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Total Knee Arthroplasty Functional Outcomes Study Research Design

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02228538
Recruitment Status : Terminated (Not enough subject participation)
First Posted : August 29, 2014
Last Update Posted : September 21, 2016
Sponsor:
Collaborator:
Ochsner Health System
Information provided by (Responsible Party):
ConforMIS, Inc.

Brief Summary:
The purpose of this study is to obtain patient oriented and clinically oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty.

Condition or disease Intervention/treatment
Osteoarthritis of the Knee Device: Total knee arthroplasty patients

Detailed Description:
This study aims to use up to 75 patients at 3 centers to determine a baseline short-term post-operative physical function status of patients undergoing a total knee arthroplasty through patient and clinically based assessments. The KOOS score will collect data on the patient's physical function, stiffness and pain. The BERG balance, TUG, and TUDS tests will be used quantitatively to assess the patient's ability to conduct activities of daily living like walking for an extended period of time, standing from a seated position, and maintaining balance while performing a series of actions.

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Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Total Knee Arthroplasty Functional Outcomes Study Research Design
Study Start Date : October 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Total knee arthroplasty patients
ConforMIS iTotal (CR) knee implant system and off-the-shelf knee implant systems from various manufacturers
Device: Total knee arthroplasty patients
ConforMIS iTotal (CR) knee implant system & off-the-shelf standard knee implant system from various manufacturers
Other Names:
  • knee replacement
  • joint replacement




Primary Outcome Measures :
  1. Timed Functional Tests at 6 weeks [ Time Frame: 6 weeks post-op ]
    Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.

  2. Timed Functional testing at 6 months [ Time Frame: 6 months post op ]
    Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.

  3. Timed Functional Testing at 1 year [ Time Frame: 1 year post-op ]
    Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.


Secondary Outcome Measures :
  1. Outcome questionnaires at 6 weeks [ Time Frame: 6 weeks post-op ]
    Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients.

  2. Outcome questionnaires at 6 months [ Time Frame: 6 months post-op ]
    Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients.

  3. Outcome questionnaires at 1 year [ Time Frame: 1 year post op ]
    Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Total knee arthroplasty patients
Criteria

Inclusion Criteria:

  • Patient is male or non-pregnant female age 18 years or older at time of study
  • Patient is a candidate for a total knee arthroplasty
  • Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation

Exclusion Criteria:

  • Patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopedic surgeon
  • Patients who have had any previous lower extremity procedure
  • Patients with a BMI greater than or equal to 40
  • Patients with an active infection within the affected knee joint
  • Patients with a neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device
  • Patients diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. Lupus Erythematosus, Paget's disease)
  • Patients immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days)
  • Patients with a known sensitivity to device materials
  • Non-English speaking patients
  • Patient is a prisoner

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228538


Locations
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United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
ConforMIS, Inc.
Ochsner Health System
Investigators
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Principal Investigator: Deryk Jones, MD Ochsner Heath System

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Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT02228538    
Other Study ID Numbers: 13-003
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: May 2016
Keywords provided by ConforMIS, Inc.:
total knee arthroplasty
osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases