Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000769684
Ethics application status
Approved
Date submitted
23/06/2023
Date registered
14/07/2023
Date last updated
25/10/2023
Date data sharing statement initially provided
14/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating The Use of Silver-coated Segmental Limb-Salvage Implants on the Risk of Surgical Site Infection: A Multi-centre Prospective Randomized Controlled Trial.
Scientific title
Evaluating The Use of Silver-coated Segmental Limb-Salvage Implants on the Risk of Surgical Site Infection in Adults Undergoing Segmental Bone Reconstruction of the Distal Femur: A Multi-centre Prospective Randomized Controlled Trial.
Secondary ID [1] 309970 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection 330458 0
Condition category
Condition code
Surgery 327308 327308 0 0
Surgical techniques
Surgery 327309 327309 0 0
Other surgery
Infection 327379 327379 0 0
Studies of infection and infectious agents
Injuries and Accidents 327380 327380 0 0
Fractures
Injuries and Accidents 327381 327381 0 0
Other injuries and accidents
Musculoskeletal 327382 327382 0 0
Other muscular and skeletal disorders
Cancer 327383 327383 0 0
Bone
Cancer 327384 327384 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 327385 327385 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomisation comparing distal femur M-O-M TiN/silver Uncoated prosthesis (MUTARS) distal femur prosthesis. MUTARS segmental distal femoral implants with galvanised silver coating. Femoral implant surgery will be stratified between trauma, joint replacement and tumour surgical patient groups. Surgery will be conducted by qualified orthopaedic surgeons. Intervention will be delivered surgically once over a period of at least 2 hours, depending on the extent of patient anatomy and surgery time required. Infection will be assessed by clinically trained professionals (e.g. nurse and doctor) and presence or absence of infection will be recored at 2,5,14 & 30 days, 6 months, 1 year and 2 years. Patient reported outcomes will be collected 1, 6,12 and 24 months.
Intervention code [1] 326381 0
Treatment: Surgery
Intervention code [2] 326382 0
Treatment: Devices
Comparator / control treatment
Randomisation comparing MUTARS segmental distal femoral implants without galvanised silver coating. No differences between procedure types or surgical conduct.
Control group
Active

Outcomes
Primary outcome [1] 335170 0
The primary outcome of this study is to assess surgical site infection (SSI) prospectively by qualified medical or nursing staff, with the presence or absence of infection recorded at 2, 5, 14, 42 days, 6 months, 1 year and 2 years postoperatively.
Timepoint [1] 335170 0
2, 5, 14, & 42 (+/-2) days, 6 months, 1 year and 2 years postoperatively across all patient strata groups, or at any time a clinical indication of infection arises as determined by qualified medical staff.
Secondary outcome [1] 423385 0
Composite secondary outcomes will be assessed by determining any change in the incidence of secondary surgeries including wash out, soft tissue coverage, implant revision and amputation by audit of patient medical records postoperatively.

Timepoint [1] 423385 0
2, 5, 14, & 42 (+/-2) days, 6 months, 1 year and 2 years postoperatively across all patient strata groups, or at any time a clinical indication of infection arises as determined by qualified medical staff.
Secondary outcome [2] 423636 0
Any change in the incidence of late-stage infection in periprosthetic implants as determined by the Musculoskeletal Infection Society criteria.
Timepoint [2] 423636 0
2, 5, 14, & 42 (+/-2) days, 6 months, 1 year and 2 years postoperatively across all patient strata groups, or at any time a clinical indication of infection arises as determined by qualified medical staff.
Secondary outcome [3] 423637 0
Implant survival assessed by audit of patient medical records.
Timepoint [3] 423637 0
Postoperative review after 2 years
Secondary outcome [4] 423638 0
Perform a cost - benefit analysis by study-specific questionnaire for silver coating in limb salvage surgery by calculating the difference between resource use, hospital costs and out-of-pocket patient expenses.
Timepoint [4] 423638 0
Data collection at 2 years after final postoperative follow-up.

Eligibility
Key inclusion criteria
• Require segmental bone reconstruction of the distal femur following trauma, implant failure or resection of primary or secondary musculoskeletal malignancy
• Willing and able to provide informed consent for the trial
• Males and females 18 years or older
• Life expectancy > 12 weeks
• Medically fit for surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under 18 years of age
• Patients without the cognitive ability to understand the research
• Patients who refuse consent or elect to withdraw from the study
• Patients with untreatable metastatic disease or a life expectancy under 12 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation between tumour, failed joint replacement and trauma
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Poisson regression

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
28/06/2026
Actual
Sample size
Target
111
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 314145 0
Commercial sector/Industry
Name [1] 314145 0
Life Healthcare
Country [1] 314145 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Life Healthcare
Address
15 Talavera Road, North Ryde NSW 2113
Country
Australia
Secondary sponsor category [1] 316064 0
None
Name [1] 316064 0
Address [1] 316064 0
Country [1] 316064 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313280 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 313280 0
Hospital Avenue, Nedlands 6009, Western Australia
Ethics committee country [1] 313280 0
Australia
Date submitted for ethics approval [1] 313280 0
Approval date [1] 313280 0
04/05/2023
Ethics approval number [1] 313280 0

Summary
Brief summary
This trial is exploring the efficacy of coating limb implants with a galvanised silver layer for the prevention of surgical site infection.

Who is it for?
You may be eligible for this study if you are an adult who has undergone resection of primary or secondary musculoskeletal malignancy, and require subsequent segmental bone reconstruction of the distal femur. In addition, there will be other participant groups recruited including those requiring reconstruction following trauma or implant failure.

Study details
Participants will be randomly allocated to receive implants with or without a galvanised silver coating. The surgery will be performed by an orthopaedic surgeon. Participants will be asked to attend follow-up appointments for up to 2 years after the surgery to establish whether any surgical site infection or other complications have occurred.

It is hoped that information from this study will establish the utility of silver-coating limb salvage implants in reducing the risk of surgical site infection
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127586 0
Prof David Wood
Address 127586 0
University of Western Australia,
117 Stirling Highway
Nedlands
Perth Western Australia 6009
Country 127586 0
Australia
Phone 127586 0
+61 0417998574
Fax 127586 0
Email 127586 0
david.wood@uwa.edu.au
Contact person for public queries
Name 127587 0
Miss Caitlyn Aherne
Address 127587 0
Life Healthcare
Lobby 1, Level 1 153 Campbell St
Bowen Hills QLD 4006
Country 127587 0
Australia
Phone 127587 0
+61 0429582010
Fax 127587 0
Email 127587 0
caitlyn.aherne@lifehealthcare.com.au
Contact person for scientific queries
Name 127588 0
Prof David Wood
Address 127588 0
University Western Australia
117 Stirling Highway
Nedlands
Perth Western Australia 6009
Country 127588 0
Australia
Phone 127588 0
+61 0417998574
Fax 127588 0
Email 127588 0
david.wood@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19525Ethical approval    386132-(Uploaded-23-06-2023-19-24-55)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.