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

This study has been completed.
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by (Responsible Party):
William Hamilton, MD, Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier:
NCT01176292
First received: July 26, 2010
Last updated: July 30, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
Device: Rotating Platform High-Flex Cruciate Substituting TKA
Device: Rotating Platform Cruciate Substituting TKA

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Comparison of Rotating Platform Cruciate Substituting Total Knee Arthroplasty With Rotating Platform High-Flex Cruciate Substituting Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Anderson Orthopaedic Research Institute:

Primary Outcome Measures:
  • Clinical flexion [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
    Maximum, passive flexion and extension in the supine position will be measured and recorded using a long goniometer.

  • Clinical flexion [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
    Maximum, passive flexion and extension in the supine position will be measured and recorded using a long goniometer.

  • Clinical flexion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Maximum, passive flexion and extension in the supine position will be measured and recorded using a long goniometer.

  • Clinical flexion [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    Maximum, passive flexion and extension in the supine position will be measured and recorded using a long goniometer.


Secondary Outcome Measures:
  • Radiographic flexion [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.

  • Oxford Knee Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    A patient reported questionnaire for assessing the outcome of knee surgery.

  • Complications [ Time Frame: 4-6 week ] [ Designated as safety issue: Yes ]
    The number and type of adverse events will be monitored to assess safety.

  • Radiographic flexion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.

  • Oxford Knee Score [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    A patient reported questionnaire for assessing the outcome of knee surgery.

  • Complications [ Time Frame: 4-6 months ] [ Designated as safety issue: Yes ]
    The number and type of adverse events will be monitored to assess safety.

  • Complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The number and type of adverse events will be monitored to assess safety.

  • Complications [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
    The number and type of adverse events will be monitored to assess safety.


Enrollment: 142
Study Start Date: August 2007
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Rotating Platform High-Flex Cruciate Substituting TKA Device: Rotating Platform High-Flex Cruciate Substituting TKA
Rotating Platform Cruciate Substituting TKA Device: Rotating Platform Cruciate Substituting TKA

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176292

Sponsors and Collaborators
Anderson Orthopaedic Research Institute
DePuy Orthopaedics
Investigators
Principal Investigator: William G Hamilton, MD Anderson Orthopaedic Research Institute
  More Information

No publications provided

Responsible Party: William Hamilton, MD, Principal Investigator, Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier: NCT01176292     History of Changes
Other Study ID Numbers: AORI2010-0104
Study First Received: July 26, 2010
Last Updated: July 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Anderson Orthopaedic Research Institute:
total knee replacement
high flexion
range of motion
rotating platform
TKA

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 31, 2014