InfectionNCT05255185
"Domino" Therapy Treat the Infection Around the Prosthesis After the Limb Salvage Surgery of Bone Tumor
A study testing domino therapy in people with Infection, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection
- What is being tested?
- domino therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Orthopedics, The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
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
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.
Read the 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.
- Conditions
- Infection
- Being tested
- domino therapy
- Keywords
- Bone tumor, Limb salvage surgery, infection, Therapy effect
- Medical subject headings
- Infections, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
domino therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| All the patients | Experimental | domino therapy treat the infection around the prosthesis after the limb salvage surgery of bone tumor Receives: Procedure: domino therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Aug 2017
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaoming Ye, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255185
- Sponsor's protocol ID
- 2021-0151
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2022
- Last updated
- 24 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05255185
- Acronym / sponsor ID
- 2021-0151
- Conditions
- Infection
- Keywords
- Bone tumor, Limb salvage surgery, infection, Therapy effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All the patients | Experimental | Procedure: domino therapydomino therapy treat the infection around the prosthesis after the limb salvage surgery of bone tumor |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| domino therapyThe 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. | Procedure or surgery | All the patients |
Primary outcome
success rate of patients undergoing domino therapy assessed by MSIS diagnostic criteria
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoming Ye study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing domino therapy in people with Infection, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of patients undergoing domino therapy assessed by MSIS diagnostic criteria (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.