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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

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