Clinical trial NCT02228538: Total Knee Arthroplasty Functional Outcomes Study Research Design
Official title: Total Knee Arthroplasty Functional Outcomes Study Research Design
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis of the Knee
Keywords: total knee arthroplasty
osteoarthritis
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
Collaborators: name: Ochsner Health System
First posted: 2014-08-29
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total knee arthroplasty patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Timed Functional Tests at 6 weeks
timeFrame: 6 weeks post-op
measure: Timed Functional testing at 6 months
timeFrame: 6 months post op
measure: Timed Functional Testing at 1 year
timeFrame: 1 year post-op
Secondary outcomes:
measure: Outcome questionnaires at 6 weeks
timeFrame: 6 weeks post-op
measure: Outcome questionnaires at 6 months
timeFrame: 6 months post-op
measure: Outcome questionnaires at 1 year
timeFrame: 1 year post op
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
Study officials:
affiliation: Ochsner Heath System
name: Deryk Jones, MD
role: PRINCIPAL_INVESTIGATOR
References: