Comparison of High Flex and Standard Rotating Platform Total Knee Arthroplasty (TKA)

Knee Osteoarthritis Clinical Trial

Official title:

A Prospective Comparison of Rotating Platform Cruciate Substituting Total Knee Arthroplasty With Rotating Platform High-Flex Cruciate Substituting Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176292
• Other study ID #: AORI2010-0104
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Est. completion date: May 2012

Study information

• Verified date: November 2020
• Source: Anderson Orthopaedic Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform TKA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 40 to 75 years old
• Primary diagnosis of osteoarthritis of the knee
• Patients who, in the investigator's opinion, are appropriate candidates for a cemented, rotating platform TKA.
• Patients who, in the investigator's opinion, are capable of participation in a clinical trial and reliable enough to return for follow-up appointments.

Exclusion Criteria:

• Pregnant or lactating female subjects
• Patients with post-traumatic or inflammatory arthritis
• Patients with a fixed flexion contracture of greater than 20 degrees
• Patients with advanced hip, spine, or ankle disease
• Patients with a BMI greater than 40, where knee flexion may be limited by soft tissues

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Rotating Platform High-Flex Cruciate Substituting TKA

• Rotating Platform Cruciate Substituting TKA

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Anderson Orthopaedic Research Institute	DePuy Orthopaedics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Flexion	Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.	Preoperative, 4-6 weeks
Primary	Clinical Flexion	Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.	4-6 months
Primary	Clinical Flexion	Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.	1 year
Secondary	Radiographic Flexion	Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.	preoperative, 4-6 weeks
Secondary	Radiographic Flexion	Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.	1 year
Secondary	Knee Society Score (KSS)	A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. The minimum score is 0 and the highest score is 100. A higher score represents a better outcome.	1 year
Secondary	Oxford Knee Score	A patient reported questionnaire for assessing the outcome of knee surgery. The minimum score is 0 and the maximum score is 48. A higher score represents a better outcome.	1 year