PINNACLE® DM RSA Study

Study Overview
=================
Brief Summary
-----------------
The primary objective is to establish the mean superior cup migration of the PINNACLE® Dual Mobility Construct using model-based RSA over the first two years post-implantation. The primary endpoint is the mean vertical subsidence (Y translation, also known as superior cup migration) at 2 years as measured with RSA. Additionally, the data from this study will be compared to historical PINNACLE® data obtained in study DSJ_2018_02.

Official Title
-----------------
Multi-Center, Non-Controlled, Prospective Radiostereometric Analysis of the PINNACLE® Dual Mobility Construct

Conditions
-----------------
Osteoarthritis, Degenerative Arthritis, Revision Arthroplasty

Intervention / Treatment
-----------------
* Device: Total Hip Arthroplasty
* Device: Revision Total Hip Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals requiring primary THA for: a severely painful and/or disabled joint (typically due to non-inflammatory degenerative joint disease). failed previous hip surgery. or dislocation risks. Individuals who are able to speak, read and comprehend the informed patient consent document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes. Individuals who are willing and able to return for follow-up as specified by the study protocol. Individuals who are a minimum age of 21 years at the time of consent. Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol. - Exclusion Criteria: Individuals have active local or systemic infection. Individuals who have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified. Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of bone fracture and/or the lack of adequate bone to support the implant(s). Individuals with Charcot's or Paget's disease. Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA. Women who are pregnant or lactating. Individuals who have had a contralateral hip that was implanted less than 6 months prior to the time of consent into this study or individuals that expect to have a contralateral hip implanted in the 6 months following the time of consent into this study. Individuals that have amputations in either leg that would impact rehabilitation following surgery. Individuals who are bedridden per the Investigators determination Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months. Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims. Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements. Individuals diagnosed and taking prescription medications to treat a muscular disorder that limits mobility due to sever stiffness and pain such as fibromyalgia or polymyalgia. Subject has a medical condition with less than 2 years life expectancy. Individual has a BMI >45 kg/m2. Individuals who require revision arthroplasty and have a well-fixed non-DePuy Synthes femoral stem or a well-fixed DePuy Synthes femoral stem that does not have a polished neck

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total Hip Arthroplasty<br>Pinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses | Device: Total Hip Arthroplasty<br>* Pinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses<br>* Other names: THA;|
| Experimental: Revision Total Hip Arthroplasty<br>Pinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses | Device: Revision Total Hip Arthroplasty<br>* Pinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses<br>* Other names: RTHA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean superior cup migration (subsidence) at 2 years | RSA measured mean superior cup migration (subsidence: Y translation in mm) at 2 years. This endpoint will be compared to historical Pinnacle data | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RSA measured cup subsidence at 3 months | RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell. This endpoint will be compared to historical Pinnacle data | 3 months | 
| X-axis translation of acetabular shell at 3 months | RSA measured X-axis translation of acetabular shell in mm. This endpoint will be compared to historical Pinnacle data | 3 months | 
| Z-axis translation of acetabular shell at 3 months | RSA measured Z-axis translation of acetabular shell in mm. This endpoint will be compared to historical Pinnacle data | 3 months | 
| X-axis rotation of the acetabular shell at 3 months | RSA measured X-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data | 3 months | 
| Y-axis rotation of the acetabular shell at 3 months | RSA measured Y-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data | 3 months | 
| Z-axis rotation of the acetabular shell at 3 months | RSA measured Z-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data | 3 months | 
| Maximal total point motion of the acetabular shell at 3 months | RSA measured maximal total point motion of the acetabular shell in mm. This endpoint will be compared to historical Pinnacle data | 3 months | 
| Harris Hip Score at 3 months | Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome. This endpoint will be compared to historical Pinnacle data | 3 months | 
| HOOS Jr. Score at 3 months | Functional and health status as measured with the HOOS Jr. score. This is a short version of the HOOS (hip disability and osteoarthritis outcome score) that has a result range of 0-100. A score of 0 indicates total hip disability and 100 indicates perfect hip health. This endpoint will be compared to historical Pinnacle data | 3 months | 
| FJS-12 at 3 months | Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result. This endpoint will be compared to historical Pinnacle data | 3 months | 
| RSA measured cup subsidence at 12 months | RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell. This endpoint will be compared to historical Pinnacle data | 12 months | 
| X-axis translation of acetabular shell at 12 months | RSA measured X-axis translation of acetabular shell in mm. This endpoint will be compared to historical Pinnacle data | 12 months | 
| Z-axis translation of acetabular shell at 12 months | RSA measured Z-axis translation of acetabular shell in mm. This endpoint will be compared to historical Pinnacle data | 12 months | 
| X-axis rotation of the acetabular shell at 12 months | RSA measured X-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data | 12 months | 
| Y-axis rotation of the acetabular shell at 12 months | RSA measured Y-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data | 12 months | 
| Z-axis rotation of the acetabular shell at 12 months | RSA measured Z-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data | 12 months | 
| Maximal total point motion of the acetabular shell at 12 months | RSA measured maximal total point motion of the acetabular shell in mm. This endpoint will be compared to historical Pinnacle data | 12 months | 
| Harris Hip Score at 12 months | Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome. This endpoint will be compared to historical Pinnacle data | 12 months | 
| HOOS Jr. Score at 12 months | Functional and health status as measured with the HOOS Jr. score. This is a short version of the HOOS (hip disability and osteoarthritis outcome score) that has a result range of 0-100. A score of 0 indicates total hip disability and 100 indicates perfect hip health. This endpoint will be compared to historical Pinnacle data | 12 months | 
| FJS-12 at 12 months | Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result. This endpoint will be compared to historical Pinnacle data | 12 months | 
| RSA measured cup subsidence at 6 months | RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell. This endpoint will be compared to historical Pinnacle data | 6 months | 
| X-axis translation of acetabular shell at 6 months | RSA measured X-axis translation of acetabular shell in mm. This endpoint will be compared to historical Pinnacle data | 6 months | 
| Z-axis translation of acetabular shell at 6 months | RSA measured Z-axis translation of acetabular shell in mm. This endpoint will be compared to historical Pinnacle data | 6 months | 
| X-axis rotation of the acetabular shell at 6 months | RSA measured X-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data | 6 months | 
| Y-axis rotation of the acetabular shell at 6 months | RSA measured Y-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data | 6 months | 
| Z-axis rotation of the acetabular shell at 6 months | RSA measured Z-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data | 6 months | 
| Maximal total point motion of the acetabular shell at 6 months | RSA measured maximal total point motion of the acetabular shell in mm. This endpoint will be compared to historical Pinnacle data | 6 months | 
| Harris Hip Score at 6 months | Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome. This endpoint will be compared to historical Pinnacle data | 6 months | 
| HOOS Jr. Score at 6 months | Functional and health status as measured with the HOOS Jr. score. This is a short version of the HOOS (hip disability and osteoarthritis outcome score) that has a result range of 0-100. A score of 0 indicates total hip disability and 100 indicates perfect hip health. This endpoint will be compared to historical Pinnacle data | 6 months | 
| FJS-12 at 6 months | Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result. This endpoint will be compared to historical Pinnacle data | 6 months | 
| RSA measured cup subsidence at 24 months | RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell. This endpoint will be compared to historical Pinnacle data | 24 months | 
| X-axis translation of acetabular shell at 24 months | RSA measured X-axis translation of acetabular shell in mm. This endpoint will be compared to historical Pinnacle data | 24 months | 
| Z-axis translation of acetabular shell at 24 months | RSA measured Z-axis translation of acetabular shell in mm. This endpoint will be compared to historical Pinnacle data | 24 months | 
| X-axis rotation of the acetabular shell at 24 months | RSA measured X-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data | 24 months | 
| Y-axis rotation of the acetabular shell at 24 months | RSA measured Y-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data | 24 months | 
| Z-axis rotation of the acetabular shell at 24 months | RSA measured Z-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data | 24 months | 
| Maximal total point motion of the acetabular shell at 24 months | RSA measured maximal total point motion of the acetabular shell in mm. This endpoint will be compared to historical Pinnacle data | 24 months | 
| Harris Hip Score at 24 months | Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome. This endpoint will be compared to historical Pinnacle data | 24 months | 
| HOOS Jr. Score at 24 months | Functional and health status as measured with the HOOS Jr. score. This is a short version of the HOOS (hip disability and osteoarthritis outcome score) that has a result range of 0-100. A score of 0 indicates total hip disability and 100 indicates perfect hip health. This endpoint will be compared to historical Pinnacle data | 24 months | 
| FJS-12 at 24 months | Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result. This endpoint will be compared to historical Pinnacle data | 24 months | 
| Cup Positioning at 6 weeks | Linear head penetration as determined by examining the change in distance between the center of the femoral head and the center of the acetabular shell at the 6-week exam. This endpoint will be compared to historical Pinnacle data | 6 weeks | 
| Cup Positioning at 12 months | Linear head penetration as determined by examining the change in distance between the center of the femoral head and the center of the acetabular shell between the 6-week exam and 12 months. This endpoint will be compared to historical Pinnacle data | 12 months | 
| Cup Positioning at 24 months | Linear head penetration as determined by examining the change in distance between the center of the femoral head and the center of the acetabular shell between the 6-week exam and 24 months. This endpoint will be compared to historical Pinnacle data | 24 months | 
| X-axis translation of acetabular shell at 6 weeks | RSA measured X-axis translation of acetabular shell in mm. This endpoint will be compared to historical Pinnacle data | 6 weeks | 
| Z-axis translation of acetabular shell at 6 weeks | RSA measured Z-axis translation of acetabular shell in mm. This endpoint will be compared to historical Pinnacle data | 6 weeks | 
| X-axis rotation of the acetabular shell at 6 weeks | RSA measured X-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data | 6 weeks | 
| Y-axis rotation of the acetabular shell at 6 weeks | RSA measured Y-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data | 6 weeks | 
| Z-axis rotation of the acetabular shell at 6 weeks | RSA measured Z-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data | 6 weeks | 
| Maximal total point motion of the acetabular shell at 6 weeks | RSA measured maximal total point motion of the acetabular shell in mm. This endpoint will be compared to historical Pinnacle data | 6 weeks | 
| Harris Hip Score at 6 weeks | Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome. This endpoint will be compared to historical Pinnacle data | 6 weeks | 
| HOOS Jr. Score at 6 weeks | Functional and health status as measured with the HOOS Jr. score. This is a short version of the HOOS (hip disability and osteoarthritis outcome score) that has a result range of 0-100. A score of 0 indicates total hip disability and 100 indicates perfect hip health. This endpoint will be compared to historical Pinnacle data | 6 weeks | 
| FJS-12 at 6 weeks | Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result. This endpoint will be compared to historical Pinnacle data | 6 weeks |