Radiologic Results of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study
1 other identifier
interventional
80
1 country
1
Brief Summary
Many surgeons and patients prefer bilateral total knee arthroplasty (TKA) under one anesthesia as single-stage administration. A single-stage bilateral TKA can be performed in two different ways: single-stage, two-team simultaneous bilateral TKA (two surgeons bilateral TKA), and single-stage, a sequential bilateral TKA (single surgeon bilateral TKA). The purpose of this study is to evaluate the radiological results in the single-stage bilateral TKA in terms of two surgeons bilateral TKA and single surgeon bilateral TKA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2020
Shorter than P25 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
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 13, 2020
CompletedFirst Posted
Study publicly available on registry
June 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2020
CompletedJune 17, 2020
June 1, 2020
5 months
June 13, 2020
June 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Radiological examination
Coronal and Sagittal Alignment
14days
Study Arms (2)
Simultaneous
EXPERIMENTAL2 surgeons will perform simultaneous total knee arthroplasty in this group.
Single surgeon bilateral TKA group
ACTIVE COMPARATOROne surgeon will perform sequentially tptal knee arthroplasty in this group
Interventions
Single surgeon bilateral TKA group
Eligibility Criteria
You may qualify if:
- Primary bilateral knee osteoarthritis with refractory to conservative treatment Patients who accept participation in the research and the randomization
You may not qualify if:
- no history of malignancy less than 75 years old without severe extra-articular deformities severe cardiac insufficiency and morbid obesity without systemic inflammatory diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bezmialem Vakif University
Istanbul, Fatih, 34000, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Resident Doctor in Orthopaedic Surgery
Study Record Dates
First Submitted
June 13, 2020
First Posted
June 17, 2020
Study Start
June 1, 2020
Primary Completion
October 30, 2020
Study Completion
October 31, 2020
Last Updated
June 17, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share