model (HR = 3.743, P = 0.018).

conclusionThe 10-year follow-up results of this prospective, double-blinded, randomized, controlled study showed that the use of autologous BBC in combination with core decompression was more effective than the use of core decompression alone.

trial registrationClinicalTrials.gov, NCT01613612 . Registered on 13 December 2011-retrospectively registered.

Indexed as

Femur Head NecrosisBone MarrowDecompression, SurgicalDouble-Blind MethodFollow-Up StudiesHumansProspective StudiesTreatment OutcomeAutologous bone graftAvascular necrosis of the femoral headBone marrow buffy coatCore decompression

Identifiers

PMID32678055
PMCPMC7364559
OpenAlexW3043761436

What OpenQuestion holds

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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.