NCT04975165

Brief Summary

Total knee arthroplasty is a well-known treatment of the end-stage osteoarthritis of the knee. In the case of bilateral end-stage knee osteoarthritis, both of the knees need total knee arthroplasty. Bilateral total knee arthroplasty could be performed simultaneously or staged according to the preference of the patients. Simultaneous total knee arthroplasty is defined as the replacement of both knees in a single surgery. The major advantage of simultaneous total knee arthroplasty this surgery is that it requires only one hospital stay and a rehabilitation period to recover both knees, but higher blood transfusion rates and thromboembolism risk are still major concerns. Therefore, in this comparative study, smart-phone based gait analysis and patient-reported functional outcomes are evaluated in patients undergoing simultaneous and staged total knee arthroplasty, at 3, 6, and 12 months postoperatively

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
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

1.7 years

First QC Date

July 21, 2021

Last Update Submit

July 22, 2021

Conditions

Bilateral Knee Osteoarthritis

Keywords

Bilateral knee arthroplastyGait analysisSmart-phone

Outcome Measures

Primary Outcomes (3)

  • smart-phone based gait analysis

    Gait analysis (The gait velocity, step time (ST), step length (SL), cadence, step length symmetry and step time symmetry) is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application

    Change from preoperative gait analysis at 3rd month gait analysis

  • smart-phone based gait analysis

    Gait analysis (The gait velocity, step time (ST), step length (SL), cadence, step length symmetry and step time symmetry) is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application

    Change from 3rd month gait analysis at 6th month gait analysis

  • smart-phone based gait analysis

    Gait analysis (The gait velocity, step time (ST), step length (SL), cadence, step length symmetry and step time symmetry) is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application

    Change from 6th month gait analysis at 12th month gait analysis

Secondary Outcomes (3)

  • Knee functional scores

    Change from preoperative Knee Society Scores (KSS) at 3rd month Knee Society Score (KSS)

  • Knee functional scores

    Change from 3rd month Knee Society Scores (KSS) at 6th month Knee Society Score (KSS)

  • Knee functional scores

    Change from 6th month Knee Society Scores (KSS) at 12th month Knee Society Score (KSS)

Study Arms (2)

Staged total knee arthroplasty

EXPERIMENTAL

Staged replacement of both knees in two separate surgeries.

Procedure: Total knee arthroplasty

Simultaneous total knee arthroplasty

EXPERIMENTAL

Simultaneous replacement of both knees in a single surgery.

Procedure: Total knee arthroplasty

Interventions

Total knee arthroplastyPROCEDURE

Bilateral surgery in one arm and staged surgery in another arm during total knee arthroplasty

Simultaneous total knee arthroplastyStaged total knee arthroplasty

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of bilateral primary knee osteoarthritis Age 55 to 85 years Must be able to walk without support

You may not qualify if:

  • Rheumatological joint diseases Previous knee surgery Neuromuscular diseases Unilateral knee osteoarthritis Insufficiency of knee collateral ligaments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Teaching and Research Hospital

Ankara, 06010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Deniz CANKAYA, Assoc.Prof.

    Gulhane Teaching and Research Hospital

    STUDY CHAIR

Central Study Contacts

Deniz Cankaya, Assoc.Prof.

CONTACT

+90 542 6688056cankayadeniz78@gmail.com

Anıl Ozgur, MD

CONTACT

+90 554 3281193dr.anilozgur@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Professor

Study Record Dates

First Submitted

July 21, 2021

First Posted

July 23, 2021

Study Start

May 26, 2021

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

July 29, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)