Clinical trial NCT02079493: Prospective Functional Outcome Study of the Knee
Official title: Prospective Functional Outcome Study of the Knee
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis
knee replacement
functional testing
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Restor3D
First posted: 2014-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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 postoperative 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 a 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 younger than 18 years of age
* Patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopaedic 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
* Patient is diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. Lupus Erythematosus, Paget's Disease)
* Patient is immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days)
* Patient has a known sensitivity to device materials
* Non-English speaking patients
* Patient is a prisoner

Primary outcomes:
measure: Functional testing
timeFrame: 6 weeks post-op
measure: Functional testing
timeFrame: 6 months post-op
measure: Functional testing
timeFrame: 1-year post-op
Secondary outcomes:
measure: Outcome questionnaires
timeFrame: 6-weeks post-op
measure: Outcome questionnaires
timeFrame: 6-months post-op
measure: outcome questionnaires
timeFrame: 1-year post-op
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Eric L Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: