None listed
Conditions
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
Interventions
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 req
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.
Sponsors
Life Healthcare
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed