NCT02557763

Brief Summary

The aims of this study is to compare the results between patients without severe patellofemoral arthritis and patients with severe patellofemoral arthritis after mobile bearing UKA. The investigators prospective compute the results including anterior knee pain, knee society score, pain score, functional score, range of motion, operative time, blood loss, and component alignment.

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 Jan 2011

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

4.2 years

First QC Date

May 7, 2015

Last Update Submit

August 29, 2021

Conditions

Keywords

Oxford UKAanterior knee painlateral facet of patella

Outcome Measures

Primary Outcomes (1)

  • visual analog scale for anterior knee pain

    The 10-point visual analog scale is 0 representing no pain and 10 representing maximum pain experience.

    1 year

Secondary Outcomes (1)

  • Knee society score

    1year

Study Arms (2)

Severe PF arthritis

EXPERIMENTAL

Oxford unicompartmental knee arthroplasty is partial knee replacement. Oxford unicompartmental knee arthroplasty is applied for medial compartmental of knee.

Device: Oxford unicompartmental knee arthroplasty

non severe PF arthritis

EXPERIMENTAL

Oxford unicompartmental knee arthroplasty is partial knee replacement. Oxford unicompartmental knee arthroplasty is applied for medial compartmental of knee.

Device: Oxford unicompartmental knee arthroplasty

Interventions

The patients with medial osteoarthritis knee with patellofemoral arthritis were performed surgery and applied Oxford unicompartmental knee arthroplasty.

Also known as: Oxford UKA
Severe PF arthritisnon severe PF arthritis

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • anteromedial osteoarthritis knee,
  • older than 40 years old,
  • range of motion \> 90 degrees,
  • varus deformity \< 25degrees,
  • flexion contracture\< 20degrees,
  • intact anterior cruciate ligament

You may not qualify if:

  • younger than 40,
  • osteonecrosis of knee,
  • rheumatoid,
  • posttraumatic arthritis,
  • absent of anterior cruciate ligament

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boonchana Pongcharoen

Pathum Thani, Changwat Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Boonchana Pongcharoen, MD

    Thammasat University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON 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
Associate Professor

Study Record Dates

First Submitted

May 7, 2015

First Posted

September 23, 2015

Study Start

January 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

September 2, 2021

Record last verified: 2021-08

Locations