NCT04968600

Brief Summary

In total knee arthroplasty (TKA), the posterior-cruciate ligament-retaining (CR) and posterior-cruciate-ligament stabilized (PS) techniques are widely used depending on the individual preference of the surgeon. Comparative analysis of these two techniques is a major topic of investigation in arthroplasty research. The hypothesis of the present study is that compared with the CR technique, the PS technique is associated with a worse gait pattern. Smart-phone based gait analysis and patient-reported functional outcomes are evaluated in patients undergoing total knee arthroplasty with a CR and a PS technique, 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
86

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable knee-osteoarthritis

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

April 28, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 20, 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 20, 2021

Status Verified

July 1, 2021

Enrollment Period

1.8 years

First QC Date

July 5, 2021

Last Update Submit

July 8, 2021

Conditions

Knee Osteoarthritis

Keywords

knee arthroplastygait analysissmart-phone

Outcome Measures

Primary Outcomes (3)

  • smart-phone based gait analysis

    Gait analysis 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 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 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)

Posterior-cruciate-ligament-retaining (CR)

EXPERIMENTAL

Posterior-cruciate-ligament-retaining (CR) technique of total knee arthroplasty

Procedure: total knee arthroplasty

posterior-cruciate-ligament-stabilized (PS)

EXPERIMENTAL

Posterior-cruciate-ligament-retaining (CR) technique of total knee arthroplasty

Procedure: total knee arthroplasty

Interventions

total knee arthroplastyPROCEDURE

Posterior-cruciate-ligament is retained in one arm and sacrificed in another arm during total knee arthroplasty

Posterior-cruciate-ligament-retaining (CR)posterior-cruciate-ligament-stabilized (PS)

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of unilateral 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
  • Bilateral 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

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Deniz CANKAYA, Assoc.Prof.

    Gulhane Teaching and Research Hospital

    STUDY CHAIR

  • Denizhan SIVRI, MD

    Gulhane Teaching and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deniz CANKAYA, Assoc.Prof.

CONTACT

+90 542 6688056cankayadeniz78@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double (Participant, Investigator)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 20, 2021

Study Start

April 28, 2021

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

July 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)