Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty with Standard Instrumentation and Technique - DSJ_15010: Cup Position in THA with Standard Instruments

Medical Device Business Services, Inc. (DePuy Synthes)0 个研究点目标入组 54 人开始时间: 待定最近更新: 2024年4月15日

试验速览

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•1) All devices are to be used according to the approved indications
•2) 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.
•3) 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.
•4) Individuals who are willing and able to complete follow-up as specified by
•the study protocol.
•5) 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.
•6) Individuals who are not bedridden.
•7) Individuals who are a minimum age of 21 years at the time of consent.

•1) Active local or systemic infection.
•2) Loss of musculature, neuromuscular compromise or vascular deficiency in the
•affected limb rendering the procedure unjustified.
•3) 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).
•4) Charcot*s or Paget*s disease.
•5) The Subject is a woman who is pregnant or lactating.
•6) Subject had a contralateral amputation.
•7) Previous partial hip replacement in affected hip.
•8) Subject has participated in a clinical investigation with an investigational
•product (drug or device) in the last three months.
•9) Contralateral hip was replaced less than 6 months prior to surgery date
•10) Subject is currently involved in any personal injury litigation,
•medical-legal or worker*s compensation claims.
•11) 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.
•12) Subject has a medical condition with less than 2 years of life expectancy.
•13) 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.

发起方

Medical Device Business Services, Inc. (DePuy Synthes)