Total Knee Arthroplasty: Functional and Clinical Outcomes

Knee Osteoarthritis Clinical Trial

Official title:

Clinical and Functional Outcomes Following Total Knee Replacement Using Two Different Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811563
• Other study ID #: Pro00043737
• Secondary ID: 193447
• Status: Completed
• Phase: N/A
• First received: March 12, 2013
• Last updated: December 19, 2016
• Start date: February 2013
• Est. completion date: February 2016

Study information

• Verified date: July 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the differences in functional and patient reported outcomes between total knee replacement (TKA) implants. In addition, this work will examine the correlation between functional assessments and patient reported outcomes following surgery. All subjects will complete assessments preoperatively, 4-6 weeks following TKA and then one year following TKA. Subjects will complete a series of patient reported outcomes as well as a series of functional outcomes at each of the time points of interest. The analysis will include a repeated measures design to determine differences between groups across time as well as correlations between the functional and patient reported outcomes. This work will hopefully determine the importance of using objective functional outcomes following TKA as well as determining the need for patient assessments out to one year following surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Patients requiring primary total knee replacement

2. Patients willing and able to comply with the follow-up visits and evaluations

3. Patients willing to sign informed consent approved by the Institutional Review Board

Exclusion Criteria:

1. Patients with inflammatory arthritis

2. Patients with diabetic neuropathy

3. Patients unable to ambulate without the use of an assistive device prior to surgery

4. Patients unable to stand in single limb stance on each foot prior to surgery.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Zimmer

• Stryker

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in University of California, Los Angeles (UCLA) activity score	The UCLA activity score is a validated patient reported outcome of overall physical activity	baseline, 6 and 52 weeks after total knee replacement	No
Other	Change in Knee injury and Osteoarthritis Outcome Score (KOOS)	The KOOS is a standardized and validated patient outcome score that assesses functional limitation in patient with knee problems.	baseline, 6 and 52 weeks following total knee replacement	No
Other	Change in Forgotten Joint Score (FJS)	The FJS is a patient reported measure of how bothersome the total joint replacement is for them, how much it affects daily activity and how much they are aware of the implant.	baseline, 6 and 52 weeks following total knee replacement	No
Other	Change in Knee Society Score (KSS)	The KSS is a patient reported measure of knee function that is specific to patients who are scheduled to receive or have previously had a total knee replacement. This outcome measures both patient reported pain and function changes from prior to surgery through recovery.	baseline, 6 and 52 weeks following total knee replacement	No
Other	Change in Sit to Stand Time	The sit to stand test requires patients to stand up and sit down as many times as possible in 10 seconds from a standard arm chair.	baseline, 6 and 52 weeks following total knee replacement	No
Other	Change in Timed get up and go	The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.	baseline, 6 and 52 weeks following total knee replacement	No
Primary	Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance)	The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform.	baseline, 6 and 52 weeks post total knee replacement	Yes
Secondary	Change in Walking Speed	Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.	baseline, 6 and 52 weeks after total knee replacement	No