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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
patellar component
Sponsored by
Gulhane Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring patellar resurfacing, isokinetic testing

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gulhane Teaching and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

patellar resurfacing

non-resurfacing

Arm Description

patellar resurfacing in TKA

non-resurfacing TKA

Outcomes

Primary Outcome Measures

isokinetic test
isokinetic test during extension and flexion of the knee

Secondary Outcome Measures

Knee Society Score (KSS): It has two different subscales: Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor
Knee Society Score (KSS)

Full Information

First Posted
November 9, 2020
Last Updated
November 18, 2020
Sponsor
Gulhane Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04637490
Brief Title
Patellar Resurfacing in Total Knee Arthroplasty Leads to Better Isokinetic Performance and Higher Clinical Scores
Official Title
Patellar Resurfacing in Total Knee Arthroplasty Leads to Better Isokinetic Performance and Higher Clinical Scores
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulhane Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
patellar resurfacing, isokinetic testing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patellar resurfacing
Arm Type
Experimental
Arm Description
patellar resurfacing in TKA
Arm Title
non-resurfacing
Arm Type
No Intervention
Arm Description
non-resurfacing TKA
Intervention Type
Device
Intervention Name(s)
patellar component
Intervention Description
patellar resurfacing
Primary Outcome Measure Information:
Title
isokinetic test
Description
isokinetic test during extension and flexion of the knee
Time Frame
Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results
Secondary Outcome Measure Information:
Title
Knee Society Score (KSS): It has two different subscales: Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor
Description
Knee Society Score (KSS)
Time Frame
Change from preoperative KSS results at 3rd months, 6th months and 12th months KSS results

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz CANKAYA, Assoc.Professor
Organizational Affiliation
Gulhane Teaching and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gulhane Teaching and Research Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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