Total Knee Arthroplasty Guidance Systems Study
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|ClinicalTrials.gov Identifier: NCT02830997|
Recruitment Status : Enrolling by invitation
First Posted : July 13, 2016
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment|
|Osteoarthritis, Knee Arthroplasty, Replacement, Knee||Device: Stereotactic guidance system|
The open-label study aims to enroll up to 75 participants into the conventional guidance arm followed by 75 participants into the stereotactic guidance arm, in sequence.
Detailed observational data will be collected during the surgical procedures, and participating patients will be evaluated at prescribed intervals (pre-operatively, and 2,4,6, and 12 months post-operatively) using survey instruments, clinical indicators, and routine radiologic outcomes. Radiologic outcomes will be assessed using standard x-rays that are obtained in the course of normal care for all patients who undergo total knee arthroplasty (TKA). A subset of the first 30 patients enrolled into each treatment arm will, in addition, be asked to voluntarily undergo a computed tomography (CT) scan of the lower extremity (hip, knee, and ankle joints) 8-12 weeks after surgery to measure 3-dimensional accuracy of prosthesis placement and limb alignment.
Data collection will include:
- Demographic and background information (age, sex, height, weight, social (occupation/employment), major comorbidity (broadly classified), smoking)
- Patient reported outcome measures (Veteran's Rand 12-item Health Survey; 2011 Knee Society Score)
- Physical Examination (knee range of motion, knee stability)
- Details of the surgical operation
- Operating room workflow details, including skin-to-skin surgical time
- Post-operative disposition
- Routine pre- and post-operative radiographs will be reviewed for limb alignment and evidence of prosthesis fixation
- Post-operative CT scans (hip, knee, ankle) will be used to evaluate accuracy of placement of the TKA prosthesis (femoral and tibial components) and accuracy of limb alignment in the coronal, sagittal, and axial planes. The values measured from the post-operative CT scan will be compared to those of the final intra-operative plan; lack of difference between the two will constitute 'accuracy'.
- Adverse events
- Patients may optionally participate in an additional clinical follow-up visit at 2 years post-operatively, which will include the patient reported outcome measures, physical, examination, and radiographic examination.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||A Comparison of Surgical Technologies for Accuracy of Prosthesis Placement and Ease of Surgeon Use in Total Knee Arthroplasty|
|Actual Study Start Date :||July 12, 2016|
|Actual Primary Completion Date :||February 6, 2018|
|Estimated Study Completion Date :||June 1, 2021|
The conventional guidance will undergo TKA surgery with use of the Investigator's usual precision guided technique based on conventional instrumentation (mechanical and simple computer-assisted guidance techniques). For participants of the conventional guidance arm, the Investigator will employ the established technique he currently employs for all routine TKA procedures and would employ if the patient were not a participant in the study.
The stereotactic guidance group will undergo their TKA surgery with use of a stereotactic guidance system.
Device: Stereotactic guidance system
Other Name: Stryker robotic arm system (Mako)
- Accuracy of total knee arthroplasty component placement in the coronal, axial, and sagittal planes measured by computed tomography scan [ Time Frame: 2 months post-operatively ]Difference of coronal alignment between pre-operative plan and resultant alignment measured by post-operative CT scan
- Skin-to-skin surgical time in minutes [ Time Frame: measured during the surgical operation ]Skin-to-skin surgical time in minutes
- Patient reported physical function measured by 2011 Knee Society Scoring System [ Time Frame: 2, 4, 6, and 12 months post-operatively ]Patient reported physical function measured by 2011 Knee Society Scoring System
- Patient reported health related quality of life measured by the Veteran's Rand 12-item Health Survey [ Time Frame: 2, 4, 6, and 12 months post-operatively ]Patient reported health related quality of life measured by the Veteran's Rand 12-item Health Survey
- Patient reported satisfaction measured by 2011 Knee Society Scoring System [ Time Frame: 2,4,6, and 12 months post-operatively ]Patient reported satisfaction measured by 2011 Knee Society Scoring System
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830997
|United States, Georgia|
|Athens Orthopedic Clinic, P.A.|
|Athens, Georgia, United States, 30606|
|Principal Investigator:||Ormonde M Mahoney, MD||Athens Orthopedic Clinic, P.A.|
|Study Director:||Tracy L Kinsey, MSPH||Athens Orthopedic Clinic, P.A.|