Two Year Study With Robotic-Arm Assisted Hip Surgery.

Study Overview
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Brief Summary
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This study will involve a quantitative assessment of prospectively collected computed tomography, radiographic and patient outcomes data from multiple centers. Specifically looking at acetabular cup placement during Total Hip Arthroplasty by either traditional or robotic-arm assisted placement.

Detailed Description
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The incidence of dislocation following total hip arthroplasty (THA) has been reported to be from 1% to as much as 3.2%. The demand for THA is expected to increase. Post- dislocation solutions include closed reduction, open reduction, THA revision, and constrained cup, conversion to hemiarthroplasty, allograft or girdlestone resection. These solutions are often costly, painful and can involve substantial additional risks and complications. Acetabular cup placement is an important factor in the stability of the THA. Cup malpositioning has been associated with bearing surface ware and dislocation. For most patients, acceptable angles for abduction are 40° abduction (±10°) and 20° (±5°) version. However, malpositioning continues to occur resulting in cup angles outside acceptable ranges and leaving patients with an increased risk of dislocation. This objective of this study is to examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.

Official Title
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A Two Year Multicenter Study of Robotic-Arm Assisted THA: Acetabular Cup Placement Accuracy and Clinical Outcomes

Conditions
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Surgery, Hip Osteoarthritis

Intervention / Treatment
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* Procedure: Robotic-Arm Assisted THA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring primary total hip arthroplasty Patients willing and able to comply with follow-up requirements Patients willing to sign an Institutional Review Board approved informed consent form. Exclusion Criteria: Patients with Body Mass Index >45 Patients who are <18 years of age Patients with an active infection or suspected latent infection in or about the hip joint Bone stock that is inadequate for support or fixation of the prosthesis Previous major hip surgery excluding hip arthroscopy Total hip arthroplasty using cement fixation or resurfacing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Traditional THA. | |
| Active Comparator: Intervention<br>Robotic-arm assisted THA. | Procedure: Robotic-Arm Assisted THA<br>* The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of acetabular cup placement manually vs. robotic-arm assisted when controlled for approach (DA vs Posterior). | Accuracy of cup placement will be measured by being within 5 degrees of the target version (40 degrees) and abduction (20 degrees). Using CT (Computed Tomography) Scans, HAS (Martell Hip Analysis Suite) analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone. | 3/6 months | 
| Change in patient reported Hip dysfunction and Osteoarthritis Outcome Score (HOOS) survey over 2 year period. | The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process . To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. To calculate the total HOOS score the subscales need to be summed up. | Preop, 3/6 months, 1year, 2 year | 
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) survey over a 2 year period. | The PROMIS Global-10 short form consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. Higher scores indicate a healthier patient. | Preop, 3/6 months, 1year, 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical trial, randomization, hip arthroplasty