Status:
COMPLETED
"Domino" Therapy Treat the Infection Around the Prosthesis After the Limb Salvage Surgery of Bone Tumor
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Infection
Eligibility:
All Genders
Phase:
NA
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 i...
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 treatment...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05255185
Start Date
August 1 2017
End Date
October 1 2021
Last Update
February 24 2022
Active Locations (1)
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1
Department of Orthopedics, The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000