Prospective Functional Outcome Study of the Knee

Terminated

• Conditions: Osteoarthritis of the Knee
• Interventions: Device: Total Knee Arthroplasty

• Registration Number: NCT02079493
• Lead Sponsor: 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 .

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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-03-03
• Study First Posted: 2014-03-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total Knee Arthroplasty patients	Total Knee Arthroplasty	TKA patients

Primary Outcome Measures

Name	Time	Method
Functional testing	1-year post-op	Assess patient functional outcomes

Secondary Outcome Measures

Name	Time	Method
Outcome questionnaires	6-months post-op	to assess knee pain and function
outcome questionnaires	1-year post-op	to assess knee pain and function

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States