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

NCT07453329 | Completed DMC

• 1 other identifier: MD 304\2022
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Arthoplasty; Infected Hernioplasty Mesh; PJI

Keywords

Athroplasty; PJI; spacer; CUMARS; two-stage

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Impact on second stage

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

• Impact on second stage

  blood loss during 1st stage and 2nd stage procedures

• Efficiency in controlling infection.

  infection eradication rate 12 month post 2nd stage

• Complication rate during interstage period

  Complication rates during interstage period

Study Arms (1)

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

Procedure: the use of Custom-Made Articulating Spacer (CUMARS) in two-stage revision of infected hip joints.

Interventions

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

Participants with chronic periprothetic hip joint infection

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Age less than 20 years
• Early postoperative PJI
• Acute Hematogenous PJI
• Fungal infection
• Acute septic hip
• gouty arthritis

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams univeristy

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 32922756 RESULT

• 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.

  PMID: 24851790 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: March 6, 2026
• Study Start: October 31, 2022
• Primary Completion: September 30, 2024
• Study Completion: October 31, 2024
• Last Updated: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)