ArthoplastyNCT07453329
Assessment of Functional Outcomes of Custom-made Articulating Spacers in Two Stage Arthroplasty for Treatment of Infected Hip Joint
A study testing the use of Custom-Made Articulating Spacer (CUMARS) in two-stage revision of infected hip joints. in people with Arthoplasty and Infected Hernioplasty Mesh, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Arthoplasty, Infected Hernioplasty Mesh, PJI
- What is being tested?
- the use of Custom-Made Articulating Spacer (CUMARS) in two-stage revision of infected hip joints.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Oct 2022to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Age less than 20 years
- Early postoperative PJI
- Acute Hematogenous PJI
- Fungal infection
- Acute septic hip
- gouty arthritis
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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
Read the 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 24 months.
- Conditions
- Arthoplasty, Infected Hernioplasty Mesh, PJI
- Being tested
- the use of Custom-Made Articulating Spacer (CUMARS) in two-stage revision of infected hip joints.
- Keywords
- Athroplasty, PJI, spacer, CUMARS, two-stage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the use of Custom-Made Articulating Spacer (CUMARS) in two-stage revision of infected hip joints.Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: the use of Custom-Made Articulating Spacer (CUMARS) in two-stage revision of infected hip joints. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: both measured preoperative and 1 month -postoperative first stage for each patient
Secondary outcomes (4)
Impact on second stage
Perioperative parameters surgery time meaured in minutes
Measured: Perioperative parameters surgery time meaured during 1st stage and 2nd stage procedures
Impact on second stage
Perioperative parameters :
blood loss in ML
Measured: 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".
Measured: 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")
Measured: Complication rates during interstage period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start31 Oct 2022
- Primary completion30 Sep 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ArthoplastyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453329
- Sponsor's protocol ID
- MD 304\2022
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
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.
PubMed 32922756Tsung 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.
PubMed 24851790
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Functional Outcomes of Custom-made Articulating Spacers in Two Stage Arthroplasty for Treatment of Infected Hip Joint
- ClinicalTrials.gov ID
- NCT07453329
- Acronym / sponsor ID
- MD 304\2022
- Conditions
- Arthoplasty, Infected Hernioplasty Mesh, PJI
- Keywords
- Athroplasty, PJI, spacer, CUMARS, two-stage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with chronic periprothetic hip joint infection | Experimental | 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- Age less than 20 years
- Early postoperative PJI
- Acute Hematogenous PJI
- Fungal infection
- Acute septic hip
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Participants with chronic periprothetic hip joint infection |
Primary outcome
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).
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).
4 secondary outcomes
Impact on second stage
Time frame: Perioperative parameters surgery time meaured during 1st stage and 2nd stage procedures
Impact on second stage
Time frame: blood loss during 1st stage and 2nd stage procedures
Efficiency in controlling infection.
Time frame: infection eradication rate 12 month post 2nd stage
Complication rate during interstage period
Time frame: Complication rates during interstage period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Results publication: PubMed 32922756Zhang 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.
- Results publication: PubMed 24851790Tsung 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.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the use of Custom-Made Articulating Spacer (CUMARS) in two-stage revision of infected hip joints. in people with Arthoplasty and Infected Hernioplasty Mesh, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcomes of CUMARS during interstage period (time frame: both measured preoperative and 1 month -postoperative first stage for each patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07453329, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.