Safety of Single-stage, Two-team, Simultaneous Bilateral Total Knee Arthroplasty Compared to One-team: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bezmialem Vakif University
- Enrollment
- 246
- Locations
- 1
- Primary Endpoint
- Number of major complications
Study Overview
Brief Summary
The effects of two-team and single-team simultaneous bilateral total knee arthroplasty (SBA) on peri- and postoperative complications are not clear. The investigators hypothesized that two-team SBA has lower early postoperative complication rates than single-surgeon SBA. Therefore, this prospective study compared minor and major complications for 90 days postoperatively between two-surgeon and single-surgeon SBA.
Detailed Description
Study Design:
This prospective randomized study was approved by our institution's Clinical Research Ethics Committee (08.11.2017-71306642-050.01.04). The protocol conforms to CONSORT guidelines for parallel-group randomized trials and the protocol is designed to conform to the principles of the Declaration of Helsinki.
Participant :
The investigators will enroll 246 patients with primary bilateral symptomatic knee osteoarthritis that was refractory to conservative treatment who underwent bilateral TKA (total knee arthroplasty) under single anaesthesia between 2017 and 2018. An informed consent form will be obtained from all patients.
The schedule for randomization was randomly generated using a computer before the initiation of the trial. Patients were randomly assigned in a 1:1 ratio. A blind medical staff member will organize the days of the surgeries of randomized patients for the two-surgeon (TS) or single-surgeon (SS) groups. Neither patients nor assessors will know about randomization results. The outcome assessor will be blinded to group allocation and will no involve in providing the interventions. The statistician performing the statistical analyses will be blinded to group allocation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •less than 75 years old
- •without severe extra-articular deformities
- •severe cardiac insufficiency and morbid obesity
- •without systemic inflammatory diseases
Arms & Interventions
Two-team SBA
Two-team simultaneous bilateral total knee arthroplasty
Intervention: Two-team simultaneous bilateral total knee arthroplasty (Procedure)
Single-team SBA
Single-team simultaneous bilateral total knee arthroplasty
Intervention: Single-team simultaneous bilateral total knee arthroplasty (Procedure)
Outcomes
Primary Outcomes
Number of major complications
Time Frame: 90 days
Systemic and local major complications will evaluate. Major complications are conditions that require long-term hospitalization and repetitive intervention.
Secondary Outcomes
- Number of minor complications(90 days)
- Estimated blood loss(1 day after operation)
- WOMAC knee score(90 days)
- Oxford Knee Score(90 days)
Investigators
Gökçer Uzer
Associate Professor
Bezmialem Vakif University