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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: Rotating Platform High-Flex Cruciate Substituting TKA; Device: Rotating Platform Cruciate Substituting TKA

• Registration Number: NCT01176292
• Lead Sponsor: Anderson Orthopaedic Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-08-05
• Study First Posted: 2010-08-06
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2013-07-23
• Results First Submitted QC: 2015-07-31
• Results First Posted: 2015-08-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotating Platform High-Flex Cruciate Substituting TKA	Rotating Platform High-Flex Cruciate Substituting TKA	-
Rotating Platform Cruciate Substituting TKA	Rotating Platform Cruciate Substituting TKA	-

Primary Outcome Measures

Name	Time	Method
Clinical Flexion	1 year	Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.

Secondary Outcome Measures

Name	Time	Method
Oxford Knee Score	1 year	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.
Radiographic Flexion	1 year	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.
Knee Society Score (KSS)	1 year	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.