Clinical trial NCT05930067: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: Hip Replacement
Lead sponsor: Canadian Radiostereometric Analysis Network
Sponsor class: OTHER
Collaborators: name: DePuy Synthes
First posted: 2023-07-05
Enrollment: 82
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Individuals who were enrolled on the DSJ_2018_02 and DSJ_2019_02.

Exclusion Criteria:

1. Individuals have active local or systemic infection.
2. Individuals who have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
3. 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).
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 who 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 6 months following the time of consent into this study. Individuals that have amputations in either leg that would impact rehabilitation following surgery.
8. Individuals who are bedridden per the Investigators determination.
9. Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.
10. Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
11. 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.
12. 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.
13. Subject has a medical condition with less than 2 years life expectancy.
14. Individual has a BMI \>45 kg/m2.
15. 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

Primary outcomes:
measure: Changes in RSA Migrations from baseline(6-week) to 6-month, 1-year and 2-year
timeFrame: Post-op: 6-weeks, 3-months, 6-months, 1-year, 2-year
Secondary outcomes:
measure: Subsidence profiles
timeFrame: 6-months, 1-year, 2-year
measure: Change of functional outcome over 2 year follow-up period (Harris Hip Score)
timeFrame: Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
measure: Pain and Function
timeFrame: Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
measure: Forgotten Joint Score (FJS)
timeFrame: Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
measure: Complications
timeFrame: Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Orthopaedic Innovation Centre
state: Manitoba
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Concordia Joint Replacement Group
name: Thomas Turgeon, MD
role: PRINCIPAL_INVESTIGATOR
References: