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Prospective Functional Outcome Study of the Knee (PFOSK)

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ClinicalTrials.gov Identifier: NCT02079493
Recruitment Status : Unknown
Verified April 2014 by Tufts Medical Center.
Recruitment status was:  Recruiting
First Posted : March 5, 2014
Last Update Posted : April 3, 2014
Sponsor:
Collaborator:
ConforMIS, Inc.
Information provided by (Responsible Party):
Tufts Medical Center

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: ConforMIS iTotal (CR) knee implant system and any off-the-shelf standard knee implant system from various manufacturers.

Detailed Description:
This study aims to use up to 75 patients at 3 centers to determine a baseline short-term postoperative 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.

Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Functional Outcome Study of the Knee
Study Start Date : January 2014
Estimated Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Total Knee Arthroplasty patients Device: ConforMIS iTotal (CR) knee implant system and any off-the-shelf standard knee implant system from various manufacturers.



Primary Outcome Measures :
  1. Functional testing [ Time Frame: 6 weeks post-op ]
    asess patient functional outcomes

  2. Functional testing [ Time Frame: 6 months post-op ]
    asess patient functional outcomes

  3. Functional testing [ Time Frame: 1-year post-op ]
    asess patient functional outcomes


Secondary Outcome Measures :
  1. Outcome questionnaires [ Time Frame: 6-weeks post-op ]
    to assess knee pain and function

  2. Outcome questionnaires [ Time Frame: 6-months post-op ]
    to assess knee pain and function

  3. outcome questionnaires [ Time Frame: 1-year post-op ]
    to assess knee pain and function



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Total knee arthroplasty patients
Criteria

Inclusion Criteria:

  • Patient is a male or non-pregnant female age 55 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 younger than 55 years of age
  • Patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopaedic 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
  • Patient is diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. Lupus Erythematosus, Paget's Disease)
  • Patient is immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days)
  • Patient has 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): NCT02079493


Contacts
Contact: Mary E Pevear, BA 617-636-7846 orthopaedicresearch@tuftsmedicalcenter.org

Locations
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Mary E Pevear, BA         
Sponsors and Collaborators
Tufts Medical Center
ConforMIS, Inc.
Investigators
Principal Investigator: Eric L Smith, MD Tufts Medical Center

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT02079493     History of Changes
Other Study ID Numbers: 11109-Conformis
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014

Keywords provided by Tufts Medical Center:
osteoarthritis
knee replacement
functional testing

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