Back to resultsContinuation of Patient Follow-up to 2 Years for the Pinnacle RSA and Pinnacle DM RSA Clinical Trials
Primary Purpose
Hip Osteoarthritis
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pinnacle Gription Acetabular Cup
Pinnacle Dual Mobility
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Hip Replacement
Eligibility Criteria
Inclusion Criteria: Individuals who were enrolled on the DSJ_2018_02 and DSJ_2019_02. 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. DSJ-2019-02 only: 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
- Orthopaedic Innovation Centre
- London Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Pinnacle Gription
Pinnacle Dual Mobility
Arm Description
Pinnacle Gription Acetabular Cup
Pinnacle Dual Mobility System
Outcomes
Primary Outcome Measures
Changes in RSA Migrations from baseline(6-week) to 6-month, 1-year and 2-year
Stability over a period of two year measured by migration (mm) with Röntgen Stereometric Analysis
Secondary Outcome Measures
Subsidence profiles
Comparing RSA exams at the specified time points to determine relative movement of the device
Change of functional outcome over 2 year follow-up period (Harris Hip Score)
The Harris Hip Score (HHS) is a score used in total hip arthroplasty, mainly combining range of motion questions with questions regarding daily life activities. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100, any result <70 is considered a poor result; The HHS is an outcome measure administered by a qualified health care professional.
Pain and Function
The Hip Disability and Osteoarthritis Outcome score - joint replacement (HOOS JR) will be used. The HOOS-JR is a joint replacement survey designed to measure pain and function.
Forgotten Joint Score (FJS)
The FJS total score range is 0-100, higher scores indicating the patient is able to forget the joint daily lower degree of joint awareness.
Complications
Evaluate the type and frequency of the complications/adverse events.
Full Information
NCT ID
NCT05930067
First Posted
June 26, 2023
Last Updated
June 26, 2023
Sponsor
Canadian Radiostereometric Analysis Network
Collaborators
DePuy Synthes
1. Study Identification
Unique Protocol Identification Number
NCT05930067
Brief Title
Continuation of Patient Follow-up to 2 Years for the Pinnacle RSA and Pinnacle DM RSA Clinical Trials
Official Title
Continuation of Patient Follow-up to 2 Years for the Pinnacle RSA and Pinnacle DM RSA Clinical Trials
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canadian Radiostereometric Analysis Network
Collaborators
DePuy Synthes
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 proposed study is a continuation of two prospective, multi-centre, non-controlled studies of the Pinnacle and Pinnacle Dual Mobility total hip arthroplasty systems, originally initiated by DePuy Synthes (DSJ_2018_02 and DJS_2019_02, respectively).
Detailed Description
The primary study objective is to establish the mean superior migration of the Pinnacle Gription Sector acetabular cup, irrespective of standard or dual mobility articulation, using model-based radiostereometric analysis. As both prior studies utilize the same acetabular component, a combined analysis will be performed with an additional sub-analysis on those with a Pinnacle Dual Mobility system. Additional objectives include comparison of acetabular cup migration between surgical approach groups (posterolateral, direct lateral, direct anterior) at all time points, linear head penetration at 1 and 2 years, as well as functional and health status outcomes. Patients will be followed to the original end point of 2 years post-surgery using the same radiographic and patient-reported outcome measures at the primary studies; Harris Hip Score, Hip Evaluation, HOOS Jr., and Forgotten Joint Score. Results of this study will be published in orthopaedic journals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
Hip Replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pinnacle Gription
Arm Type
Other
Arm Description
Pinnacle Gription Acetabular Cup
Arm Title
Pinnacle Dual Mobility
Arm Type
Other
Arm Description
Pinnacle Dual Mobility System
Intervention Type
Device
Intervention Name(s)
Pinnacle Gription Acetabular Cup
Intervention Description
Pinnacle Gription cup with Corail/ACTIS stem
Intervention Type
Device
Intervention Name(s)
Pinnacle Dual Mobility
Intervention Description
Bi-Mentum AltrX liner
Primary Outcome Measure Information:
Title
Changes in RSA Migrations from baseline(6-week) to 6-month, 1-year and 2-year
Description
Stability over a period of two year measured by migration (mm) with Röntgen Stereometric Analysis
Time Frame
Post-op: 6-weeks, 3-months, 6-months, 1-year, 2-year
Secondary Outcome Measure Information:
Title
Subsidence profiles
Description
Comparing RSA exams at the specified time points to determine relative movement of the device
Time Frame
6-months, 1-year, 2-year
Title
Change of functional outcome over 2 year follow-up period (Harris Hip Score)
Description
The Harris Hip Score (HHS) is a score used in total hip arthroplasty, mainly combining range of motion questions with questions regarding daily life activities. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100, any result <70 is considered a poor result; The HHS is an outcome measure administered by a qualified health care professional.
Time Frame
Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
Title
Pain and Function
Description
The Hip Disability and Osteoarthritis Outcome score - joint replacement (HOOS JR) will be used. The HOOS-JR is a joint replacement survey designed to measure pain and function.
Time Frame
Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
Title
Forgotten Joint Score (FJS)
Description
The FJS total score range is 0-100, higher scores indicating the patient is able to forget the joint daily lower degree of joint awareness.
Time Frame
Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
Title
Complications
Description
Evaluate the type and frequency of the complications/adverse events.
Time Frame
Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Individuals who were enrolled on the DSJ_2018_02 and DSJ_2019_02.
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.
DSJ-2019-02 only: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Turgeon, MD
Organizational Affiliation
Concordia Joint Replacement Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic Innovation Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2K 2M9
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Continuation of Patient Follow-up to 2 Years for the Pinnacle RSA and Pinnacle DM RSA Clinical Trials
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