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Clinical Trials/NL-OMON50733
NL-OMON50733
Completed
N/A

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 sites54 target enrollmentTBD
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Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Medical Device Business Services, Inc. (DePuy Synthes)
Enrollment
54
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
Medical Device Business Services, Inc. (DePuy Synthes)

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Not specified

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