Assessment of Functional Outcomes of Custom-made Articulating Spacers in Two Stage Arthroplasty for Treatment of Infected Hip Joint

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

Study Overview

• Status: Completed
• Conditions: Arthoplasty; Infected Hernioplasty Mesh; PJI
• Intervention / Treatment: Procedure: the use of Custom-Made Articulating Spacer (CUMARS) in two-stage revision of infected hip joints.

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 12 months.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain shams univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Participants with chronic periprothetic hip joint infection; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2022
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: January 24, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: two-stage; spacer; PJI; Athroplasty; CUMARS
• Other Study ID Numbers: MD 304\2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No