Clinical trial NCT03052790: Comparison of Implant Positioning With Robotic Aided Surgery and Traditional Jig Positioning in Total Knee Arthroplasty
Official title: Comparison of Implant Positioning With Robotic Aided Surgery and Traditional Jig Positioning in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Arthritis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the outcomes and accuracy of implant positioning in robotic assisted total knee arthroplasty with traditional manually instrumented total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Patients who have knee pain and are candidates for total knee arthroplasty
* Patients able to consent to be included in the study

Exclusion Criteria:

* Patients with previous total or partial knee arthroplasty in need of revision surgery
* Patients unable to or unwilling to undergo post-operative CT scans after understanding the risks and benefits

Primary outcomes:
measure: Summation of angle differences between pre-operative plan and the final implant position as indicated by computed tomography (CT)
timeFrame: within 2 weeks before surgery, within one month of surgery
Secondary outcomes:
measure: Pain as assessed by the PROMIS 10 measurement system
timeFrame: within 2 weeks before surgery
measure: Pain as assessed by the PROMIS 10 measurement system
timeFrame: 3 months after surgery
measure: Pain as assessed by the PROMIS 10 measurement system
timeFrame: 6 months after surgery
measure: Pain as assessed by the PROMIS 10 measurement system
timeFrame: 1 year after surgery
measure: Function as assessed by the PROMIS 10 measurement system
timeFrame: within 2 weeks before surgery
measure: Function as assessed by the PROMIS 10 measurement system
timeFrame: 3 months after surgery
measure: Function as assessed by the PROMIS 10 measurement system
timeFrame: 6 months after surgery
measure: Function as assessed by the PROMIS 10 measurement system
timeFrame: 1 year after surgery
measure: Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
timeFrame: within 2 weeks before surgery
measure: Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
timeFrame: 3 months after surgery
measure: Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
timeFrame: 6 months after surgery
measure: Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
timeFrame: 1 year after surgery
measure: Pain as assessed by a Visual Analogue Scale (VAS)
timeFrame: within 2 weeks before surgery
measure: Pain as assessed by a Visual Analogue Scale (VAS)
timeFrame: 3 months after surgery
measure: Pain as assessed by a Visual Analogue Scale (VAS)
timeFrame: 6 months after surgery
measure: Pain as assessed by a Visual Analogue Scale (VAS)
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Adam Freedhand, MD
role: PRINCIPAL_INVESTIGATOR
References: