Clinical Trial: Clinical and Radiological Results of Total Hip Arthroplasty Using a Ceramic Friction Pair

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Multicentric Observational Study Evaluating Clinical and Radiological Results of a Total Hip Arthroplasty Using a Ceramic Friction Pair

Brief Summary: The aim of this study is to assess safety and general performance of total hip arthroplasty, composed of a Meije Duo® femoral stem associated with a Dynacup® cup, and using the friction pair Biolox® Delta Ceramic.

Detailed Summary:
Sponsor: Tornier, Inc.

Current Primary Outcome: Number of Participants With Adverse Events [ Time Frame: 2-year follow-up visit ]

  • Surgical incidents.
  • Post-operative complications.
  • Failure and revisions analysis.


Original Primary Outcome: Adverse events [ Time Frame: 2-year follow-up visit ]

  • Surgical incidents.
  • Post-operative complications.
  • Failure and revisions analysis.


Current Secondary Outcome:

  • General Performance: Mobility [ Time Frame: Baseline ]

    Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°).

    Normal values (usually observed range of motions) are:

    extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°).

    Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion.

  • General Performance: Mobility [ Time Frame: 2-year Follow-up visit ]

    Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°).

    Normal values (usually observed range of motions) are:

    extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°).

    Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion.



Original Secondary Outcome: General Performance: Mobility [ Time Frame: 2-year Follow-up visit ]

Mobility is assessed by the measurement of the degree of amplitude of: extension, flexion, abduction, adduction, external rotation and internal rotation of the hip.


Information By: Tornier, Inc.

Dates:
Date Received: February 12, 2014
Date Started: September 2013
Date Completion:
Last Updated: May 26, 2016
Last Verified: May 2016