Radiologic Results of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study

Bezmialem Vakif University

Status: Unknown

Conditions: Gonarthrosis; Primary

Treatments: Procedure: Simultaneous bilateral total knee arthroplasty; Procedure: Sequenced bilateral TKA

Study type: Interventional

Funder types: Other

Identifiers

NCT04434690

71306642-050.01.04

Details and patient eligibility

About

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.

Full description

Investigators will enroll 136 participants with primary bilateral symptomatic knee osteoarthritis that will refractory to conservative treatment who will undergo bilateral TKA under single anaesthesia after 15.06.2020. Investigators will include patients who were less than 75 years old, with no history of malignancy, without severe extra-articular deformities, and without the systemic inflammatory disease, severe cardiac insufficiency, and morbid obesity (>40 kg/m2 or 35 or more and experiencing obesity-related health conditions). An informed consent form will be obtained from all patients.

Enrollment: 80 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups

Simultaneous

Experimental group

Description:

2 surgeons will perform simultaneous total knee arthroplasty in this group.

Treatment:

Procedure: Simultaneous bilateral total knee arthroplasty

Single surgeon bilateral TKA group

Active Comparator group

Description:

One surgeon will perform sequentially tptal knee arthroplasty in this group

Treatment:

Procedure: Sequenced bilateral TKA