NCT02830997

Total Knee Arthroplasty Guidance Systems Study

A Comparison of Surgical Technologies for Accuracy of Prosthesis Placement and Ease of Surgeon Use in Total Knee Arthroplasty

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Ormonde M. Mahoney, MD · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

In total knee replacement operations, the surgeon uses techniques and instruments to guide the operation and ensure that all parts of the prosthesis (the artificial knee surfaces) are placed into the correct position. There are many techniques a surgeon can use to achieve accuracy in the operation. This study will compare the Principal Investigator's present precision-guided technique and instrumentation methods with a newly developed technique that uses a computer-based stereotactic guidance system. The purposes of the study are: 1.) to learn whether the use of the different guidance systems results in differences of accuracy of the placement of the prosthesis; 2.) to compare the length of time it takes an experienced joint replacement specialist to complete the operation using the different guidance systems; 3.) to learn whether there are advantages of either system in terms of the function and recovery of patients over the first year after surgery; and, 4.) to provide the manufacturer of the stereotactic guidance system with feedback on the technical ease of use and workflow ease of the system which may be used for training and education purposes and/or for planning further refinements to the system. The study will enroll up to 150 patients from Athens Orthopedic Clinic over 2 to 3 years.

Detailed description

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: 1. Demographic and background information (age, sex, height, weight, social (occupation/employment), major comorbidity (broadly classified), smoking) 2. Patient reported outcome measures (Veteran's Rand 12-item Health Survey; 2011 Knee Society Score) 3. Physical Examination (knee range of motion, knee stability) 4. Details of the surgical operation 5. Operating room workflow details, including skin-to-skin surgical time 6. Post-operative disposition 7. Radiologic outcomes 1. Routine pre- and post-operative radiographs will be reviewed for limb alignment and evidence of prosthesis fixation 2. 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'. 8. Adverse events 9. 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.

Conditions

• Osteoarthritis, Knee
• Arthroplasty, Replacement, Knee

Interventions

Type	Name	Description
DEVICE	Stereotactic guidance system

Timeline

• Start date: 2016-07-12
• Primary completion: 2018-02-06
• Completion: 2021-01-05
• First posted: 2016-07-13
• Last updated: 2022-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study