NCT04419129

Brief Summary

The total knee replacement (TKA) has shown excellent survival. However, some patients were up to 20%, they still had pain and make them dissatisfy after operation. The medial unicompartmental knee arthroplasty (UKA) also has shown excellent survivorship. The patient who underwent UKA fell like normal knee because restoring natural kinematic and biomechanic compare to TKA. However, The previous studies did not include the same characteristic of patient in their studies. Therefor, UKA should be better than TKA. This study will compare TKA to mobile bearing medial UKA or Oxford medial UKA. The mobile bearing UKA is different to fixed bearing UKA. The mobile bearing UKA will be back knee alignment to pre-disease stage, restore knee stability and restore natural knee kinematic and biomechanic. Therefore, patients who underwent mobile bearing UKA will feel like normal knee and restore function to near or nearly normal. The measurement of clinical outcome after knee arthroplasty is questionable. The self-report questionnaire was used in the past. However, this score can not estimate the true function of patients. The patient have shown high score, but they still had pain and did not show satisfy after operation.The performance-based test such as 2-minute walk test (2MWT), 6-minute walk test (6MWT) and Timed get-up-and-go test (TUG) should show the exactly clinical outcome of patient following knee arthroplasty compare to self-report questionnaire. Today, no randomized controlled trial study to compare performance-based test between TKA and mobile bearing UKA. Therefor, this study will compare 2MWT and TUG between TKA and mobile bearing UKA in medial OA knee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 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

First Submitted

Initial submission to the registry

May 28, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
3 years until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

3.5 years

First QC Date

May 28, 2017

Last Update Submit

August 29, 2021

Conditions

Patient Reported Outcome Measure

Outcome Measures

Primary Outcomes (2)

  • 2 minutes walk test (2MWT)

    measurement of endurance that assesses walking distance over 2 minutes

    2 years

  • time up and go test (TUG)

    It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.

    2 years

Secondary Outcomes (4)

  • Knee Society Score

    2 years

  • Oxford knee score

    2 years

  • Forgotten Joint Score

    2 years

  • Kujala score

    2 years

Study Arms (2)

Mobile bearing unicompartmental knee arthroplasty

ACTIVE COMPARATOR

50 mobile bearing UKA

Device: Oxford UKA

posterior stabilized fixed bearing total knee arthroplasty

ACTIVE COMPARATOR

50 posterior stabilized fixed bearing cemented total knee arthroplasty

Device: Vanguard TKA

Interventions

Oxford UKADEVICE

knee arthroplasty

Mobile bearing unicompartmental knee arthroplasty
Vanguard TKADEVICE

knee arthroplasty

posterior stabilized fixed bearing total knee arthroplasty

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • anteromedial OA knee

You may not qualify if:

  • varus deformity \> 15 degrees
  • ROM \< 90 degrees
  • fixed varus deformity
  • post-traumatic arthritis
  • inflammatory arthritis
  • anterior cruciate ligament insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boonchana Pongcharoen

Pathum Thani, 12120, Thailand

Location

Related Publications (1)

  • Pongcharoen B, Liengwattanakol P, Boontanapibul K. Comparison of Functional Recovery Between Unicompartmental and Total Knee Arthroplasty: A Randomized Controlled Trial. J Bone Joint Surg Am. 2023 Feb 1;105(3):191-201. doi: 10.2106/JBJS.21.00950. Epub 2022 Dec 21.

    PMID: 36542689DERIVED

Study Officials

  • Boonchana Pongcharoen, MD

    faculty of medicine, Thammasat university

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 28, 2017

First Posted

June 5, 2020

Study Start

June 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)