Assessment of Functional Outcomes of Custom-made Articulating Spacers in Two Stage Arthroplasty for Treatment of Infected Hip Joint
NCT07453329
Arthoplasty, Infected Hernioplasty Mesh
Cairo, Egypt
View Trial DetailsNCT Number: NCT06806449
The goal of this observational study is to evaluate the infection control and mid-term survival of silver-coated articulated megaprosthetic and knee arthrodesis implants in PJI patients with bone stock deficiency and treated with two-stage protocol.
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Notify Me18 year and older
All sexes
Observational
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy
The majority of studies investigating the outcomes of silver-coated megaprostheses have evaluated case histories of megaprostheses in oncologic patients, while there is little evidence in the Literature of the outcomes of silver-coated megaprostheses in the treatment of infections in non-oncologic patients.
Knowing the mid- to long-term results of this type of implant is of great importance to inform the patient regarding expectations after surgery.
Obtaining more results and data on the treatment of knee PJI with silver-coated megaprostheses could pave the way for the design of prospective randomized comparative trials aimed at establishing the gold standard of treatment.
It is a nonprofit, observational, cohort, retrospective and prospective, multicenter, national study. Patients will be treated according to clinical practice in accordance with the judgment of the clinician.
The biographical and clinical-radiographic data that will be collected are:
All data and clinical and radiographic material will be collected together and analyzed at IRCCS Azienda Ospedaliero Universitaria di Bologna. All radiographic measurements will be performed by 3 independent operators after evaluation of intra- and inter-observer reliability on 10 random patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: through study completion, an average of 1 year
absence of clinical radiological and/or laboratory signs of infection or infected.
Time frame: Within 8 weeks and 24 months
Number and type of non-infection-related complications of "first-stage" within 8 weeks and "second-stage" within 24 months
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Results of Silver-coated Resection Prostheses in the Two-stage Treatment of Periprosthetic Knee Infections with Bone Deficiency
Acronym: MEGAPJI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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