Continuation of Patient Follow-up to 2 Years for the Pinnacle RSA and Pinnacle DM RSA Clinical Trials

NCT05930067 | Completed FDA Device

• 1 other identifier: HS23122 - HS25079
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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).

Conditions

Hip Osteoarthritis

Keywords

Hip Replacement

Outcome Measures

Primary Outcomes (1)

• Changes in RSA Migrations from baseline(6-week) to 6-month, 1-year and 2-year

  Stability over a period of two year measured by migration (mm) with Röntgen Stereometric Analysis

  Post-op: 6-weeks, 3-months, 6-months, 1-year, 2-year

Secondary Outcomes (5)

• Subsidence profiles

  6-months, 1-year, 2-year

• 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

• Pain and Function

  Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively

• Forgotten Joint Score (FJS)

  Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively

• Complications

  Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively

Study Arms (2)

Pinnacle Gription

OTHER

Pinnacle Gription Acetabular Cup

Device: Pinnacle Gription Acetabular Cup

Pinnacle Dual Mobility

OTHER

Pinnacle Dual Mobility System

Device: Pinnacle Dual Mobility

Interventions

Pinnacle Gription Acetabular Cup DEVICE

Pinnacle Gription cup with Corail/ACTIS stem

Pinnacle Gription

Pinnacle Dual Mobility DEVICE

Bi-Mentum AltrX liner

Pinnacle Dual Mobility

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who were enrolled on the DSJ\_2018\_02 and DSJ\_2019\_02.

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Radiostereometric Analysis Network: lead
• DePuy Synthes: collaborator

Study Sites (2)

Orthopaedic Innovation Centre

Winnipeg, Manitoba, R2K 2M9, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Thomas Turgeon, MD

  Concordia Joint Replacement Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 5, 2023
• Study Start: May 2, 2023
• Primary Completion: March 12, 2025
• Study Completion: May 30, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

CA (2)