Patellar Resurfacing in Total Knee Arthroplasty Leads to Better Isokinetic Performance and Higher Clinical Scores

November 18, 2020 updated by: Deniz CANKAYA, Gulhane Training and Research Hospital
For decades there have been concerns about patellar resurfacing (PR) in total knee arthroplasty (TKA) and the individual preference of the surgeon is still the main determinant of whether or not resurfacing is applied. According to preference, surgeons can be categorized in 3 main groups of those who usually, selectively or rarely resurface. The aim of this prospective, randomized, controlled study to is compare the isokinetic performance and clinical outcome of TKAs with PR and without PR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing TKA for primary osteoarthritis of the knee are randomly assigned to either the PR or non-PR groups. The differences between groups with respect to age, BMI, gender, and preoperative Knee Society Score (KSS), and isokinetic performance are evaluated. Patients are evaluated at postoperative 3, 6, and 12 months with KSS and at 6 months and 1 year with isokinetic measurements.

Study Type

Interventional

Enrollment (Actual)

50

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

  • Turkey
      • Ankara, Turkey, 06010
        • Gulhane Teaching and Research Hospital

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

55 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 55 to 80 years
  • unilateral primary osteoarthritis

Exclusion Criteria:

  • bilateral osteoarthritis
  • inflammatory arthritis
  • post-traumatic osteoarthritis
  • previous knee surgery
  • neuromuscular diseases

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: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: patellar resurfacing
patellar resurfacing in TKA
Device: patellar component
patellar resurfacing
NO_INTERVENTION: non-resurfacing
non-resurfacing TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
isokinetic test
Time Frame: Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results
isokinetic test during extension and flexion of the knee
Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Score (KSS): It has two different subscales: Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor
Time Frame: Change from preoperative KSS results at 3rd months, 6th months and 12th months KSS results
Knee Society Score (KSS)
Change from preoperative KSS results at 3rd months, 6th months and 12th months KSS results

Collaborators and Investigators

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

Sponsor

Gulhane Training and Research Hospital

Investigators

  • Principal Investigator: Deniz CANKAYA, Assoc.Professor, Gulhane Teaching and Research Hospital

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 1, 2017

Primary Completion (ACTUAL)

November 1, 2018

Study Completion (ACTUAL)

November 1, 2018

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (ACTUAL)

November 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 18, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-17-1414

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.

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