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

B

Bezmialem Vakif University

Status

Unknown

Conditions

Infection Joint
Arthroplasty Complications
Joint Infection

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04413565
08.12.2016-71306642-050.01.04

Details and patient eligibility

About

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.

Full 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.

Enrollment

413 estimated patients

Sex

All

Ages

18+ 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 without severe extra-articular deformities

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

413 participants in 2 patient groups

Two surgeon bilateral TKA group
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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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