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

November 4, 2020 updated by: William G. Hamilton, MD, Anderson Orthopaedic Research Institute

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Rotating Platform High-Flex Cruciate Substituting TKA
Device: Rotating Platform High-Flex Cruciate Substituting TKA
OTHER: Rotating Platform Cruciate Substituting TKA
Device: Rotating Platform Cruciate Substituting TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Flexion
Time Frame: Preoperative, 4-6 weeks
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
Clinical Flexion
Time Frame: 4-6 months
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
Clinical Flexion
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Flexion
Time Frame: preoperative, 4-6 weeks
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
Radiographic Flexion
Time Frame: 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.
1 year
Knee Society Score (KSS)
Time Frame: 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.
1 year
Oxford Knee Score
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anderson Orthopaedic Research Institute

Collaborators

DePuy Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

July 26, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (ESTIMATE)

August 6, 2010

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AORI2010-0104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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