Incidence of Patellar Crepitus in Removal and Non-removal of Fibrosynovial Tissue at Superior Pole of Patella

August 30, 2021 updated by: Satit Thiengwittayaporn, Navamindradhiraj University

Prospective Randomized Controlled Trial: Comparison of Incidence of Patellar Crepitus Between Removal and Non-removal of Fibrosynovial Tissue at the Border of the Superior Pole of the Patellar

The purpose of this study is to compare the incidence of patellar crepitus complication and the clinical outcome between remove and not remove fibrosynovial tissue at the border of the superior pole of the patellar in posterior stabilized total knee arthroplasty.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

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 who were scheduled for a primary total knee arthroplasty

Exclusion Criteria:

  • Valgus deformity
  • History of inflammatory arthroplathy
  • Previous fracture or open surgery on the same knee
  • History of patellar instability

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: Removal of fibrosynovial tissue
Removal of fibrosynovial tissue in patellar non-resurfacing TKA
Procedure: Removal of fibrosynovial tissue
Remove of fibrosynovial tissue at the superior border of patella
Experimental: Non-removal of fibrosynovial tissue
Non-removal of fibrosynovial tissue in patellar non-resurfacing TKA
Procedure: Non-removal of fibrosynovial tissue
Do not remove of fibrosynovial tissue at the superior border of patella

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of patellar crepitus complication
Time Frame: Change from baseline patellar crepitus complication 3 months, 6 months, and 12 months after surgery
Incidence of patellar crepitus complication (present, absent)
Change from baseline patellar crepitus complication 3 months, 6 months, and 12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of post-operative anterior knee pain
Time Frame: Change from baseline Visual Analog Scale for anterior knee pain at 3 months, 6 months, and 12 months after surgery
Visual Analog Scale for anterior knee pain (minimum 0, maximum 10) Do higher values represent a worse outcome
Change from baseline Visual Analog Scale for anterior knee pain at 3 months, 6 months, and 12 months after surgery
Knee Society and Knee Society function score
Time Frame: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery
Knee Society and Knee Society function score (minimum 0, maximum 200)
Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery
New patellar score
Time Frame: Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery
New patellar score (minimum 0, maximum 30)
Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery
Oxford knee score
Time Frame: Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery
Oxford knee score (minimum 0, maximum 48)
Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery

Collaborators and Investigators

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

Sponsor

Navamindradhiraj 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)

June 10, 2020

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • COA 057/2563

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.

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