Prospective Functional Outcome Study of the Knee (PFOSK)

August 27, 2019 updated by: Tufts Medical Center
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 .

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Total knee arthroplasty patients

Description

Inclusion Criteria:

  • Patient is a 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 younger than 18 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Total Knee Arthroplasty patients
TKA patients
Device: Total Knee Arthroplasty
Knee replacement
Other Names:
  • ConforMIS, Off the shelf, TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional testing
Time Frame: 6 weeks post-op
Assess patient functional outcomes
6 weeks post-op
Functional testing
Time Frame: 6 months post-op
Assess patient functional outcomes
6 months post-op
Functional testing
Time Frame: 1-year post-op
Assess patient functional outcomes
1-year post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome questionnaires
Time Frame: 6-weeks post-op
to assess knee pain and function
6-weeks post-op
Outcome questionnaires
Time Frame: 6-months post-op
to assess knee pain and function
6-months post-op
outcome questionnaires
Time Frame: 1-year post-op
to assess knee pain and function
1-year post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Collaborators

ConforMIS, Inc.

Investigators

  • Principal Investigator: Eric L Smith, MD, Tufts Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

March 3, 2014

First Posted (Estimate)

March 5, 2014

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11109-Conformis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Due to PI moving locations and site closing out study, not all follow-up data will be collected and results will not be analyzed

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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