Continuation of Patient Follow-up to 2 Years for the Pinnacle RSA and Pinnacle DM RSA Clinical Trials
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Pinnacle Gription Pinnacle Gription Acetabular Cup |
Device: Pinnacle Gription Acetabular Cup
Pinnacle Gription cup with Corail/ACTIS stem
|
| Other: Pinnacle Dual Mobility Pinnacle Dual Mobility System |
Device: Pinnacle Dual Mobility
Bi-Mentum AltrX liner
|
Outcome Measures
Primary Outcome Measures
- Changes in RSA Migrations from baseline(6-week) to 6-month, 1-year and 2-year [Post-op: 6-weeks, 3-months, 6-months, 1-year, 2-year]
Stability over a period of two year measured by migration (mm) with Röntgen Stereometric Analysis
Secondary Outcome Measures
- Subsidence profiles [6-months, 1-year, 2-year]
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) [Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively]
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 [Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively]
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) [Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively]
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 [Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively]
Evaluate the type and frequency of the complications/adverse events.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Individuals who were enrolled on the DSJ_2018_02 and DSJ_2019_02.
Exclusion Criteria:
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Individuals have active local or systemic infection.
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Individuals who have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
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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).
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Individuals with Charcot's or Paget's disease.
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Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA.
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Women who are pregnant or lactating.
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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.
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Individuals who are bedridden per the Investigators determination.
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Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.
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Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
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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.
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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.
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Subject has a medical condition with less than 2 years life expectancy.
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Individual has a BMI >45 kg/m2.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orthopaedic Innovation Centre | Winnipeg | Manitoba | Canada | R2K 2M9 |
| 2 | London Health Sciences Centre | London | Ontario | Canada | N6A 5W9 |
Sponsors and Collaborators
- Canadian Radiostereometric Analysis Network
- DePuy Synthes
Investigators
- Principal Investigator: Thomas Turgeon, MD, Concordia Joint Replacement Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS23122 - HS25079