Mini Stem Radiostereometric Analysis Study

Study Overview
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Brief Summary
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The objectives of this study are to assess migration of the MIS Stem compared to the Synergy Hip System using Radiostereometric Analysis (RSA), and to assess the long-term safety and effectiveness of the study device. This study will document any device-related surgical or post-operative complications and adverse radiographic observations. Subjects meeting the entrance criteria specified in this protocol will be randomized as they become available.

Detailed Description
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The purpose of the current investigation is to compare migration of the device after implantation with a modular, short hip stem called the MIS Stem or a standard THA using the Synergy Hip System using RSA. The intended use of this product is for patients with inflammatory and non-inflammatory degenerative joint disease who require a primary total hip replacement.

Official Title
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A Randomized Controlled Trial to Compare Implant Migration of the MIS Stem Versus The Synergy Total Hip System by Radiostereometric Analysis

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Device: MIS Femoral Neck Stem implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has hip disease that requires a total hip arthroplasty. Subject is willing to consent to participation in the study. Subject plans to be available for follow-up through study duration. Subject is of stable health and is free of or treated and stabilized for any condition that would prose excessive operating risk. Exclusion Criteria: Subject has insufficient femoral bone stock. Subject has had major non-arthroscopic surgery to the study hip. Subject has physical, emotional or neurological conditions that would compromise the subjects compliance with postoperative rehabilitation and follow-up. Subject has a known sensitivity to materials in the device.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MIS Femoral Neck Stem<br>Subject will be randomized to either MIS or Synergy implant. | Device: MIS Femoral Neck Stem implant<br> <br> |
| Synergy Hip System<br>Subject will be randomized to either Synergy or MIS implant. | Device: MIS Femoral Neck Stem implant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement) | Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System. | Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported | 
| Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement) | Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System. | Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | Preoperative | 
| 3 Months Postoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | 3 months postoperative | 
| 1 Year Postoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | 1 year postoperative | 
| 2 Years Postoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | 2 years postoperative | 
| 3 Years Postoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | 3 years postoperative | 
| 5 Years Postoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | 5 years postoperative | 
| Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | Preoperative | 
| 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | 3 months postoperative | 
| 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | 1 year postoperative | 
| 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | 2 years postoperative | 
| 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | 3 years postoperative | 
| 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | 5 years postoperative | 
| Preoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | Preoperative | 
| 3 Months Postoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | 3 months postoperative | 
| 1 Year Postoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | 1 year postoperative | 
| 2 Years Postoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | 2 years postoperative | 
| 3 Years Postoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | 3 years postoperative | 
| 5 Years Postoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | 5 years postoperative |