Comparative Study Between Patellar Denervation and Non-patellar Denervation in Total Knee Arthroplasty With Patellar Resurfacing

November 20, 2020 updated by: Satit Thiengwittayaporn, Navamindradhiraj University

Patellar Denervation in Total Knee Arthroplasty With Patellar Resurfacing to Relieve Postoperative Anterior Knee Pain: a Randomized Control Trial

The purpose of this study is to compare the post-operative anterior knee pain (AKP) between patellar denervation and non-patellar denervation in total knee arthroplasty with patellar resurfacing

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

241

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

  • ADULT
  • OLDER_ADULT
  • CHILD

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Patellar denervation
Procedure: Total knee arthroplasty
A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)
Procedure: Patellar denervation
circumpatellar electrocautery with monopolar coagulation diathermy
EXPERIMENTAL: Non-patellar denervation
Procedure: Total knee arthroplasty
A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)

What is the study measuring?

Primary 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
range of motion of knee
Time Frame: Change from baseline range of motion of knee at 3 months, 6 months, and 12 months after surgery
degree of motion of the knee after surgery
Change from baseline range of motion of knee at 3 months, 6 months, and 12 months after surgery
New patellar score (Bartlett score)
Time Frame: Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery
New patellar score or Bartlett score (minimum 0, maximum 30)
Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery
patellar shift index
Time Frame: Change from baseline 3 months, 6 months, and 12 months after surgery
The estimation of patellar position relative to the trochear
Change from baseline 3 months, 6 months, and 12 months after surgery
prevalence of anterior knee pain
Time Frame: Change from baseline prevalence of anterior knee pain at 3 months, 6 months, and 12 months after surgery
Percent of anterior knee pain
Change from baseline prevalence of anterior knee pain at 3 months, 6 months, and 12 months after surgery
activity of daily living
Time Frame: Change from baseline activity of daily living at 3 months, 6 months, and 12 months after surgery
activity of daily living score (minimum 0, maximum 20)
Change from baseline activity of daily living at 3 months, 6 months, and 12 months after surgery
post-operative complication
Time Frame: Number and type of post-operative complication at 3 months, 6 months, and 12 months after surgery
Number and type of post-operative complication
Number and type of post-operative complication at 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)

December 21, 2017

Primary Completion (ACTUAL)

August 15, 2020

Study Completion (ACTUAL)

August 20, 2020

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

December 27, 2017

First Posted (ACTUAL)

January 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • COA 147/2560

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.

Yes

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.

Clinical Trials on Patellar Resurfacing

Clinical Trials on Total knee arthroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe