Cup Position in THA With Standard Instruments

Completed

Conditions studied: Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis

In brief

Prospective, global, multicenter study to assess cup position in THA. After written informed consent has been obtained, study evaluations will be collected from the pre-op clinic visit, the operative visit (including discharge), and 6 and 12 weeks postoperatively.

Key facts

Study ID

NCT03189303

Run by

DePuy Orthopaedics

People needed

183

Starts

2017-09-07

Expected to finish

2021-12-14

Last updated by the study team

2022-02-15

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All devices are to be used according to the approved indications
• The patient is undergoing a standard of care hip replacement with the Pinnacle cup and a Corail, Summit, or Actis stem via the posterolateral, anterolateral, or direct lateral approach with the patient in the lateral decubitus position.
• Individuals who are able to speak, read, and comprehend the Informed 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 complete follow-up as specified by the study protocol.
• Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires (i.e., FJS-12, EQ-5D-5L and Hip Evaluation) as specified by the study protocol.
• Individuals who are not bedridden.
• Individuals who are a minimum age of 21 years at the time of consent.

You may not qualify if…

• Active local or systemic infection.
• Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
• 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 fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
• Charcot's or Paget's disease.
• The Subject is a woman who is pregnant or lactating.
• Subject had a contralateral amputation.
• Previous partial hip replacement in affected hip.
• Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
• Contralateral hip was replaced less than 6 months prior to surgery date
• Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
• Subject was diagnosed and is 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 of life expectancy.
• Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.

Where it is running

• Orthopaedic Associates of Michigan — Grand Rapids, Michigan, United States
• Mount Sinai Hospital — New York, New York, United States
• Carolina Orthopaedic and Sports Medicine Center — Gastonia, North Carolina, United States
• Orthopedic Specialists and Sports Medicine — Newark, Ohio, United States
• Lowcountry Orthopaedics & Sports Medicine — Charleston, South Carolina, United States
• Istituto Orthopedico Galeazzi IRCCS — Milan, Italy
• Bravis Hospital — Bergen op Zoom, Netherlands
• Maastricht University Medical Center — Maastricht, Netherlands
• Canisius Wilhelmina Hospital — Nijmegen, Netherlands
• Woodend Hospital — Aberdeen, Scotland, United Kingdom
• Glan Clwyd Hospital — Rhyl, Wales, United Kingdom

Full record on ClinicalTrials.gov

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