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

Anderson Orthopaedic Research Institute142 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

142

Conditions

Knee Osteoarthritis

Interventions

Rotating Platform High-Flex Cruciate Substituting TKADEVICE

Rotating Platform Cruciate Substituting TKADEVICE

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Preoperative, 4-6 weeks

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.

Time frame: 4-6 months

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.

Time frame: 1 year

Secondary Outcomes

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.

Time frame: preoperative, 4-6 weeks

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.

Time frame: 1 year

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.

Time frame: 1 year

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.

Data from ClinicalTrials.gov

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