search
Back to results

Pinnacle RSA Study

Primary Purpose

Osteoarthritis, Degenerative Arthritis

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
THA
Sponsored by
DePuy Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba
  • QEII Health Sciences Centre & Dalhousie University
  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Posterior Approach

Lateral Approach

Anterior Approach

Arm Description

Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach

Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach

Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 24, 2019
Last Updated
July 26, 2023
Sponsor
DePuy Orthopaedics
search

1. Study Identification

Unique Protocol Identification Number
NCT04070989
Brief Title
Pinnacle RSA Study
Official Title
Multi-Center, Non-controlled, Prospective Radiostereometric Analysis of the Pinnacle Acetabular Shell
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision to terminate early. Decision was not based on safety or efficacy of the study product.
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
June 12, 2023 (Actual)
Study Completion Date
June 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Orthopaedics

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Degenerative Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Posterior Approach
Arm Type
Experimental
Arm Description
Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach
Arm Title
Lateral Approach
Arm Type
Experimental
Arm Description
Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach
Arm Title
Anterior Approach
Arm Type
Experimental
Arm Description
Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach
Intervention Type
Device
Intervention Name(s)
THA
Intervention Description
Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem
Primary Outcome Measure Information:
Title
Mean superior cup migration (subsidence) at 2 years
Description
RSA measured mean superior cup migration (subsidence: Y translation in mm) at 2 years for each surgical approach separately, as well as combined
Time Frame
2 years
Secondary Outcome Measure Information:
Title
RSA measured cup subsidence at 3 months
Description
RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell
Time Frame
3 months
Title
X-axis translation of acetabular shell at 3 months
Description
RSA measured X-axis translation of acetabular shell in mm
Time Frame
3 months
Title
Z-axis translation of acetabular shell at 3 months
Description
RSA measured Z-axis translation of acetabular shell in mm
Time Frame
3 months
Title
X-axis rotation of the acetabular shell at 3 months
Description
RSA measured X-axis rotation of the acetabular shell measured in degrees
Time Frame
3 months
Title
Y-axis rotation of the acetabular shell at 3 months
Description
RSA measured Y-axis rotation of the acetabular shell measured in degrees
Time Frame
3 months
Title
Z-axis rotation of the acetabular shell at 3 months
Description
RSA measured Z-axis rotation of the acetabular shell measured in degrees
Time Frame
3 months
Title
Maximal total point motion of the acetabular shell at 3 months
Description
RSA measured maximal total point motion of the acetabular shell in mm
Time Frame
3 months
Title
Harris Hip Score at 3 months
Description
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.
Time Frame
3 months
Title
HOOS Jr. Score at 3 months
Description
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.
Time Frame
3 months
Title
FJS-12 at 3 months
Description
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.
Time Frame
3 months
Title
RSA measured cup subsidence at 6 months
Description
RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell
Time Frame
6 months
Title
X-axis translation of acetabular shell at 6 months
Description
RSA measured X-axis translation of acetabular shell in mm
Time Frame
6 months
Title
Z-axis translation of acetabular shell at 6 months
Description
RSA measured Z-axis translation of acetabular shell in mm
Time Frame
6 months
Title
X-axis rotation of the acetabular shell at 6 months
Description
RSA measured X-axis rotation of the acetabular shell measured in degrees
Time Frame
6 months
Title
Y-axis rotation of the acetabular shell at 6 months
Description
RSA measured Y-axis rotation of the acetabular shell measured in degrees
Time Frame
6 months
Title
Z-axis rotation of the acetabular shell at 6 months
Description
RSA measured Z-axis rotation of the acetabular shell measured in degrees
Time Frame
6 months
Title
Maximal total point motion of the acetabular shell at 6 months
Description
RSA measured maximal total point motion of the acetabular shell in mm
Time Frame
6 months
Title
Harris Hip Score at 6 months
Description
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.
Time Frame
6 months
Title
HOOS Jr. Score at 6 months
Description
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.
Time Frame
6 months
Title
FJS-12 at 6 months
Description
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.
Time Frame
6 months
Title
RSA measured cup subsidence at 1 year
Description
RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell
Time Frame
1 year
Title
X-axis translation of acetabular shell at 1 year
Description
RSA measured X-axis translation of acetabular shell in mm
Time Frame
1 year
Title
Z-axis translation of acetabular shell at 1 year
Description
RSA measured Z-axis translation of acetabular shell in mm
Time Frame
1 year
Title
X-axis rotation of the acetabular shell at 1 year
Description
RSA measured X-axis rotation of the acetabular shell measured in degrees
Time Frame
1 year
Title
Y-axis rotation of the acetabular shell at 1 year
Description
RSA measured Y-axis rotation of the acetabular shell measured in degrees
Time Frame
1 year
Title
Z-axis rotation of the acetabular shell at 1 year
Description
RSA measured Z-axis rotation of the acetabular shell measured in degrees
Time Frame
1 year
Title
Maximal total point motion of the acetabular shell at 1 year
Description
RSA measured maximal total point motion of the acetabular shell in mm
Time Frame
1 year
Title
Harris Hip Score at 1 year
Description
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.
Time Frame
1 year
Title
HOOS Jr. Score at 1 year
Description
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.
Time Frame
1 year
Title
FJS-12 at 1 year
Description
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.
Time Frame
1 year
Title
X-axis translation of acetabular shell at 2 years
Description
RSA measured X-axis translation of acetabular shell in mm
Time Frame
2 years
Title
Z-axis translation of acetabular shell at 2 years
Description
RSA measured Z-axis translation of acetabular shell in mm
Time Frame
2 years
Title
X-axis rotation of the acetabular shell at 2 years
Description
RSA measured X-axis rotation of the acetabular shell measured in degrees
Time Frame
2 years
Title
Y-axis rotation of the acetabular shell at 2 years
Description
RSA measured Y-axis rotation of the acetabular shell measured in degrees
Time Frame
2 years
Title
Z-axis rotation of the acetabular shell at 2 years
Description
RSA measured Z-axis rotation of the acetabular shell measured in degrees
Time Frame
2 years
Title
Maximal total point motion of the acetabular shell at 2 years
Description
RSA measured maximal total point motion of the acetabular shell in mm
Time Frame
2 years
Title
Harris Hip Score at 2 years
Description
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.
Time Frame
2 years
Title
HOOS Jr. Score at 2 years
Description
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.
Time Frame
2 years
Title
FJS-12 at 2 years
Description
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.
Time Frame
2 years
Title
Linear head penetration at 1 year
Description
Amount of linear head penetration compared to baseline (6 weeks) measured in mm
Time Frame
1 year
Title
Linear head penetration at 2 years
Description
Amount of linear head penetration compared to baseline (6 weeks) measured in mm
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Correlation of functional and health status outcomes vs. RSA
Description
Analyses to examine the correlation of functional and health status outcomes vs. RSA observations may be explored
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
QEII Health Sciences Centre & Dalhousie University
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
http://yoda.yale.edu

Learn more about this trial

Pinnacle RSA Study

We'll reach out to this number within 24 hrs