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

DePuy Orthopaedics3 sites in 1 country11 target enrollmentOctober 6, 2022

ConditionsOsteoarthritis Degenerative Arthritis Revision Arthroplasty

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: DePuy Orthopaedics
Enrollment: 11
Locations: 3
Primary Endpoint: Superior Cup Migration
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 6, 2022

End Date

February 9, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

DePuy Orthopaedics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•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.