Back to resultsPINNACLE® DM RSA Study (PIN DM)
Primary Purpose
Osteoarthritis, Degenerative Arthritis, Revision Arthroplasty
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Total Hip Arthroplasty
Revision Total Hip Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
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
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 Type
Experimental
Experimental
Arm Label
Total Hip Arthroplasty
Revision Total Hip Arthroplasty
Arm Description
Pinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses
Pinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses
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. This endpoint will be compared to historical Pinnacle data
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05357664
Brief Title
PINNACLE® DM RSA Study
Acronym
PIN DM
Official Title
Multi-Center, Non-Controlled, Prospective Radiostereometric Analysis of the PINNACLE® Dual Mobility Construct
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Business decision made not to fund study
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
January 17, 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® 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Degenerative Arthritis, Revision Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Total Hip Arthroplasty
Arm Type
Experimental
Arm Description
Pinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses
Arm Title
Revision Total Hip Arthroplasty
Arm Type
Experimental
Arm Description
Pinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses
Intervention Type
Device
Intervention Name(s)
Total Hip Arthroplasty
Other Intervention Name(s)
THA
Intervention Description
Pinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses
Intervention Type
Device
Intervention Name(s)
Revision Total Hip Arthroplasty
Other Intervention Name(s)
RTHA
Intervention Description
Pinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses
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. This endpoint will be compared to historical Pinnacle data
Time Frame
24 months
Secondary Outcome Measure Information:
Title
RSA measured cup subsidence at 3 months
Description
RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
Time Frame
3 months
Title
RSA measured cup subsidence at 12 months
Description
RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell. This endpoint will be compared to historical Pinnacle data
Time Frame
12 months
Title
X-axis translation of acetabular shell at 12 months
Description
RSA measured X-axis translation of acetabular shell in mm. This endpoint will be compared to historical Pinnacle data
Time Frame
12 months
Title
Z-axis translation of acetabular shell at 12 months
Description
RSA measured Z-axis translation of acetabular shell in mm. This endpoint will be compared to historical Pinnacle data
Time Frame
12 months
Title
X-axis rotation of the acetabular shell at 12 months
Description
RSA measured X-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data
Time Frame
12 months
Title
Y-axis rotation of the acetabular shell at 12 months
Description
RSA measured Y-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data
Time Frame
12 months
Title
Z-axis rotation of the acetabular shell at 12 months
Description
RSA measured Z-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data
Time Frame
12 months
Title
Maximal total point motion of the acetabular shell at 12 months
Description
RSA measured maximal total point motion of the acetabular shell in mm. This endpoint will be compared to historical Pinnacle data
Time Frame
12 months
Title
Harris Hip Score at 12 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. This endpoint will be compared to historical Pinnacle data
Time Frame
12 months
Title
HOOS Jr. Score at 12 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. This endpoint will be compared to historical Pinnacle data
Time Frame
12 months
Title
FJS-12 at 12 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. This endpoint will be compared to historical Pinnacle data
Time Frame
12 months
Title
RSA measured cup subsidence at 6 months
Description
RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
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. This endpoint will be compared to historical Pinnacle data
Time Frame
6 months
Title
RSA measured cup subsidence at 24 months
Description
RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell. This endpoint will be compared to historical Pinnacle data
Time Frame
24 months
Title
X-axis translation of acetabular shell at 24 months
Description
RSA measured X-axis translation of acetabular shell in mm. This endpoint will be compared to historical Pinnacle data
Time Frame
24 months
Title
Z-axis translation of acetabular shell at 24 months
Description
RSA measured Z-axis translation of acetabular shell in mm. This endpoint will be compared to historical Pinnacle data
Time Frame
24 months
Title
X-axis rotation of the acetabular shell at 24 months
Description
RSA measured X-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data
Time Frame
24 months
Title
Y-axis rotation of the acetabular shell at 24 months
Description
RSA measured Y-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data
Time Frame
24 months
Title
Z-axis rotation of the acetabular shell at 24 months
Description
RSA measured Z-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data
Time Frame
24 months
Title
Maximal total point motion of the acetabular shell at 24 months
Description
RSA measured maximal total point motion of the acetabular shell in mm. This endpoint will be compared to historical Pinnacle data
Time Frame
24 months
Title
Harris Hip Score at 24 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. This endpoint will be compared to historical Pinnacle data
Time Frame
24 months
Title
HOOS Jr. Score at 24 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. This endpoint will be compared to historical Pinnacle data
Time Frame
24 months
Title
FJS-12 at 24 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. This endpoint will be compared to historical Pinnacle data
Time Frame
24 months
Title
Cup Positioning at 6 weeks
Description
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
Time Frame
6 weeks
Title
Cup Positioning at 12 months
Description
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
Time Frame
12 months
Title
Cup Positioning at 24 months
Description
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
Time Frame
24 months
Title
X-axis translation of acetabular shell at 6 weeks
Description
RSA measured X-axis translation of acetabular shell in mm. This endpoint will be compared to historical Pinnacle data
Time Frame
6 weeks
Title
Z-axis translation of acetabular shell at 6 weeks
Description
RSA measured Z-axis translation of acetabular shell in mm. This endpoint will be compared to historical Pinnacle data
Time Frame
6 weeks
Title
X-axis rotation of the acetabular shell at 6 weeks
Description
RSA measured X-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data
Time Frame
6 weeks
Title
Y-axis rotation of the acetabular shell at 6 weeks
Description
RSA measured Y-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data
Time Frame
6 weeks
Title
Z-axis rotation of the acetabular shell at 6 weeks
Description
RSA measured Z-axis rotation of the acetabular shell measured in degrees. This endpoint will be compared to historical Pinnacle data
Time Frame
6 weeks
Title
Maximal total point motion of the acetabular shell at 6 weeks
Description
RSA measured maximal total point motion of the acetabular shell in mm. This endpoint will be compared to historical Pinnacle data
Time Frame
6 weeks
Title
Harris Hip Score at 6 weeks
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. This endpoint will be compared to historical Pinnacle data
Time Frame
6 weeks
Title
HOOS Jr. Score at 6 weeks
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. This endpoint will be compared to historical Pinnacle data
Time Frame
6 weeks
Title
FJS-12 at 6 weeks
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. This endpoint will be compared to historical Pinnacle data
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Acetabular cup subsidence with a prior to discharge baseline
Description
Subsidence for subset of subjects where RSA data was obtained prior to discharge. This endpoint will be compared to historical Pinnacle data
Time Frame
24 months
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. This endpoint will be compared to historical Pinnacle data
Time Frame
24 months
Title
Mean change from baseline values of Harris Hip Score, HOOS Jr. and Forgotten Joint Score
Description
Change from baseline values for the study functional and health scores will be calculated from baseline to 24 months
Time Frame
24 months
Title
Safety Analyses
Description
The overall incidence of safety events including intraprosthetic dislocations, intraoperative complications and adverse events will be summarized
Time Frame
24 months
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 (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
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® DM RSA Study
We'll reach out to this number within 24 hrs