Pinnacle RSA Study

STATUS

Recruiting
End date

Jan 6, 2025
participants needed

90
sponsor

DePuy Orthopaedics

Updated on 3 April 2023

See if I qualify

rheumatoid arthritis

traumatic arthritis

congenital hip dysplasia

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.

Details

Condition	Osteoarthritis, Degenerative Arthritis
Treatment	THA, THA
Clinical Study Identifier	NCT04070989
Sponsor	DePuy Orthopaedics
Last Modified on	3 April 2023

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
	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 compromise that would impact rehabilitation following surgery
	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)
	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 that 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 following 6 months at the time of consent into this study
	Individuals that have amputations in either leg that would impact rehabilitation following surgery
	Individuals who are bedridden
	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 psychological disorders 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 severe 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

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Study Definition

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Pinnacle RSA Study