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

NCT05255185 | Completed

• 1 other identifier: 2021-0151
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Keywords

Bone tumor; Limb salvage surgery; infection; Therapy effect

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

All the patients

EXPERIMENTAL

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

Procedure: domino therapy

Interventions

domino therapy PROCEDURE

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.

All the patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Department of Orthopedics, The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Infections; Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Zhaoming Ye

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 24, 2022
• Study Start: August 1, 2017
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: February 24, 2022

Record last verified: 2022-01

Locations

CN (1)