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NCT Number: NCT07453329

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

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Key information

Conditions

Arthoplasty Infected Hernioplasty Mesh PJI

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams univeristy

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Functional outcomes of CUMARS during interstage period

    Time frame: 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).

  2. Functional outcomes of CUMARS during interstage period

    Time frame: both measured preoperative and 1 month -postoperative first stage for each patient

    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).

Secondary outcomes

  1. Impact on second stage

    Time frame: Perioperative parameters surgery time meaured during 1st stage and 2nd stage procedures

    Perioperative parameters surgery time meaured in minutes

  2. Impact on second stage

    Time frame: blood loss during 1st stage and 2nd stage procedures

    Perioperative parameters :

    blood loss in ML

  3. Efficiency in controlling infection.

    Time frame: 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".

  4. Complication rate during interstage period

    Time frame: 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")

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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