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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 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with chronic periprothetic hip joint infection | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the use of Custom-Made Articulating Spacer (CUMARS) in two-stage revision of infected hip joints. | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | both measured preoperative and 1 month -postoperative first stage for each patient |
| Measure | Description | Time Frame |
|---|---|---|
| Impact on second stage | Perioperative parameters surgery time meaured in minutes | Perioperative parameters surgery time meaured during 1st stage and 2nd stage procedures |
| Impact on second stage |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams univeristy | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32922756 | Result | Zhang W, Fang X, Shi T, Cai Y, Huang Z, Zhang C, Lin J, Li W. Cemented prosthesis as spacer for two-stage revision of infected hip prostheses: a similar infection remission rate and a lower complication rate. Bone Joint Res. 2020 Aug 2;9(8):484-492. doi: 10.1302/2046-3758.98.BJR-2020-0173. eCollection 2020 Aug. | |
| 24851790 | Result |
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we will mention in our study
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Perioperative parameters :
blood loss in ML
| 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". | 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") | Complication rates during interstage period |
| Tsung JD, Rohrsheim JA, Whitehouse SL, Wilson MJ, Howell JR. Management of periprosthetic joint infection after total hip arthroplasty using a custom made articulating spacer (CUMARS); the Exeter experience. J Arthroplasty. 2014 Sep;29(9):1813-8. doi: 10.1016/j.arth.2014.04.013. Epub 2014 Apr 18. |