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Clinical trial of a new silicone mold for dynamic spacer production during knee surgery: a pilot clinical trial study

Clinical trial of a new silicone mold for dynamic spacer production during knee surgery: a pilot clinical trial study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191111045400N2
Enrollment
7
Registered
2023-07-12
Start date
2023-07-23
Completion date
Unknown
Last updated
2023-07-25

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 spacers that were produced with a mold, In order to use this device in surgery, after sterilization, antibiotic cement is poured into it and afte

Sponsors

Bojnourd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: aspiration of infectious synovial fluid from patient (determined by differential count of the number of white blood cells and the percentage of polymorphonuclear leukocytes) isolation of organism(s) from synovial Fluid of patient presence of a draining sinus MRI evidence of a septic arthritis with osteomyelitis

Exclusion criteria

Exclusion criteria: polyarticular joint involvement

Design outcomes

Primary

MeasureTime 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 and the Oxford Knee Score questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohamad Aamin Younessi

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