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NCT Number: NCT04446676

Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.

Participants after first-stage of knee infection reimplantation will be assign to one of two groups: with stem vs. with sleeve. Investigators will check participants on clinical, laboratory and reinfection signs. The main hypothesis is that better mechanical stability of endoprosthesis with sleeves will support infection treatment.

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gruca Teaching Hospital, Centre of Postgraduate Medical Centre

Otwock, Masovian Voivodeship, 05-400, Poland

Location status: Recruiting

Location contact

Paweł Bartosz

CONTACT

[email protected]

+48 793629685

About this study

All participants will be treated because of periprosthetic joint infection of the knee, after primary arthroplasty. All participants will be treated with two-stage protocol. In first stage debridement and spacer implantation will be performed. After 6-week antibiotics, when will be absent clinical or laboratory signs of reinfection, second stage will be performed. All participants upon fulfillment all inclusion and exclusion criteria will sign informed consent. With computer software patients will be randomized to one of two groups: with stem vs. with sleeve. After operation all patients will get target antibiotics for 3 weeks. Pre-operation and after on periodic controls will checked the Knee Society Score, The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC), Visual Analogue Scale. After 2-year observation evaluation of reinfection rate will be performed in both groups.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • second-stage of knee reimplantation
  • primary knee replacement in primary knee osteoarthritis
  • fulfillment of International Consensus Meeting 2018 infection criteria

Exclusion criteria

  • intraoperative bone defects Anderson Orthopedic Research Institute score >II
  • autoimmune disease
  • diabetes
  • peripheral vascular disease
  • congenital or acquired immunodeficiencies
  • lack of pathogens after first-stage
  • multi-bacterial infection
  • multidirectional instability
  • lack of patient consent

Treatment and study plan

stabilization with stem

Device

In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.

stabilization with sleeve

Device

In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.

Primary outcomes

  1. Reinfection

    Time frame: 2 years

    Rate of reinfection in both groups

Secondary outcomes

  1. Loosening radiological signs

    Time frame: 2 years

    Radiological evaluation of implant loosening with Modern Knee Society Radiographic Evaluation System

Other outcomes

  1. Knee Society Score

    Time frame: 1 year

    Clinical evaluation of patients after knee revision

  2. The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)

    Time frame: 1 year

    Clinical evaluation of patients after knee revision

  3. Visual Analogue Score

    Time frame: 1 year

    Clinical evaluation of patients after knee revision

  4. Alignment

    Time frame: 6 weeks

    Radiological alignment of knee after operation in degrees

  5. C-reactive protein

    Time frame: 1 year

    After operation and at period controls (mg/l)

  6. Erythrocyte sedimentation rate

    Time frame: 1 year

    After operation and at period controls (mm/h)

Study contacts

Contact information is provided by the study sponsor or research team.

Paweł Bartosz

CONTACT

[email protected]

+48 793629685

Sponsors and collaborators

Lead sponsor

Prof A Gruca Teaching Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Jun 25, 2020
Registry last updated
Mar 15, 2022

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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