Total Knee Arthroplasty: Functional and Clinical Outcomes

NCT01811563 | Completed Results DMC

• 2 other identifiers: Pro00043737193447
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Total Knee Replacement; Lower Quarter Y-Balance Test; Functional Outcomes; Patient Reported Outcomes

Outcome Measures

Primary Outcomes (2)

• Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement

  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. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.

  Baseline (Pre-Operative) to 6 weeks following total knee replacement

• Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement

  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. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.

  Baseline (Pre-Operative) to 52 weeks following total knee replacement

Secondary Outcomes (2)

• Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement.

  Baseline and 52 weeks following total knee replacement

• Walking Speed at 6 Weeks Following Total Knee Replacement.

  6 weeks following total knee replacement

Other Outcomes (7)

• Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement.

  Baseline and 52 weeks following total knee replacement

• University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement.

  6 weeks following total knee replacement

• Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement.

  Baseline (Pre-Operative) and 52 weeks following total knee replacement

Study Arms (2)

Stryker

ACTIVE COMPARATOR

Subjects will be receiving the Stryker Triathlon total knee replacement

Device: Stryker

Zimmer

ACTIVE COMPARATOR

Subjects will be receiving a Zimmer NexGen total knee replacement

Device: Zimmer

Interventions

Zimmer DEVICE

Zimmer

Stryker DEVICE

Stryker

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring primary total knee replacement
• Patients willing and able to comply with the follow-up visits and evaluations
• Patients willing to sign informed consent approved by the Institutional Review Board

You may not qualify if:

• Patients with inflammatory arthritis
• Patients with diabetic neuropathy
• Patients unable to ambulate without the use of an assistive device prior to surgery
• Patients unable to stand in single limb stance on each foot prior to surgery.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Samuel Wellman, MD
• Organization: Duke University Medical Center

samuel.wellman@duke.edu

919-681-4055

Study Officials

• Samuel S Wellman, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 14, 2013
• Study Start: February 1, 2013
• Primary Completion: February 26, 2016
• Study Completion: February 26, 2016
• Last Updated: June 2, 2017
• Results First Posted: June 2, 2017

Record last verified: 2017-04

Locations

US (1)