Total Knee Arthroplasty Functional Outcomes Study Research Design

Osteoarthritis of the Knee Clinical Trial

Official title:

Total Knee Arthroplasty Functional Outcomes Study Research Design

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02228538
• Other study ID #: 13-003
• Status: Terminated
• Start date: October 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2023
• Source: Restor3D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: September 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• Total knee arthroplasty patients
ConforMIS iTotal (CR) knee implant system & off-the-shelf standard knee implant system from various manufacturers

Locations

Country	Name	City	State
United States	Ochsner Clinic Foundation	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Restor3D	Ochsner Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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 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
Secondary	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
Secondary	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