Evaluating The Use of Silver-coated Segmental Limb-Salvage Implants on the Risk of Surgical Site Infection: A Multi-centre Prospective Randomized Controlled Trial.

INTERVENTION: 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. CONDITION: Cancer ‐ Bone Cancer ‐ Other cancer types Cancer ‐ Sarcoma (also see 'Bone') ‐ soft tissue Infection ‐ Studies of infection and infectious agents Infection; ; Infection Injuries and Accidents ‐ Fractures Injuries and Accidents ‐ Other injuries and accidents Musculoskeletal ‐ Other muscular and skeletal disorders Surgery ‐ Other surgery Surgery ‐ Surgical techniques PRIMARY OUTCOME: 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. [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: Any change in the incidence of late‐stage infection in periprosthetic implants as determined by the Musculoskeletal Infection Society criteria. [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. ] 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. ; ; [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. ] Implant survival assessed by audit of patient medical records.[Postoperative review after 2 years ] 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.[Data collection at 2 years after final postoperative follow‐up. ] 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