Total Knee Arthroplasty Functional Outcomes Study Research Design

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Device: Total knee arthroplasty patients

Detailed Description

This study aims to use up to 75 patients at 3 centers to determine a baseline short-term post-operative 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 Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Total knee arthroplasty patients

Description

Inclusion Criteria:

• Patient is 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 with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopedic 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
• Patients diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. Lupus Erythematosus, Paget's disease)
• Patients immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days)
• Patients with a known sensitivity to device materials
• Non-English speaking patients
• Patient is a prisoner

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Total knee arthroplasty patients; ConforMIS iTotal (CR) knee implant system and off-the-shelf knee implant systems from various manufacturers	Device: Total knee arthroplasty patients; ConforMIS iTotal (CR) knee implant system & off-the-shelf standard knee implant system from various manufacturers; Other Names: knee replacement; joint replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Functional Tests at 6 weeks	Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.	6 weeks post-op
Timed Functional testing at 6 months	Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.	6 months post op
Timed Functional Testing at 1 year	Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.	1 year post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcome questionnaires at 6 weeks	Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients.	6 weeks post-op
Outcome questionnaires at 6 months	Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients.	6 months post-op
Outcome questionnaires at 1 year	Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients.	1 year post op

Collaborators and Investigators

• Sponsor: Restor3D
• Collaborators: Ochsner Health System
• Investigators: Principal Investigator: Deryk Jones, MD, Ochsner Heath System

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: June 5, 2014
• First Submitted That Met QC Criteria: August 27, 2014
• First Posted (Estimated): August 29, 2014

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: osteoarthritis; total knee arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 13-003