NCT04413565

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
413

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2016

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

4 years

First QC Date

May 29, 2020

Last Update Submit

May 29, 2020

Conditions

Infection JointJoint InfectionArthroplasty Complications

Outcome Measures

Primary Outcomes (1)

  • Infection incedence

    Early infection rates

    90 days

Study Arms (2)

Two surgeon bilateral TKA group

EXPERIMENTAL

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

Procedure: Simultaneous bilateral total knee arthroplasty

Single surgeon bilateral TKA group

ACTIVE COMPARATOR

One surgeon will perform sequentially tptal knee arthroplasty in this group

Procedure: Sequenced bilateral TKA

Interventions

Simultaneous bilateral total knee arthroplastyPROCEDURE

Two surgeon bilateral TKA group

Two surgeon bilateral TKA group
Sequenced bilateral TKAPROCEDURE

Single surgeon bilateral TKA group

Single surgeon bilateral TKA group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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 without severe extra-articular deformities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34000, Turkey (Türkiye)

RECRUITING

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

May 29, 2020

First Posted

June 4, 2020

Study Start

December 8, 2016

Primary Completion

November 30, 2020

Study Completion

December 31, 2020

Last Updated

June 4, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)