Trials / Unknown
UnknownNCT04434690
Radiologic Results of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Bezmialem Vakif University · Academic / Other
- Sex
- All
- Age
- 35 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Simultaneous bilateral total knee arthroplasty | Two surgeons bilateral TKA group |
| PROCEDURE | Sequenced bilateral TKA | Single surgeon bilateral TKA group |
Timeline
- Start date
- 2020-06-01
- Primary completion
- 2020-10-30
- Completion
- 2020-10-31
- First posted
- 2020-06-17
- Last updated
- 2020-06-17
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT04434690. Inclusion in this directory is not an endorsement.