Pinnacle RSA Study

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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis; Degenerative Arthritis
• Intervention / Treatment: Device: THA

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Panozzo; Phone Number: 574-372-5939; Email: mpanozzo@its.jnj.com

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • QEII Health Sciences Centre & Dalhousie University
  • Ontario
    • London, Ontario, Canada
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. 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
3. Individuals who are willing and able to return for follow-up as specified by the study protocol
4. Individuals who are a minimum age of 21 years at the time of consent
5. Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol

Exclusion Criteria:

1. Individuals have active local or systemic infection
2. Individuals who have loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery
3. 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)
4. Individuals with Charcot's or Paget's disease
5. Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA
6. Women that are pregnant or lactating
7. 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
8. Individuals that have amputations in either leg that would impact rehabilitation following surgery
9. Individuals who are bedridden.
10. Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months
11. Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims
12. 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
13. 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
14. Subject has a medical condition with less than 2 years life expectancy
15. Individual has a BMI >45 kg/m2.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Posterior Approach; Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach	Device: THA; Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem
Experimental: Lateral Approach; Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach	Device: THA; Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem
Experimental: Anterior Approach; Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach	Device: THA; Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem

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 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of functional and health status outcomes vs. RSA	Analyses to examine the correlation of functional and health status outcomes vs. RSA observations may be explored	2 years

Collaborators and Investigators

• Sponsor: DePuy Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2019
• Primary Completion (Actual): June 12, 2023
• Study Completion (Actual): June 16, 2023

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: DSJ_2018_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at https://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes