Total Knee Arthroplasty: Functional and Clinical Outcomes

NCT ID: NCT01811563

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-02-26

Brief 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.

Detailed Description

The number differences in subjects analyzed from baseline to 6 weeks to 52 weeks are due to the fact that we did not use the 6 week time point in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making. Therefore the patients used in the final analysis were those subjects who were able to and completed the assessment at pre-op and 1 year post-op which is how we get to the 20 subjects per group.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Stryker

Subjects will be receiving the Stryker Triathlon total knee replacement

Group Type: ACTIVE_COMPARATOR

Stryker

Intervention Type: DEVICE

Zimmer

Subjects will be receiving a Zimmer NexGen total knee replacement

Group Type: ACTIVE_COMPARATOR

Zimmer

Intervention Type: DEVICE

Interventions

Zimmer

Intervention Type: DEVICE

Stryker

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel S Wellman, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

193447

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00043737

Identifier Type: -

Identifier Source: org_study_id