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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorProf A Gruca Teaching Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

second-stage of knee reimplantation

primary knee replacement in primary knee osteoarthritis

fulfillment of International Consensus Meeting 2018 infection criteria

Disqualifiers

intraoperative bone defects Anderson Orthopedic Research Institute score >II

autoimmune disease

diabetes

peripheral vascular disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Stem stabilizationActive comparator 1 intervention
Group B: Sleeve stabilizationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Reinfection

Rate of reinfection in both groups

Time frame
2 years

Secondary outcomes

1

Loosening radiological signs

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

Time frame
2 years

Other outcomes

1

Knee Society Score

Clinical evaluation of patients after knee revision

Time frame
1 year
2

The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)

Clinical evaluation of patients after knee revision

Time frame
1 year
3

Visual Analogue Score

Clinical evaluation of patients after knee revision

Time frame
1 year
4

Alignment

Radiological alignment of knee after operation in degrees

Time frame
6 weeks

Sponsors and contacts

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