Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2020
CompletedFirst Posted
Study publicly available on registry
June 25, 2020
CompletedStudy Start
First participant enrolled
November 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
March 15, 2022
March 1, 2022
5.6 years
June 21, 2020
March 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reinfection
Rate of reinfection in both groups
2 years
Secondary Outcomes (1)
Loosening radiological signs
2 years
Other Outcomes (6)
Knee Society Score
1 year
The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
1 year
Visual Analogue Score
1 year
- +3 more other outcomes
Study Arms (2)
Stem stabilization
ACTIVE COMPARATORGroup of patients with stem endoprosthesis stabilization
Sleeve stabilization
ACTIVE COMPARATORGroup of patients with sleeve endoprosthesis stabilization
Interventions
In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
Eligibility Criteria
You may qualify if:
- second-stage of knee reimplantation
- primary knee replacement in primary knee osteoarthritis
- fulfillment of International Consensus Meeting 2018 infection criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gruca Teaching Hospital, Centre of Postgraduate Medical Centre
Otwock, Masovian Voivodeship, 05-400, Poland
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paweł Bartosz
Prof. A. Gruca Teaching Hospital in Otwock
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Ph.D.
Study Record Dates
First Submitted
June 21, 2020
First Posted
June 25, 2020
Study Start
November 17, 2020
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
March 15, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- 1 year
Study protocol and Informed consent form will be shared