Clinical trial of an antibiotic-loaded mold spacer for the control of infection caused by hip replacement

Clinical trial of an antibiotic-loaded mold spacer for the control of infection caused by hip replacement: a pilot clinical trial study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191111045400N5

Enrollment

Registered

2024-10-25

Start date

2024-10-21

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthetic Joint Infection. Infection and inflammatory reaction due to internal joint prosthesis

Interventions

Intervention 1: Intervention group: The group that has SILICONE-based spacers that were produced with a mold, In order to use this device in surgery, after sterilization, antibiotic cement is poured

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: presence of a draining sinus MRI evidence of a septic arthritis with osteomyelitis

Exclusion criteria

Exclusion criteria: polyarticular joint involvement

Design outcomes

Primary

Measure	Time frame
Physical function. Timepoint: 1 month, 3 months, 6 months and one year after surgery. Method of measurement: They are scored through the WOMAC Score questionnaire .	—

Secondary

Measure	Time frame
Physical function. Timepoint: 1 month, 3 months, 6 months and one year after surgery. Method of measurement: They are scored through the WOMAC Score questionnaire .	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mohamad Amin Younessi Heravi

Bojnourd University of Medical Sciences

a.younessi7@gmail.com+98 58 3151 1423

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026