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Pinnacle RSA Study | Clinical Trials | Clareo Health

TERMINATEDNA

Pinnacle RSA Study

Multi-Center, Non-controlled, Prospective Radiostereometric Analysis of the Pinnacle Acetabular Shell

NCT04070989•DePuy Orthopaedics

Summary

The primary objective is to establish the mean superior cup migration of the Pinnacle Acetabular Shell 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. This will be summarized for each surgical approach separately, as well as combined.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Individuals requiring primary THA for a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, AVN of the femoral head or acute traumatic fracture of the femoral head or neck
•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 compromise that would impact rehabilitation following surgery
•3. Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or require additional acetabular cup fixation using screws, or a significant chance of fracture of the femoral shaft 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 that 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 following 6 months at 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.
•10. Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months
+5 more criteria

Locations (3)

Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba

Winnipeg, Manitoba, Canada

QEII Health Sciences Centre & Dalhousie University

Halifax, Nova Scotia, Canada

London Health Sciences Centre

London, Ontario, Canada

Key Dates

Start Date

December 3, 2019

Primary Completion Date

June 12, 2023

Completion Date

June 16, 2023

Last Updated

December 19, 2025

Enrollment

100

ACTUAL participants

Conditions

OsteoarthritisDegenerative Arthritis

Interventions

THA

DEVICE

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

NCT07153471

Osteoarthritis

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RECRUITINGPHASE1

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

NCT07351968

Moderate Pain in Knee OsteoarthritisSevere Pain in Knee Osteoarthritis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pinnacle RSA Study

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

CBD for Pain Following Orthopedic Shoulder Surgery

General vs Spinal in Total Joint Arthroplasty (TJA)

PENG Block Variants With Dexamethasone and Dexmedetomidine in Older Adults

A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression