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

Primary Purpose

Infection

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
domino therapy
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection focused on measuring Bone tumor, Limb salvage surgery, infection, Therapy effect

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Orthopedics, The Second Affiliated Hospital of Zhejiang University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All the patients

Arm Description

domino therapy treat the infection around the prosthesis after the limb salvage surgery of bone tumor

Outcomes

Primary Outcome Measures

success rate of patients undergoing domino therapy assessed by MSIS diagnostic criteria
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.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2022
Last Updated
February 15, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05255185
Brief Title
"Domino" Therapy Treat the Infection Around the Prosthesis After the Limb Salvage Surgery of Bone Tumor
Official Title
Can "Domino" Therapy Effectively Treat the Infection Around the Prosthesis After the Limb Salvage Surgery of Bone Tumor?-----A Study of Sequential Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
Bone tumor, Limb salvage surgery, infection, Therapy effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All the patients
Arm Type
Experimental
Arm Description
domino therapy treat the infection around the prosthesis after the limb salvage surgery of bone tumor
Intervention Type
Procedure
Intervention Name(s)
domino therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
success rate of patients undergoing domino therapy assessed by MSIS diagnostic criteria
Description
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.
Time Frame
4 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoming Ye
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Orthopedics, The Second Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

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

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