Pinnacle RSA Study

  • End date
    Jan 6, 2025
  • participants needed
  • sponsor
    DePuy Orthopaedics
Updated on 3 April 2023
rheumatoid arthritis
traumatic arthritis
congenital hip dysplasia


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.

Condition Osteoarthritis, Degenerative Arthritis
Treatment THA, THA
Clinical Study IdentifierNCT04070989
SponsorDePuy Orthopaedics
Last Modified on3 April 2023


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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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