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NCT04637490 Clinical Trial

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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04637490
Other study ID # E-17-1414
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date November 1, 2018

Study information
Verified date November 2020
Source Gulhane Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date November 1, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers No
Gender All
Age group 55 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• patellar component
patellar resurfacing

Locations
Country Name City State
Turkey Gulhane Teaching and Research Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Gulhane Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary isokinetic test 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 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) Change from preoperative KSS results at 3rd months, 6th months and 12th months KSS results
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