Comparison of Removing and Non-removing Patellofemoral Joint Osteophytes Following Medial Unicompartment Knee Arthroplasty

May 4, 2022 updated by: Boonchana Pongcharoen, Thammasat University

Does Removing Patellofemoral Joint Osteophytes Reduce Anterior Knee Pain Following Unicompartment Knee Arthroplasty?

Background: Anterior knee pain (AKP) is a challenge following unicompartmental knee arthroplasty (UKA). Some surgeons remove patellofemoral joint (PFJ) osteophytes to reduce osteophyte impingement and AKP. However, there is evidence that PFJ osteophytes compensate for knee osteoarthritis (OA) by increasing and improving stability and increase contract surface area in knee osteoarthritis. Moreover, when PFJ osteophytes are not removed, some studies report good clinical outcomes. The issue of removing or leaving PFJ osteophytes is controversial.

The objective of this study was to compare AKP following mobile bearing UKA after removing or leaving PFJ osteophytes.

Methods: The prospective non-randomized study included 89 isolated medial osteoarthritis (OA) of knee. They were classified into 2 groups. Group (Gp)1 was removing PFJ osteophytes; consists of 44 knees. Gp2 was non-removing PFJ osteophytes: consists of 45 knees. The patients were follow up and recorded incidence of AKP and VAS for AKP at 6 weeks, 3months, 6 months, 1 year and 2 years. No patients were lost to follow up. The patellar tilt and shift were measured at 6 weeks, 3months, 6months, 1year and 2 years via skyline view radiography. The knee society scores, Oxford knee score, knee injury and osteoarthritis outcome score, forgotten joint score and Kujala scale also were recorede at 6 weeks, 3months, 6months, 1 year and 2 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Removing and non-removing osteophyte at patellofemoral joint is controversial topic. The osteophyte may help to reduce load and improve stability of patellofemoral joint. Therefore, the purpose of this study is to compared anterior knee pain between removing and non-removing osteophyte at patellofemoral joint following medial mobile bearing unicompartmental knee arthroplasty

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

43 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

isolated medial osteoarthritis of the knee

Description

Inclusion Criteria:

  • age > 42 years old
  • range of motion > 90 degrees
  • flexion contracture< 15 degrees
  • normal function of anterior cruciate ligament

Exclusion Criteria:

  • spontaneous osteonecrosis of the knee
  • inflammatory joinr arthritis
  • full thickness cartilage loss at lateral compartment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
removing patellofemoral joint osteophytes
remove osteophyte at patella, medial femoral condyle and lateral femoral condyle
Procedure: removing osteophyte at patellofemoral joint
to compare anterior knee pain between removing patellofemoral joint osteophytes and non-removing patellofemoral joint osteophytes after medial unicompartmental knee arthroplasty
non-removing patellofemoral joint osteophytes
no remove osteophyte at patella, medial femoral condyle and lateral femoral condyle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
incidence of anterior knee pain
Time Frame: 6 weeks
number of participant that had anterior knee pain
6 weeks
incidence of anterior knee pain
Time Frame: 3 months
number of participant that had anterior knee pain
3 months
incidence of anterior knee pain
Time Frame: 6 months
number of participant that had anterior knee pain
6 months
incidence of anterior knee pain
Time Frame: 1 year
number of participant that had anterior knee pain
1 year
incidence of anterior knee pain
Time Frame: 2 year
number of participant that had anterior knee pain
2 year
Visual analogue scale for anterior knee pain
Time Frame: 6 weeks
pain score 0= no pain and pain score 10= maximum pain
6 weeks
Visual analogue scale for anterior knee pain
Time Frame: 3 months
pain score 0= no pain and pain score 10= maximum pain
3 months
Visual analogue scale for anterior knee pain
Time Frame: 6 months
pain score 0= no pain and pain score 10= maximum pain
6 months
Visual analogue scale for anterior knee pain
Time Frame: 1 year
pain score 0= no pain and pain score 10= maximum pain
1 year
Visual analogue scale for anterior knee pain
Time Frame: 2 years
pain score 0= no pain and pain score 10= maximum pain
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thammasat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MTU-EC-OT-0-224/62

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings