Back to resultsInfection Rate of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study
Primary Purpose
Infection Joint, Joint Infection, Arthroplasty Complications
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Simultaneous bilateral total knee arthroplasty
Sequenced bilateral TKA
Sponsored by
About this trial
This is an interventional treatment trial for Infection Joint
Eligibility Criteria
Inclusion Criteria:
Primary bilateral knee osteoarthritis with refractory to conservative treatment Patients who accept participation in the research and the randomization
Exclusion Criteria:
no history of malignancy without severe extra-articular deformities
Sites / Locations
- Bezmialem Vakif UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Two surgeon bilateral TKA group
Single surgeon bilateral TKA group
Arm Description
2 surgeons will perform simultaneous total knee arthroplasty in this group.
One surgeon will perform sequentially tptal knee arthroplasty in this group
Outcomes
Primary Outcome Measures
Infection incedence
Early infection rates
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04413565
Brief Title
Infection Rate of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study
Official Title
Infection Rate of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 8, 2016 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The use of bilateral total knee replacements (TKR) is increasing with the number of patients with bilateral end-stage knee osteoarthritis. Bilateral TKR can be performed in three different ways: single-stage, two-team simultaneous bilateral TKR (two surgeons bilateral TKR); single-stage, a sequential bilateral TKR (single surgeon bilateral TKR); and two-stage bilateral TKR. Periprosthetic joint (PJI) infections are serious complications after TKR that negatively affect the aimed outcome, decrease patient satisfaction, and increase morbidity and mortality. The incidence of PJI is 1-2% and the number of cases is projected to grow as the indications for TKR continue to increase. Investigators will prospectively compare the incidence of periprosthetic joint infection between groups.
Detailed Description
924 knees (462 participants) will prospectively be randomized into 2 groups: two surgeons bilateral TKA and single surgeon bilateral TKA. While 2 surgeons will perform simultaneous total knee arthroplasty in the two surgeons' bilateral TKA group, one surgeon will perform sequentially in the single surgeon bilateral TKA group. The primary outcome is to compare the incidence of PJI between the groups. Secondary, logistic regression use to estimate the effect of two surgeons bilateral TKA and single surgeon bilateral TKA on the likelihood of a patient being infected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection Joint, Joint Infection, Arthroplasty Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
413 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Two surgeon bilateral TKA group
Arm Type
Experimental
Arm Description
2 surgeons will perform simultaneous total knee arthroplasty in this group.
Arm Title
Single surgeon bilateral TKA group
Arm Type
Active Comparator
Arm Description
One surgeon will perform sequentially tptal knee arthroplasty in this group
Intervention Type
Procedure
Intervention Name(s)
Simultaneous bilateral total knee arthroplasty
Intervention Description
Two surgeon bilateral TKA group
Intervention Type
Procedure
Intervention Name(s)
Sequenced bilateral TKA
Intervention Description
Single surgeon bilateral TKA group
Primary Outcome Measure Information:
Title
Infection incedence
Description
Early infection rates
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary bilateral knee osteoarthritis with refractory to conservative treatment Patients who accept participation in the research and the randomization
Exclusion Criteria:
no history of malignancy without severe extra-articular deformities
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orkhan Aliyev
Phone
05059917419
Email
orkhanaliyev@outlook.com.tr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Infection Rate of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study
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