Evidence map›Paper›PMID 34496821›Full record

ArticleBMC musculoskeletal disorders2021

An open-label randomized multi-Centre study to evaluate anterior controllable Antedisplacement and fusion versus posterior Laminoplasty in patients with cervical ossification of the posterior longitudinal ligament: study design and analysis plan (STAR).

Yu Chen, Jingchuan Sun, Dan Han, Xiaoqiu Yuan, Yuan Wang, Yongfei Guo, Xihua Zhong, Jiangang Shi

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC musculoskeletal disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04968028 (An Open-label Randomized Multi-centre Study to Evaluate Anterior Controllable Antedisplacement and Fusion Versus Posterior Laminoplasty in Patients With Cervical Ossification of the Posterior Longitudinal Ligament), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 31% 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.

NCT04968028 naactive not recruitingnot on this map

An Open-label Randomized Multi-centre Study to Evaluate Anterior Controllable Antedisplacement and Fusion Versus Posterior Laminoplasty in Patients With Cervical Ossification of the Posterior Longitudinal Ligament

TypeinterventionalSponsorShanghai Changzheng HospitalRan2021 to 2027Enrolled167ConditionsOssification of Posterior Longitudinal Ligament, Cervical Spondylosis With MyelopathyArmsACAF, Laminoplasty
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
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 1 institution in 1 country.

Yu Chen *Department of Orthopedic Surgery, Spine Centre, Changzheng Hospital, Naval Medical University, No. 415 Fengyang Road, Shanghai, 200003, People's Republic of China.
Jingchuan Sun *Department of Orthopedic Surgery, Spine Centre, Changzheng Hospital, Naval Medical University, No. 415 Fengyang Road, Shanghai, 200003, People's Republic of China.
Dan HanDepartment of Orthopedic Surgery, Spine Centre, Changzheng Hospital, Naval Medical University, No. 415 Fengyang Road, Shanghai, 200003, People's Republic of China.
Xiaoqiu YuanDepartment of Orthopedic Surgery, Spine Centre, Changzheng Hospital, Naval Medical University, No. 415 Fengyang Road, Shanghai, 200003, People's Republic of China.
Yuan WangDepartment of Orthopedic Surgery, Spine Centre, Changzheng Hospital, Naval Medical University, No. 415 Fengyang Road, Shanghai, 200003, People's Republic of China.
Yongfei GuoDepartment of Orthopedic Surgery, Spine Centre, Changzheng Hospital, Naval Medical University, No. 415 Fengyang Road, Shanghai, 200003, People's Republic of China.
Xihua ZhongData Statistics Centre, Shanghai KNOWLANDS MedPharm Consulting Co., Ltd., No. 1839 Qixin Rd, Shanghai, 201101, People's Republic of China.
Jiangang ShiDepartment of Orthopedic Surgery, Spine Centre, Changzheng Hospital, Naval Medical University, No. 415 Fengyang Road, Shanghai, 200003, People's Republic of China. changzhengspine@smmu.edu.cn.
Shanghai Changzheng Hospital · CN

Funding

shanghai hospital development centre SHDC2020CR1024B
6 · The paper itself

Abstract

backgroundIn treating patients with cervical ossification of the posterior longitudinal ligament (COPLL), a novel surgery technique - anterior controllable antedisplacement and fusion (ACAF) suggested promising clinical benefits in recent exploratory studies.

methodsThis is a multicentre, randomized, open-label, parallel-group, active controlled trial that will compare the clinical benefits of ACAF versus conventional posterior laminoplasty (LAMP) in severe COPLL patients. A total of 164 patients will be enrolled and randomized in a 1:1 ratio to either ACAF or LAMP group. The primary efficacy measure is cervical- Japanese Orthopaedic Association (C-JOA) recovery rate at 12 months post operation, which is to be derived by Hirabayashi's method from JOA data (range, 0 [worst] to 17 [normal condition]). Other important secondary efficacy endpoints include visual analogue scale (VAS) pain score (range, 0 [no pain] to 10 [most severe]), 10-item neck disability index (NDI, a total range of 0 to 50 points, the highest index the worst) and 6-level Nurick disability grade (range, 0 [mild] to 5 [severe]). Safety endpoints including adverse events, perioperative complications, and adverse events of special interest will also be assessed in this study. Full analysis set for baseline and efficacy data analyses according to the intention-to-treat principle will be established as the primary analysis population. Analysis of covariance (ANCOVA) will be used to analyze the C-JOA recovery rate, with random stratification factors (if appropriate) and the treatment group as fixed factors, and the baseline level of C-JOA score as covariate. DISCUSSION: This study is designed to demonstrate the clinical benefits of ACAF as compared to conventional LAMP in COPLL patients. It will provide clinical evidence that the novel surgery technique - ACAF might be more favorable in treating patients with severe cervical ossification of the posterior longitudinal ligament. (Words: 290).

trial registrationClinicalTrials.gov number, NCT04968028 .

Indexed as

LaminoplastyOssification of Posterior Longitudinal LigamentSpinal FusionCervical VertebraeDecompression, SurgicalHumansLongitudinal LigamentsMulticenter Studies as TopicOsteogenesisRandomized Controlled Trials as TopicRetrospective StudiesTreatment OutcomeAnterior controllable antedisplacement and fusionCervical ossification of the posterior longitudinal ligamentClinical outcomePosterior laminoplastyRandomized controlled trial

Identifiers

PMID34496821
PMCPMC8425037
OpenAlexW3196909683

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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.