Robotic Instrumentation in THA

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multi-center, two-arm, randomized, controlled post-market study to evaluate and compare the clinical accuracy of component placement in robotic-assisted THA and that of traditional methods.

Detailed Description
-----------------
Sites will enroll participants into two separate arms for this study (rTHA and Conventional Instrumentation), following the assigned randomization. Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for participation in the study, and will be pre-screened for participation in the informed consent process. The primary objective of this study is to evaluate and compare the accuracy of the Robotic Total Hip System in regards to implant placement with that of traditional instrumentation. Secondary Objectives include the evaluation of safety and efficacy of this system and will include the assessment of common adverse events, physical exam findings, radiologic results and patient reported outcome measures. Data collection will occur at the following intervals: Pre-operative, Operative, 6-weeks, 3-months, 1-year, and 2-years. Enrollment for the study is anticipated to last approximately 12 months. Allowing for 24 months of follow-up, the total estimated study time to final-patient final-visit will be approximately 36-42 months.

Official Title
-----------------
A Post-Market, Multi-Center, Randomized Controlled Trial on Robotic Instrumentation in Patients Undergoing Total Hip Arthroplasty

Conditions
-----------------
Osteoarthritis, Hip

Intervention / Treatment
-----------------
* Device: One of the following hip implants may be used within this arm of the study: G7 Acetabular System, Taperloc Complete System, Avenir and Avenir Complete Systems, and Echo Bi-Metric System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 - 80 years Body mass index ≤40 kg/m2 Patient is willing and able to provide informed consent. Patient qualifies for primary THA, via an anterior approach, due to osteoarthritis of the hip based on investigator's clinical judgment Independent of study participation, patient is a candidate and meets the indications and none of the contraindications for use with the ROSA Hip System Exclusion Criteria: Has undergone an orthopaedic procedure, of the spine or lower extremity, or is currently participating in a pain management study of any joint within the last 6 months or planned within the next 6 months Infection, sepsis, osteomyelitis, avascular necrosis of the hip joint Patient is at a high risk for dislocation including those with long-segment spinal fusions (>3 levels) and neuromuscular disorders. Inflammatory or Post-traumatic arthropathy, or any other degenerative joint disease not consistent with osteoarthritis. Would, in the investigator's opinion, be unwilling or unable to comply with the postoperative follow-up schedule Patient is considered a member of a vulnerable population (Pregnant, prisoner, mentally incompetent, etc.) Previous hardware in the proximal femur or acetabulum from a prior orthopaedic procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robotic-Assisted THA<br>Randomized participants will receive THA via the ROSA Hip System. | Device: One of the following hip implants may be used within this arm of the study: G7 Acetabular System, Taperloc Complete System, Avenir and Avenir Complete Systems, and Echo Bi-Metric System<br>* Total Hip Arthroplasty<br>|
| Active Comparator: Traditional/Conventional THA<br>Randomized participants will receive the THA via Conventional/Traditional THA Methods. | Device: One of the following hip implants may be used within this arm of the study: G7 Acetabular System, Taperloc Complete System, Avenir and Avenir Complete Systems, and Echo Bi-Metric System<br>* Total Hip Arthroplasty<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of implant position | To compare and evaluate the accuracy of implant position of robotic-arm surgical assistant (ROSA® Total Hip System) with that of conventional instrumentation (Traditional THA). Accuracy of the implant will be evaluated by assessing radiographic alignment post-operatively for participants enrolled for both Conventional Instrumentation and the ROSA® Hip System. Accuracy of acetabular implant position will be assessed by evaluating the percentage of participants who are within the range of the Callanan safe zones for Acetabular Inclination (30 - 45 degrees). A patient is considered a success if their 4-week CT scan shows the postoperative acetabular inclination to be within this safe zone range. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Patient safety | Frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies. | 24 months | 
| Patient Reported Outcome Measure (Oxford Hip Score) | A questionnaire completed by the patient consisting of twelve questions that utilize a 5-point Likert scoring system (0 - 4) resulting in a score ranging from 0 (worst) to 48 (best). | 24 months | 
| Patient Reported Outcome Measure (HOOS-Jr) | A questionnaire completed by the patient consisting of 6 items from the original HOOS survey. Items are coded from 0 to 4, none to extreme respectively | 24 months | 
| Numeric Pain Rating Scale (NPRS) | An 11-point NPRS is a patient self-completed reported outcome and will be used to assess the current level of pain for the affected hip. On this scale, 0 will indicate no pain and 10 will indicate the worst pain imaginable | 24 months | 
| Subject Satisfaction | A questionnaire consisting of a single satisfaction question in regard to the subjects hip replacement. Answers will include the following: Very Dissatisfied, Dissatisfied, Neutral, Satisfied, Very Satisfied. | 24 months | 
| Clinical performance will be assessed with evaluation of range of motion. | Range of motion will be evaluated in a supine position and assess flexion, abduction (in flexion), adduction (in flexion), external rotation (in extension), and internal rotation (in extension). Range of motion will be measured in degrees. | 24 months | 
| Clinical performance will be assessed with evaluation of stability using the Trendelenburg test. | The test is negative when the hip of the leg that is lifted, will also go up i.e., hiking of hip or the pelvis tilts upwards. The test is positive, when there is a drop of the hip or a downwards tilt of the pelvis. The test is level when the subject presents normal gait and adequate pelvic stability. If the subject is unable to perform the test, this will be noted unable to perform test. | 24 months | 
| Clinical performance will be assessed by testing leg length discrepancy. | This will be assessed by (3) categories (legs equal, right short, left short) and discrepancies will be measured in mm or cm. | 24 months |