NCT04299516

Brief Summary

The effects of two-team and single-team simultaneous bilateral total knee arthroplasty (SBA) on peri- and postoperative complications are not clear. The investigators hypothesized that two-team SBA has lower early postoperative complication rates than single-surgeon SBA. Therefore, this prospective study compared minor and major complications for 90 days postoperatively between two-surgeon and single-surgeon SBA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 8, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

March 4, 2020

Last Update Submit

March 5, 2020

Conditions

Bilateral Total Knee ArthroplastyGonarthrosis; Primary, Bilateral

Keywords

total knee arthroplastycomplicationsafetyoperative time

Outcome Measures

Primary Outcomes (1)

  • Number of major complications

    Systemic and local major complications will evaluate. Major complications are conditions that require long-term hospitalization and repetitive intervention.

    90 days

Secondary Outcomes (4)

  • Number of minor complications

    90 days

  • WOMAC knee score

    90 days

  • Oxford Knee Score

    90 days

  • Estimated blood loss

    1 day after operation

Study Arms (2)

Two-team SBA

EXPERIMENTAL

Two-team simultaneous bilateral total knee arthroplasty

Procedure: Two-team simultaneous bilateral total knee arthroplasty

Single-team SBA

ACTIVE COMPARATOR

Single-team simultaneous bilateral total knee arthroplasty

Procedure: Single-team simultaneous bilateral total knee arthroplasty

Interventions

Two-team simultaneous bilateral total knee arthroplastyPROCEDURE

Bilateral total knee arthroplasty can be performed in three different ways: single-stage, two-team simultaneous bilateral total knee arthroplasty; single-stage, one-surgeon, and two-stage bilateral total knee arthroplasty. Two surgeons will operate simultaneously on one side for two-team SBA.

Two-team SBA
Single-team simultaneous bilateral total knee arthroplastyPROCEDURE

One surgeon will operate sequentially on both sides for one-surgeon SBA

Single-team SBA

Eligibility Criteria

Age40 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
  • without severe extra-articular deformities
  • severe cardiac insufficiency and morbid obesity
  • without systemic inflammatory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34000, Turkey (Türkiye)

Location

Related Publications (1)

  • Uzer G, Aliyev O, Yildiz F, Gungoren N, Elmali N, Tuncay I. Safety of one-stage bilateral total knee arthroplasty -one surgeon sequential vs. two surgeons simultaneous: a randomized controlled study. Int Orthop. 2020 Oct;44(10):2009-2015. doi: 10.1007/s00264-020-04704-9. Epub 2020 Jul 10.

    PMID: 32651711DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 6, 2020

Study Start

November 8, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)