PINNACLE® DM RSA Study

Osteoarthritis Clinical Trial

— PIN DM  

Official title:

Multi-Center, Non-Controlled, Prospective Radiostereometric Analysis of the PINNACLE® Dual Mobility Construct

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05357664
• Other study ID #: DSJ_2019_02
• Status: Terminated
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: February 9, 2023

Study information

• Verified date: March 2024
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: February 9, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Arthritis
• Osteoarthritis
• Revision Arthroplasty

Intervention

Device:
• Total Hip Arthroplasty
Pinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses
• Revision Total Hip Arthroplasty
Pinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre & Dalhousie University	Halifax	Nova Scotia
Canada	London Health Sciences Centre	London	Ontario
Canada	Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superior Cup Migration	Radiostereometric analysis (RSA) measured mean superior cup migration (Y translation in MM)	2 years
Secondary	Harris Hip Score	The Harris Hip Score (HHS) has 10 items with four subscales comprising a minimum of 0 points and a maximum of 100 points with higher scores representing better function and outcomes. The four subscales include: pain severity, activities of daily living, absence of deformity and range of motion. Scoring is done according to the following: 90-100 = excellent, 80-89 = good, 70-79 = fair, 60-69 = poor, and below 60 is a failed result	6 weeks post operative
Secondary	HOOS Jr Score	Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) assesses patient pain (2 items), and functions of daily living (4 items). Scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating perfect hip health. This is a patient reported joint-specific score designed to evaluate outcomes after total hip arthroplasty	6 weeks
Secondary	FJS-12	The Forgotten Joint Score (FJS-12) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities which suggests a better outcome	6 weeks
Secondary	Linear Head Penetration	Femoral head penetration into the polyethylene liner component will be determined and measured radiographically	6 weeks, 1 year, 2 years
Secondary	RSA Measured Subsidence (Superior Cup Migration)	Superior migration of the acetabular cup will be measured using RSA	3 months, 6 months and 1 year
Secondary	Additional RSA Measurements	Additional RSA measurements (X and Z translations in mm, X, Y, and Z rotations in degrees, and maximal total point motion in mm) at all time points	6 weeks, 3 months, 6 months, 1 year and 2 years