This trial has been completed.

Condition knee osteoarthritis
Treatments zimmer, stryker
Sponsor Duke University
Start date February 2013
End date February 2016
Trial size 60 participants
Trial identifier NCT01811563, 193447, Pro00043737


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
(Active Comparator)
Subjects will be receiving the Stryker Triathlon total knee replacement
(Active Comparator)
Subjects will be receiving a Zimmer NexGen total knee replacement

Primary Outcomes

Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance)
time frame: baseline, 6 and 52 weeks post total knee replacement

Secondary Outcomes

Change in Walking Speed
time frame: baseline, 6 and 52 weeks after total knee replacement

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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.

Additional Information

Official title Clinical and Functional Outcomes Following Total Knee Replacement Using Two Different Implants
Principal investigator Samuel S Wellman, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Duke University.