NCT04367272

Brief Summary

The effects of single-team simultaneous bilateral total knee arthroplasty on peri- and postoperative complications are clear. The investigators hypothesized that second knee at risk during single-team simultaneous bilateral total knee arthroplasty and have more early postoperative complication rates than the first knee. Therefore, this prospective study compared minor and major local complications for 90 days postoperatively between the first and second during knee single-team simultaneous bilateral total knee arthroplasty.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

April 25, 2020

Last Update Submit

April 29, 2020

Conditions

Osteoarthritis, KneeInfectionPeriprosthetic Fracture Around Prosthetic Joint Implant

Outcome Measures

Primary Outcomes (1)

  • Local complications

    Local operation related complications rate

    90 days

Study Arms (2)

First Knee

ACTIVE COMPARATOR

The first knee is the knee where the surgery will begin to be applied.

Procedure: First Arthroplasty

Second Knee

EXPERIMENTAL

The second knee is the knee where the surgeon will apply secondly.

Procedure: Second Arthroplasty

Interventions

First ArthroplastyPROCEDURE

First Knee

First Knee
Second ArthroplastyPROCEDURE

Second Knee

Second Knee

Eligibility Criteria

Age18 Years - 75 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
  • less than 75 years old
  • severe cardiac insufficiency and morbid obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneeInfections

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Orkhan Aliyev, MD

CONTACT

+905059917419orkhanaliyev@outlook.com.tr

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
Residents Doctor in Orthopedics Department, Principal Investigator

Study Record Dates

First Submitted

April 25, 2020

First Posted

April 29, 2020

Study Start

May 15, 2020

Primary Completion

May 15, 2021

Study Completion

June 30, 2021

Last Updated

April 30, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR