Continuation of Patient Follow-up to 2 Years for the Pinnacle RSA and Pinnacle DM RSA Clinical Trials
- Conditions
- Hip Osteoarthritis
- Interventions
- Device: Pinnacle Dual MobilityDevice: Pinnacle Gription Acetabular Cup
- Registration Number
- NCT05930067
- Lead Sponsor
- Canadian Radiostereometric Analysis Network
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 82
- Individuals who were enrolled on the DSJ_2018_02 and DSJ_2019_02.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pinnacle Dual Mobility Pinnacle Dual Mobility Pinnacle Dual Mobility System Pinnacle Gription Pinnacle Gription Acetabular Cup Pinnacle Gription Acetabular Cup
- Primary Outcome Measures
Name Time Method 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
Name Time Method Complications Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively Evaluate the type and frequency of the complications/adverse events.
Subsidence profiles 6-months, 1-year, 2-year Comparing RSA exams at the specified time points to determine relative movement of the device
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.
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.
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.
Trial Locations
- Locations (2)
Orthopaedic Innovation Centre
🇨🇦Winnipeg, Manitoba, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada