Evidence map›Paper›PMID 34141595›Full record

ArticleAsia-Pacific journal of sports medicine, arthroscopy, rehabilitation and technology2021

Randomized comparative study of suspension femoral fixation device in graft position maintenance in anterior cruciate ligament reconstruction: EndoButton CL vs TightRope RT.

Yoshimasa Ono, Yusuke Sato, Hiroki Mukai, Takahiro Enomoto, Seiji Kimura, Ryosuke Nakagawa, Ryuichiro Akagi, Yosuke Inaba, Yohei Kawasaki, Seiji Ohtori and 1 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Asia-Pacific journal of sports medicine, arthroscopy, rehabilitation and technology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.9field-weighted citation impact, top 15% 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

7 citing papers in PubMed, 10 citations in OpenAlex.

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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

11 authors at 1 institution in 1 country.

Yoshimasa OnoDepartment of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Japan.
Yusuke SatoDepartment of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Japan.
Hiroki MukaiDepartment of Diagnostic Radiology and Radiation Oncology, Chiba University, Japan.
Takahiro EnomotoDepartment of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Japan.
Seiji KimuraDepartment of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Japan.
Ryosuke NakagawaDepartment of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Japan.
Ryuichiro AkagiDepartment of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Japan.
Yosuke InabaBiostatistics Section, Clinical Research Center, Chiba University, Japan.
Yohei KawasakiBiostatistics Section, Clinical Research Center, Chiba University, Japan.
Seiji OhtoriDepartment of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Japan.
Takahisa SashoDepartment of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Japan.
Chiba University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn double-bundle anterior cruciate ligament reconstruction (ACLR), fixed-loop and adjustable-loop cortical suspensory devices are commonly used to fix the soft graft on the femoral side. However, few studies have compared in vivo elongation of the two devices. The purpose of this study was to determine whether EndoButton CL (EB) and TightRope RT (TR), the suspensory fixation devices used in ACLR, maintained their length in vivo from the time of surgery through the postoperative period in a randomized controlled trial.

methodsThis study prospectively incorporated 30 patients undergoing initial ACLR at a single center. Participants were divided into two groups using a stratified randomization method with age and sex as assignment adjustment factors. EB or TR was used for fixation of the soft graft on the femoral side. The primary endpoint was to compare the elongation distance of the suspensory device. MRIs were taken within seven days after ACLR and 3,6,12 months postoperatively and measured by a radiologist in a blinded fashion. Secondary endpoints included the side-to-side difference in anterior translation, one leg hop test (HOP index), Lachman test, lateral pivot shift test, and Lysholm score one year postoperatively.

resultsTwenty-eight patients (EB, n = 13; TR, n = 15) were followed for one year. There was no significant difference between EB and TR groups in elongation from the immediate postoperative period to 3, 6, 12 months after surgery. However, the non-inferiority of TR to EB (non-inferiority margin: 1.5 mm) was not proved by the difference in measured elongation between the two groups (TR - EB, lower 95% CI. AM: 1.80 mm; PL: 1.86 mm) at 6 months. There was no significant difference in anterior translation, HOP index, Lachman test, lateral pivot shift test, or Lysholm score.

conclusionEB and TR had similar graft retaining ability in vivo for 12 months, but the non-inferiority of TR against EB was not verified statistically.

Indexed as

Adjustable loopAnterior cruciate ligament reconstructionCortical suspensory fixation deviceFixed loop

Identifiers

PMID34141595
PMCPMC8184406
OpenAlexW3168435091

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.