Total Knee Arthroplasty Functional Outcomes Study Research Design

Terminated

• Conditions: Osteoarthritis of the Knee
• Interventions: Device: Total knee arthroplasty patients

• Registration Number: NCT02228538
• Lead Sponsor: Restor3D

Brief Summary

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.

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-08-27
• Study First Posted: 2014-08-29
• Primary Completion: 2015-05
• Study Completion: 2016-09
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total knee arthroplasty patients	Total knee arthroplasty patients	ConforMIS iTotal (CR) knee implant system and off-the-shelf knee implant systems from various manufacturers

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States