Evidence map›Paper›PMID 35103855›Full record

Trial reportEuropean journal of orthopaedic surgery & traumatology : orthopedie traumatologie2023

An exploratory clinical trial for concentrated autologous bone marrow aspirate transplantation in the treatment of osteonecrosis of the femoral head.

Hisashi Sugaya, Tomokazu Yoshioka, Yohei Tomaru, Hiroshi Kumagai, Masashi Yamazaki, Hajime Mishima

Abstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in European journal of orthopaedic surgery & traumatology : orthopedie traumatologie, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 40% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Review
  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

6 authors at 1 institution in 1 country.

Hisashi SugayaDepartment of Health, Faculty of Health Sciences, Tsukuba University of Technology, Tsukuba, Japan. h.sugaya.1205@tsukuba-seikei.jp.ORCID http://orcid.org/0000-0003-3696-7726
Tomokazu YoshiokaDepartment of Orthopaedic Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Yohei TomaruDepartment of Orthopaedic Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Hiroshi KumagaiDepartment of Orthopaedic Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Masashi YamazakiDepartment of Orthopaedic Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Hajime MishimaDepartment of Orthopaedic Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
University of Tsukuba · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study evaluated the efficacy and safety of a novel treatment for osteonecrosis, in which concentrated autologous bone marrow aspirate transplantation (CABMAT) is followed by low-intensity pulsed ultrasound (LIPUS) stimulation for 3 months. The study was designed as a prospective, uncontrolled, open-label phase II clinical study.

methodsThis study included 16 cases of osteonecrosis of the femoral head (ONFH), including 26 hips. Patients were transplanted with concentrated bone marrow and periodically evaluated for infection and neoplasm development. Moreover, clinical and radiological examinations were conducted to confirm the treatment efficacy.

resultsNo infections were observed during the course of this study nor tumours developed at the treatment site 24 months after transplantation. At a mean 48 (30-56) months post-transplantation, the onset or progression of collapse was noted in four hips, of which one hip underwent total hip arthroplasty.

conclusionTreatment with CABMAT combined with 3-month LIPUS stimulation was safe, and further randomised clinical studies are needed to determine the efficacy and feasibility of this treatment.

trial registrationUMIN Clinical Trials Registry (UMIN000020940, 9/2/2016).

Indexed as

Bone MarrowFemur Head NecrosisBone Marrow TransplantationFemur HeadHumansProspective StudiesTransplantation, AutologousTreatment OutcomeBone marrow aspirate concentrateLow-intensity pulsed ultrasoundOsteonecrosis of the femoral headRegenerative medicine

Identifiers

PMID35103855
OpenAlexW4210611393

What OpenQuestion holds

Textmetadata
Read underepoch 390

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 OpenQuestion graph.