Pinnacle RSA Study

Study Overview
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Brief Summary
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The primary objective is to establish the mean superior cup migration of the Pinnacle Acetabular Shell 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. This will be summarized for each surgical approach separately, as well as combined.

Official Title
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Multi-Center, Non-controlled, Prospective Radiostereometric Analysis of the Pinnacle Acetabular Shell

Conditions
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Osteoarthritis, Degenerative Arthritis

Intervention / Treatment
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* Device: THA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals requiring primary THA for a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, AVN of the femoral head or acute traumatic fracture of the femoral head or neck 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 compromise that would impact rehabilitation following surgery Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or require additional acetabular cup fixation using screws, or a significant chance of fracture of the femoral shaft 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 that 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 following 6 months at the time of consent into this study Individuals that have amputations in either leg that would impact rehabilitation following surgery Individuals who are bedridden. 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 psychological disorders 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 severe 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.

Ages Eligible for Study
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Minimum Age: 21 Years

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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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: Posterior Approach<br>Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach | Device: THA<br>* Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem<br>|
| Experimental: Lateral Approach<br>Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach | Device: THA<br>* Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem<br>|
| Experimental: Anterior Approach<br>Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach | Device: THA<br>* Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem<br>|

What is the study measuring?
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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 for each surgical approach separately, as well as combined | 2 years | 

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 | 3 months | 
| X-axis translation of acetabular shell at 3 months | RSA measured X-axis translation of acetabular shell in mm | 3 months | 
| Z-axis translation of acetabular shell at 3 months | RSA measured Z-axis translation of acetabular shell in mm | 3 months | 
| X-axis rotation of the acetabular shell at 3 months | RSA measured X-axis rotation of the acetabular shell measured in degrees | 3 months | 
| Y-axis rotation of the acetabular shell at 3 months | RSA measured Y-axis rotation of the acetabular shell measured in degrees | 3 months | 
| Z-axis rotation of the acetabular shell at 3 months | RSA measured Z-axis rotation of the acetabular shell measured in degrees | 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 | 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. | 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. | 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. | 3 months | 
| RSA measured cup subsidence at 6 months | RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell | 6 months | 
| X-axis translation of acetabular shell at 6 months | RSA measured X-axis translation of acetabular shell in mm | 6 months | 
| Z-axis translation of acetabular shell at 6 months | RSA measured Z-axis translation of acetabular shell in mm | 6 months | 
| X-axis rotation of the acetabular shell at 6 months | RSA measured X-axis rotation of the acetabular shell measured in degrees | 6 months | 
| Y-axis rotation of the acetabular shell at 6 months | RSA measured Y-axis rotation of the acetabular shell measured in degrees | 6 months | 
| Z-axis rotation of the acetabular shell at 6 months | RSA measured Z-axis rotation of the acetabular shell measured in degrees | 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 | 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. | 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. | 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. | 6 months | 
| RSA measured cup subsidence at 1 year | RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell | 1 year | 
| X-axis translation of acetabular shell at 1 year | RSA measured X-axis translation of acetabular shell in mm | 1 year | 
| Z-axis translation of acetabular shell at 1 year | RSA measured Z-axis translation of acetabular shell in mm | 1 year | 
| X-axis rotation of the acetabular shell at 1 year | RSA measured X-axis rotation of the acetabular shell measured in degrees | 1 year | 
| Y-axis rotation of the acetabular shell at 1 year | RSA measured Y-axis rotation of the acetabular shell measured in degrees | 1 year | 
| Z-axis rotation of the acetabular shell at 1 year | RSA measured Z-axis rotation of the acetabular shell measured in degrees | 1 year | 
| Maximal total point motion of the acetabular shell at 1 year | RSA measured maximal total point motion of the acetabular shell in mm | 1 year | 
| Harris Hip Score at 1 year | 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. | 1 year | 
| HOOS Jr. Score at 1 year | 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. | 1 year | 
| FJS-12 at 1 year | 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. | 1 year | 
| X-axis translation of acetabular shell at 2 years | RSA measured X-axis translation of acetabular shell in mm | 2 years | 
| Z-axis translation of acetabular shell at 2 years | RSA measured Z-axis translation of acetabular shell in mm | 2 years | 
| X-axis rotation of the acetabular shell at 2 years | RSA measured X-axis rotation of the acetabular shell measured in degrees | 2 years | 
| Y-axis rotation of the acetabular shell at 2 years | RSA measured Y-axis rotation of the acetabular shell measured in degrees | 2 years | 
| Z-axis rotation of the acetabular shell at 2 years | RSA measured Z-axis rotation of the acetabular shell measured in degrees | 2 years | 
| Maximal total point motion of the acetabular shell at 2 years | RSA measured maximal total point motion of the acetabular shell in mm | 2 years | 
| Harris Hip Score at 2 years | 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. | 2 years | 
| HOOS Jr. Score at 2 years | 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. | 2 years | 
| FJS-12 at 2 years | 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. | 2 years | 
| Linear head penetration at 1 year | Amount of linear head penetration compared to baseline (6 weeks) measured in mm | 1 year | 
| Linear head penetration at 2 years | Amount of linear head penetration compared to baseline (6 weeks) measured in mm | 2 years |