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"Domino" Therapy Treat the Infection Around the Prosthesis After the Limb Salvage Surgery of Bone Tumor

Can "Domino" Therapy Effectively Treat the Infection Around the Prosthesis After the Limb Salvage Surgery of Bone Tumor?-----A Study of Sequential Therapy

Tumor resection and prosthetic replacement have become the treatments of choice for malignant bone tumors. Infections are the main cause of failure of limb salvage surgeries. Therefore, treatment of infections around prostheses after limb salvage is important, but is also challenging. Our research team designed a "domino" sequential treatment plan to treat postoperative infections around tumor prostheses and evaluated its efficacy.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Malignant bone tumors are associated with high mortality and disability rates. Developments over the past 20 years have made tumor resection and prosthetic replacement the preferred surgical treatments. Prosthetic reconstruction maintains the continuity of limb bones and leads to better joint function, but is often associated with complications such as loosening, fracture, and infection of the prosthesis. Among these, infection is the most important cause of failed limb salvage surgery. Postoperative infection rates of 5-25% have been reported in the literature. Infection is also the main cause of secondary amputation. Therefore, it is important to address infections around the prosthesis after limb salvage.

Investigators retrospectively analyzed the use of prosthesis-preserving sequential therapy to treat patients with peripheral prosthesis infections after bone-tumor limb salvage. Investigators summarized and analyzed the treatment processes and performed laboratory, imaging, and functional evaluations after treatment. The purpose was to introduce a new type of domino sequential treatment plan for treating postoperative infections of tumor prosthesis, and evaluate the technical points of the plan, and prognosis over medium- and long-term follow-ups.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

14

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310000
        • Department of Orthopedics, The Second Affiliated Hospital of Zhejiang University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Deep postoperative infections after replacement of a tumor-type prosthesis according to the 2011 diagnostic criteria of the Musculoskeletal Infection Society (MSIS) ;
  • Treated with debridement and lavage with prosthesis preservation, local application of antibiotics, and no loosening during intraoperative exploration;
  • With complete data for the main indicators (routine blood test results, C-reactive protein [CRP] level, erythrocyte sedimentation rate [ESR], X-ray and CT scans of the surgical site, and the Musculoskeletal Tumor Society [MTST] score).

Exclusion Criteria:

  • Underwent debridement without prosthesis preservation;
  • With a loose prosthesis during intraoperative exploration;
  • With poor soft tissue coverage, such that complete free muscle flap coverage could not be achieved; patients with renal insufficiency/failure (serum creatinine ≥ 2.0 mg/dL); patients with uncontrolled diabetes mellitus (hemoglobin A1c level > 8%);
  • In poor general condition who could not tolerate surgery.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: All the patients
domino therapy treat the infection around the prosthesis after the limb salvage surgery of bone tumor
The investigators evaluated routine blood test results, C-reactive protein level, the erythrocyte sedimentation rate, and other indicators. X-rays and CT scans of the surgical site were obtained and the Musculoskeletal Tumor Society (MSTS) score was calculated. Treatment involved debridement and lavage of the prosthesis, and systemic and local antibiotics.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
success rate of patients undergoing domino therapy assessed by MSIS diagnostic criteria
Tidsramme: 4 years

Sequential treatment failure was defined as failure to treat infection within 2 years of follow-up, indicated by meeting the 2011 MSIS diagnostic criteria of infection around the prosthesis.

The following formula was used to calculate the success rate: success rate = (total number of patients-number of failed cases)/total number of patients.

4 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Zhaoming Ye, Second Affiliated Hospital, School of Medicine, Zhejiang University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2017

Primær færdiggørelse (Faktiske)

1. oktober 2021

Studieafslutning (Faktiske)

1. oktober 2021

Datoer for studieregistrering

Først indsendt

25. januar 2022

Først indsendt, der opfyldte QC-kriterier

15. februar 2022

Først opslået (Faktiske)

24. februar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. februar 2022

Sidst verificeret

1. januar 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2021-0151 (Anden identifikator: M D Anderson Cancer Center)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Infektion

Kliniske forsøg med domino therapy

3
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