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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rotating Platform High-Flex Cruciate Substituting TKA
Rotating Platform Cruciate Substituting TKA
Sponsored by
Anderson Orthopaedic Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring total knee replacement, high flexion, range of motion, rotating platform, TKA

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Rotating Platform High-Flex Cruciate Substituting TKA

    Rotating Platform Cruciate Substituting TKA

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.

    Full Information

    First Posted
    July 26, 2010
    Last Updated
    November 4, 2020
    Sponsor
    Anderson Orthopaedic Research Institute
    Collaborators
    DePuy Orthopaedics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01176292
    Brief Title
    Comparison of High Flex and Standard Rotating Platform Total Knee Arthroplasty (TKA)
    Official Title
    A Prospective Comparison of Rotating Platform Cruciate Substituting Total Knee Arthroplasty With Rotating Platform High-Flex Cruciate Substituting Total Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2007 (undefined)
    Primary Completion Date
    May 2012 (Actual)
    Study Completion Date
    May 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Anderson Orthopaedic Research Institute
    Collaborators
    DePuy Orthopaedics

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    total knee replacement, high flexion, range of motion, rotating platform, TKA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    142 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rotating Platform High-Flex Cruciate Substituting TKA
    Arm Type
    Other
    Arm Title
    Rotating Platform Cruciate Substituting TKA
    Arm Type
    Other
    Intervention Type
    Device
    Intervention Name(s)
    Rotating Platform High-Flex Cruciate Substituting TKA
    Intervention Type
    Device
    Intervention Name(s)
    Rotating Platform Cruciate Substituting TKA
    Primary Outcome Measure Information:
    Title
    Clinical Flexion
    Description
    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
    Title
    Clinical Flexion
    Description
    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
    Title
    Clinical Flexion
    Description
    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 Outcome Measure Information:
    Title
    Radiographic Flexion
    Description
    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
    Title
    Radiographic Flexion
    Description
    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
    Title
    Knee Society Score (KSS)
    Description
    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
    Title
    Oxford Knee Score
    Description
    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.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    William G Hamilton, MD
    Organizational Affiliation
    Anderson Orthopaedic Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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