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Completed

NCT Number: NCT01176292

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotating Platform High-Flex Cruciate Substituting TKA

Device

Rotating Platform Cruciate Substituting TKA

Device

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Anderson Orthopaedic Research Institute

Other

Collaborators

  • DePuy Orthopaedics

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Aug 6, 2010
Registry last updated
Nov 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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