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

Completed

• Conditions: Primary, Secondary or Post-traumatic Osteoarthrosis; Femur Head Necrosis; Hip Replacement; Congenital Dislocations

• Registration Number: NCT02062437
• Lead Sponsor: Stryker Trauma and Extremities

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 Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2013-11
• Study Completion: 2014-01
• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-13
• Results First Submitted: 2015-12-09
• Results First Submitted QC: 2016-03-25
• Results First Posted: 2016-04-28
• Status Verified: 2016-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Male or female patient implanted with a primary total hip replacement using a ceramic friction pair including Meije Duo® stem associated with a Dynacup® cup.
• Aged of more than 18 years at the time of the surgery.
• Patient with a follow-up of at least 2 years after surgery based on a consecutive and exhaustive series of patients operated within the inclusion period.
• Able to understand information to participate to the study.

Exclusion Criteria

• Patient having a tumoral pathology.
• Patient having expressed opposition to the study participation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	2-year follow-up visit	* Surgical incidents.; * Post-operative complications.; * Failure and revisions analysis.

Secondary Outcome Measures

Name	Time	Method
General Performance: Mobility	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.