Clinical trial NCT05357664: PINNACLE® DM RSA Study
Official title: Multi-Center, Non-Controlled, Prospective Radiostereometric Analysis of the PINNACLE® Dual Mobility Construct
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Degenerative Arthritis
Revision Arthroplasty
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2022-05-03
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Individuals requiring primary THA for:

   1. a severely painful and/or disabled joint (typically due to non-inflammatory degenerative joint disease).
   2. failed previous hip surgery.
   3. or dislocation risks.
2. 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.
3. Individuals who are willing and able to return for follow-up as specified by the study protocol.
4. Individuals who are a minimum age of 21 years at the time of consent.
5. Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol.

   -

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.
8. Individuals that have amputations in either leg that would impact rehabilitation following surgery.
9. Individuals who are bedridden per the Investigators determination
10. Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.
11. Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
12. 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.
13. 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.
14. Subject has a medical condition with less than 2 years life expectancy.
15. Individual has a BMI \>45 kg/m2.
16. 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: Superior Cup Migration
timeFrame: 2 years
Secondary outcomes:
measure: Harris Hip Score
timeFrame: 6 weeks post operative
measure: HOOS Jr Score
timeFrame: 6 weeks
measure: FJS-12
timeFrame: 6 weeks
measure: Linear Head Penetration
timeFrame: 6 weeks, 1 year, 2 years
measure: RSA Measured Subsidence (Superior Cup Migration)
timeFrame: 3 months, 6 months and 1 year
measure: Additional RSA Measurements
timeFrame: 6 weeks, 3 months, 6 months, 1 year and 2 years
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: QEII Health Sciences Centre & Dalhousie University
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba
name: Thomas Turgeon, MD
role: PRINCIPAL_INVESTIGATOR
References: