Comparison of Vibration Arthrometry Between Patella Resurfacing and Patella Non-resurfacing in Total Knee Replacement Patients

January 4, 2019 updated by: Satit Thiengwittayaporn, Navamindradhiraj University

Prospective Randomized Controlled Trial: Comparison of Vibration Arthrometry Between Patella Resurfacing and Patella Non-resurfacing in Total Knee Replacement Patients

Patellar crepitus is a complication of total knee arthroplasty (TKA).The development of patellar crepitus after TKA are related to many factors such as femoral component design, surgical errors, and postoperative patellar baja. However, it is unclear whether patella resurfacing or patella non-resurfacing are associate with patellar crepitus. The primary objective of this study are to compare the prevalence of patellar crepitus and the mean value of vibroacoustic signal between patellar-resurfacing and patellar non-resurfacing in TKA. The secondary objective is to study the association between patellar crepitus and vibroacoustic signal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Dusit, Bangkok, Thailand, 10300
        • Navamindradhiraj University

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary osteoarthritis of knee

Exclusion Criteria:

  • rheumatoid arthritis
  • morbid obesity
  • severe patellofemoral joint destruction
  • patella maltracking
  • patellofemoral incongruent
  • inflammatory arthritis
  • refuse to participation

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patellar resurfacing
patellar resurfacing TKA
Procedure: patellar resurfacing
patellar component insert with cement
No Intervention: patellar non-resurfacing
patellar non-resurfacing TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of patellar crepitus
Time Frame: pre-op, 3, 6 month
patellar crepitus investigate by physical examination
pre-op, 3, 6 month
change of mean of vibroacoustic signal
Time Frame: pre-op, 3, 6 month
pre-op, 3, 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patellar crepitus related to mean of vibroacoustic signal
Time Frame: pre-op, 3, 6 month
study the association between patellar crepitus and vibroacoustic signal, patellar crepitus investigate by physical examination and mean of vibroacoustic signal assessed by an acceleration sensor
pre-op, 3, 6 month

Collaborators and Investigators

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

Sponsor

Navamindradhiraj University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2016

Primary Completion (Actual)

December 15, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

December 10, 2016

First Submitted That Met QC Criteria

December 19, 2016

First Posted (Estimate)

December 20, 2016

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • COA113/2559

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

product manufactured in and exported from the U.S.

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.

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