Evidence map›Paper›PMID 37612739›Full record

ArticleBMC musculoskeletal disorders2023

Complications and radiographic changes after implantation of interspinous process devices: average eight-year follow-up.

Kai-Yu Li, Hua-Lin Li, Lin-Jie Chen, Jian-Wei Xiang, Chen-Chao Li, Jun-Jie Weng, Nai-Feng Tian

Open access · goldAbstract read
In one paragraph

Article in BMC musculoskeletal disorders, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.8field-weighted citation impact, top 26% 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

8 citing papers in PubMed, 3 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

7 authors at 2 institutions in 1 country.

Kai-Yu LiZhejiang Spine Research Center, Department of Spine Surgery, The Second Affiliated Hospital and Yuying, Children's Hospital of Wenzhou Medical University, 109 Xueyuanxi Road, Wenzhou, 325000, Zhejiang, China.
Hua-Lin LiZhejiang Spine Research Center, Department of Spine Surgery, The Second Affiliated Hospital and Yuying, Children's Hospital of Wenzhou Medical University, 109 Xueyuanxi Road, Wenzhou, 325000, Zhejiang, China.
Lin-Jie ChenZhejiang Spine Research Center, Department of Spine Surgery, The Second Affiliated Hospital and Yuying, Children's Hospital of Wenzhou Medical University, 109 Xueyuanxi Road, Wenzhou, 325000, Zhejiang, China.
Jian-Wei XiangZhejiang Spine Research Center, Department of Spine Surgery, The Second Affiliated Hospital and Yuying, Children's Hospital of Wenzhou Medical University, 109 Xueyuanxi Road, Wenzhou, 325000, Zhejiang, China.
Chen-Chao LiZhejiang Spine Research Center, Department of Spine Surgery, The Second Affiliated Hospital and Yuying, Children's Hospital of Wenzhou Medical University, 109 Xueyuanxi Road, Wenzhou, 325000, Zhejiang, China.
Jun-Jie WengZhejiang Spine Research Center, Department of Spine Surgery, The Second Affiliated Hospital and Yuying, Children's Hospital of Wenzhou Medical University, 109 Xueyuanxi Road, Wenzhou, 325000, Zhejiang, China.
Nai-Feng TianZhejiang Spine Research Center, Department of Spine Surgery, The Second Affiliated Hospital and Yuying, Children's Hospital of Wenzhou Medical University, 109 Xueyuanxi Road, Wenzhou, 325000, Zhejiang, China. tiannaifeng@163.com.
Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University · CNWenzhou Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study aims to evaluate complications, clinical outcomes, and radiographic results following Coflex implantation.

methodsWe retrospectively studied 66 patients who had decompressive surgery combined with Coflex implantation to treat lumbar spinal stenosis. All imaging data were collected and examined for imaging changes. Clinical outcomes, included Oswestry Disability Index (ODI), back and leg visual analog scale (VAS) scores, were evaluated before surgery, six months after surgery and at the last follow-up. The number of complications occurring after five years of follow-up was counted. All reoperation cases were meticulously recorded.

results66 patients were followed up for 5-14 years. The VAS and ODI scores were significantly improved compared with baseline. Heterotopic Ossification (HO) was detectable in 59 (89.4%). 26 (39.4%) patients had osteolysis at the contact site of Coflex with the spinous process. Coflex loosening was detected in 39 (60%) patients. Spinous process anastomosis was found in 34 (51.5%) patients. There was a statistically significant difference in the VAS score of back pain between patients with and without spinous process anastomosis. Nine cases of lumbar spinal restenosis were observed, and prosthesis fracture was observed in one case.

conclusionOur study identified various imaging changes after Coflex implantation, and majority of them did not affect clinical outcomes. The majority of patients had HO, but osteolysis and Coflex loosening were relatively rare. The VAS score for back pain of these patients was higher if they have spinous process anastomosis. After five-year follow-up, we found lumbar spinal restenosis and prosthesis fracture cases.

Indexed as

Fractures, BoneOsteolysisFollow-Up StudiesHumansProsthesis ImplantationReoperationRetrospective StudiesCoflexHeterotopic ossificationLooseningOsteolysisSpinous process anastomosis

Identifiers

PMID37612739
PMCPMC10463994
OpenAlexW4386092761

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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.