An interventional study of the use of Custom-Made Articulating Spacer (CUMARS) in two-stage revision of infected hip joints. in Arthoplasty, Infected Hernioplasty Mesh and PJI, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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
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.
Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Procedure: the 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
Functional outcomes of CUMARS during interstage period
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).
Time frame: both measured preoperative and 1 month -postoperative first stage for each patient
Functional outcomes of CUMARS during interstage period
Visual Analogue Scale (VAS) typically consists of a 10-cm horizontal anchored by "no pain" (0) and "worst imaginable pain" (10) . The minimum score is 0 (no pain), and the maximum score is 10 (worst pain).
Time frame: both measured preoperative and 1 month -postoperative first stage for each patient
Impact on second stage
Perioperative parameters surgery time meaured in minutes
Time frame: Perioperative parameters surgery time meaured during 1st stage and 2nd stage procedures
Impact on second stage
Perioperative parameters : blood loss in ML
Time frame: blood loss during 1st stage and 2nd stage procedures
Efficiency in controlling infection.
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".
Time frame: infection eradication rate 12 month post 2nd stage
Complication rate 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")
Time frame: Complication rates during interstage period
Plan to share: No — we will mention in our study * the age and gender * all the comorbidities of participants * causes of arthroplasty * causes of infection * the caustive organisms of infection * the complications all will be available in the study * we can not reveal the participant names
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Ain Shams University