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Status:

ACTIVE_NOT_RECRUITING

Exception Cementless Hip Stem

Lead Sponsor:

Zimmer Biomet

Conditions:

Osteoarthritis, Hip

Rheumatoid Arthritis

Eligibility:

All Genders

18-100 years

Brief Summary

This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study. The objectives of this study are to confirm the long-term safety, perfo...

Detailed Description

Six surgeons have prospectively collected clinical data for patients operated consecutively between January 2008 and September 2012. The patients have been operated based on the indications and contra...

Eligibility Criteria

Inclusion

  • At the time of surgery, the inclusion criteria were based on the indications presented in the IFUs:
  • Primary or secondary osteoarthritis
  • Inflammatory impairment of the hip, rheumatoid arthritis, etc.
  • Fracture of the neck of the femur
  • Avascular necrosis of the femoral head
  • Sequelae from previous operations on the hip, osteotomies, etc.
  • Congenital hip dysplasia.
  • Patient is older than 18 years old
  • Patient had consented to the original data collection after his/her surgery
  • At the time of surgery, the exclusion criteria were based on the contraindications presented in the IFUs:
  • Local or systemic infections.
  • Serious muscular, neurological or vascular deficiencies in the limb concerned.
  • Bone destruction or poor quality bone likely to affect the stability of the implant (Paget's disease, osteoporosis, etc.)
  • Any concomitant disorder likely to affect the function of the implant.
  • Allergy to one of the implant components.
  • Patients weighing more than 110 kg.
  • Patient incapable of following the recommendations of the surgeon

Exclusion

    Key Trial Info

    Start Date :

    January 1 2021

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2025

    Estimated Enrollment :

    332 Patients enrolled

    Trial Details

    Trial ID

    NCT04349046

    Start Date

    January 1 2021

    End Date

    December 1 2025

    Last Update

    June 18 2025

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    Hôpital Princesse Paola

    Aye, Belgium, 6900

    2

    CH Alpes Léman

    Contamine-sur-Arve, France, 74130

    3

    CH Annecy Genevois

    Épagny, France, 74370

    4

    Hopital Renee Sabran

    Hyères, France, 83406