Arthoplasty, Infected Hernioplasty Mesh, PJI
Conditions
Keywords
Athroplasty, PJI, spacer, CUMARS, two-stage
Brief summary
The goal of this prospective observational study is to evaluate whether the use of a Custom-Made Articulating Spacer (CUMARS) can achieve satisfactory functional outcomes and effective infection control in patients undergoing two-stage revision for infected hip joints. The main questions it aims to answer are: Does the use of CUMARS provide acceptable functional outcomes during the interim period and after definitive reimplantation? Does CUMARS result in effective infection eradication with acceptable perioperative parameters and complication rates? Participants will: Undergo first-stage removal of the infected hip prosthesis and implantation of a Custom-Made Articulating Spacer Receive targeted systemic antibiotic therapy based on culture results Be followed up clinically and radiologically to assess function, complications, and infection status Undergo second-stage definitive hip reimplantation after confirmation of infection eradication
Detailed description
Purpose: This prospective study aimed to evaluate the functional outcomes, perioperative parameters, complication rates, and infection eradication achieved with the use of Custom-Made Articulating Spacer (CUMARS) in two-stage revision of infected hip joints. Methods: This prospective single-arm study was conducted at a tertiary referral center and included 25 patients with chronic hip joint infections . All patients underwent two-stage revision with implantation of a CUMARS construct at the first stage. Functional outcomes were assessed using the Modified Harris Hip Score (mHHS) and Visual Analogue Scale (VAS) for pain. Perioperative parameters, complication rates, and infection eradication were also evaluated during the 2 stage procedure . Minimum follow-up after reimplantation was 24 months.
Interventions
PROCEDUREthe use of Custom-Made Articulating Spacer (CUMARS) in two-stage revision of infected hip joints.
Participants will: Undergo first-stage removal of the infected hip prosthesis and implantation of a Custom-Made Articulating Spacer Receive targeted systemic antibiotic therapy based on culture results Be followed up clinically and radiologically to assess function, complications, and infection status Undergo second-stage definitive hip reimplantation after confirmation of infection eradication
Sponsors
Ain Shams University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age from 20-80 years old * Patients with PJI after hip arthroplasty according to MSIS criteria 2018 OR ICM 2018. * PJI \> 4 weeks post operative * Patients with chronic septic hip arthritis (either native or on top of infected proximal femur implant)
Exclusion criteria
* Age less than 20 years * Early postoperative PJI * Acute Hematogenous PJI * Fungal infection * Acute septic hip * gouty arthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcomes of CUMARS during interstage period | both measured preoperative and 1 month -postoperative first stage for each patient | Functional outcomes were assessed using the Modified Harris Hip Score (mHHS) ( ranges from a minimum of 0 points (worst possible function/highest pain) to a maximum of 100 points (best possible function/no pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact on second stage | Perioperative parameters surgery time meaured during 1st stage and 2nd stage procedures | Perioperative parameters surgery time meaured in minutes |
| Efficiency in controlling infection. | infection eradication rate 12 month post 2nd stage | Infection eradication rate in percentage (The number of participants experiencing reinfection divided by the total number of participants in the study arm, multiplied by 100". |
| Complication rate during interstage period | Complication rates during interstage period | Complication rates in percentage ( The number of participants experiencing one or more surgical complications divided by the total number of participants in the study arm, multiplied by 100") |
Countries
Egypt
Outcome results
None listed