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Clinical Trials/NL-OMON47358
NL-OMON47358
Completed
Phase 4

A prospective, multicenter, non-randomized, clinical outcome study of the R3 acetabular System in patients with degenerative hip disease. - Prospective R3 outcome study

Smith & Nephew Orthopedics AG0 sites50 target enrollmentTBD
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Conditionsosteoarthritisreumatoid arthritis1002321310005944

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
osteoarthritis
Sponsor
Smith & Nephew Orthopedics AG
Enrollment
50
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational non invasive

Investigators

Sponsor
Smith & Nephew Orthopedics AG

Eligibility Criteria

Inclusion Criteria

  • •\* Patient requires primary total hip arthroplasty due to non\-inflammatory
  • •degenerative joint disease (e.g. osteoarthritis, post\-traumatic arthritis, avascular necrosis, dysplasia/DDH) or inflammatory joint disease (e.g., rheumatoid arthritis)
  • •\* Patient has met an acceptable preoperative medical clearance and is free from
  • •or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk
  • •\* The patient is willing to comply the follow\-up schedule
  • •Patient is 18\-75 years old and he/she is skeletally mature

Exclusion Criteria

  • •\* Patient has active infection or sepsis (treated or untreated)
  • •\* Patient is a prisoner or has an emotional or neurological condition that would
  • •pre\-empt their ability or unwillingness to participate in the study including mental illness, mental retardation, linguistic insufficiencies (i.e. immigrants), or drug/alcohol abuse.
  • •\* Patients with acute hip trauma (femoral neck fracture)

Outcomes

Primary Outcomes

Not specified

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