Prospective Functional Outcome Study of the Knee

Osteoarthritis of the Knee Clinical Trial

— PFOSK  

Official title:

Prospective Functional Outcome Study of the Knee

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02079493
• Other study ID #: 11109-Conformis
• Status: Terminated
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: August 2019
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• Total Knee Arthroplasty
Knee replacement

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	ConforMIS, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional testing	Assess patient functional outcomes	6 weeks post-op
Primary	Functional testing	Assess patient functional outcomes	6 months post-op
Primary	Functional testing	Assess patient functional outcomes	1-year post-op
Secondary	Outcome questionnaires	to assess knee pain and function	6-weeks post-op
Secondary	Outcome questionnaires	to assess knee pain and function	6-months post-op
Secondary	outcome questionnaires	to assess knee pain and function	1-year post-op