PINNACLE® DM RSA Study (PIN DM)

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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis; Degenerative Arthritis; Revision Arthroplasty
• Intervention / Treatment: Device: Total Hip Arthroplasty; Device: Revision Total Hip Arthroplasty

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Terrence D Whalen; Phone Number: 574-404-9399; Email: dwhalen@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:

   1. a severely painful and/or disabled joint (typically due to non-inflammatory degenerative joint disease).
   2. failed previous hip surgery.
   3. or dislocation risks.
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 deficiency in the affected limb rendering the procedure unjustified.
3. 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).
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 who 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 6 months following 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 per the Investigators determination
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 a psychological disorder 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 sever 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.
16. 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

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

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superior Cup Migration	Radiostereometric analysis (RSA) measured mean superior cup migration (Y translation in MM)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score	The Harris Hip Score (HHS) has 10 items with four subscales comprising a minimum of 0 points and a maximum of 100 points with higher scores representing better function and outcomes. The four subscales include: pain severity, activities of daily living, absence of deformity and range of motion. Scoring is done according to the following: 90-100 = excellent, 80-89 = good, 70-79 = fair, 60-69 = poor, and below 60 is a failed result	6 weeks post operative
HOOS Jr Score	Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) assesses patient pain (2 items), and functions of daily living (4 items). Scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating perfect hip health. This is a patient reported joint-specific score designed to evaluate outcomes after total hip arthroplasty	6 weeks
FJS-12	The Forgotten Joint Score (FJS-12) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities which suggests a better outcome	6 weeks
Linear Head Penetration	Femoral head penetration into the polyethylene liner component will be determined and measured radiographically	6 weeks, 1 year, 2 years
RSA Measured Subsidence (Superior Cup Migration)	Superior migration of the acetabular cup will be measured using RSA	3 months, 6 months and 1 year
Additional RSA Measurements	Additional RSA measurements (X and Z translations in mm, X, Y, and Z rotations in degrees, and maximal total point motion in mm) at all time points	6 weeks, 3 months, 6 months, 1 year and 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acetabular cup subsidence with a prior to discharge baseline	Subsidence for subset of subjects where RSA data was obtained prior to discharge. This endpoint will be compared to historical Pinnacle data	24 months
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. This endpoint will be compared to historical Pinnacle data	24 months
Mean change from baseline values of Harris Hip Score, HOOS Jr. and Forgotten Joint Score	Change from baseline values for the study functional and health scores will be calculated from baseline to 24 months	24 months
Safety Analyses	The overall incidence of safety events including intraprosthetic dislocations, intraoperative complications and adverse events will be summarized	24 months

Collaborators and Investigators

• Sponsor: DePuy Orthopaedics
• Investigators: Principal Investigator: Thomas Turgeon, MD, Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): February 9, 2023

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: DSJ_2019_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