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Status:

TERMINATED

NANOS Neck Preserving Hip Stem

Lead Sponsor:

Smith & Nephew Orthopaedics AG

Conditions:

Primary Osteoarthritis

Secondary Osteoarthritis

Eligibility:

All Genders

18-65 years

Brief Summary

The objective of this study is to determine the long-term safety and effectiveness of the NANOS neck preserving stem in terms of radiographic and clinical performance as well as short-, mid- and long-...

Detailed Description

The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the NANOS neck preserving hip stem. Effectiveness Measures: * Evaluation...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Inclusion criteria:
  • Patient requires Primary total hip replacement (THR) to the affected side, unilateral or bilateral. Bilateral only if \>3 months after the first THR
  • Patient agreed to participate in the MCO study by signing the Informed Consent form.
  • Age of patient at date of surgery 18 to 65 years
  • Patient is likely to comply with study follow-up requirements
  • Exclusion criteria:
  • Previously failed endoprosthesis and /or THR components in relevant hip
  • Patient has proven osteoporosis
  • Pronounced coxa valga with a femoral neck angle \> 145º
  • Pronounced coxa vara with a femoral neck angle \< 125º
  • History of infection in the affected joint; systemic infections
  • Grossly insufficient femoral or acetabular bone stock in the involved hip where a revision cup is indicated
  • Spinal disease with neurologic movement disorders
  • Alcoholism or addictive disorders
  • ASA score is 3 or 4
  • Body mass index (BMI) \> 30
  • Patient is pregnant or being pregnant during follow up intervals
  • Patients understanding of the language is insufficient for understanding the Patient Information and Consent

Exclusion

    Key Trial Info

    Start Date :

    January 21 2010

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2023

    Estimated Enrollment :

    130 Patients enrolled

    Trial Details

    Trial ID

    NCT04036279

    Start Date

    January 21 2010

    End Date

    March 1 2023

    Last Update

    June 7 2023

    Active Locations (3)

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

    Page 1 of 1 (3 locations)

    1

    University Marburg, Orthopedics and Rheumatology

    Marburg, Germany, 35043

    2

    Medisch Centrum Alkmaar

    Alkmaar, Netherlands

    3

    Samodzielny Publiczny Wojewodzki Spital

    Piekary Śląskie, Poland, 41-940