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

NCT ID: NCT01176292

Last Updated: 2020-11-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Knee Osteoarthritis

Keywords

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total knee replacement high flexion range of motion rotating platform TKA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Rotating Platform High-Flex Cruciate Substituting TKA

Group Type OTHER

Rotating Platform High-Flex Cruciate Substituting TKA

Intervention Type DEVICE

Rotating Platform Cruciate Substituting TKA

Group Type OTHER

Rotating Platform Cruciate Substituting TKA

Intervention Type DEVICE

Interventions

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Rotating Platform High-Flex Cruciate Substituting TKA

Intervention Type DEVICE

Rotating Platform Cruciate Substituting TKA

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DePuy Orthopaedics

INDUSTRY

Sponsor Role collaborator

Anderson Orthopaedic Research Institute

OTHER

Sponsor Role lead

Responsible Party

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William G. Hamilton, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William G Hamilton, MD

Role: PRINCIPAL_INVESTIGATOR

Anderson Orthopaedic Research Institute

Other Identifiers

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AORI2010-0104

Identifier Type: -

Identifier Source: org_study_id