"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.

Study Overview

• Status: Completed
• Conditions: Infection
• Intervention / Treatment: Procedure: domino therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All the patients; domino therapy treat the infection around the prosthesis after the limb salvage surgery of bone tumor	Procedure: domino therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Zhaoming Ye, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: infection; Limb salvage surgery; Bone tumor; Therapy effect
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Musculoskeletal Diseases; Bone Diseases; Infections; Communicable Diseases; Bone Neoplasms
• Other Study ID Numbers: 2021-0151 (Other Identifier: M D Anderson Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No