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

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ClinicalTrials.gov Identifier: NCT02062437
Recruitment Status : Completed
First Posted : February 13, 2014
Results First Posted : April 28, 2016
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Tornier, Inc.

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.

Condition or disease
Hip Replacement Primary, Secondary or Post-traumatic Osteoarthrosis Femur Head Necrosis Congenital Dislocations

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Study Type : Observational
Actual Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicentric Observational Study Evaluating Clinical and Radiological Results of a Total Hip Arthroplasty Using a Ceramic Friction Pair
Study Start Date : September 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Group/Cohort
Total hip replacement using a ceramic friction pair
Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup



Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 2-year follow-up visit ]
    • Surgical incidents.
    • Post-operative complications.
    • Failure and revisions analysis.


Secondary Outcome Measures :
  1. 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.


  2. 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.



Other Outcome Measures:
  1. General Performance: Objective Clinical Score (PMA) [ Time Frame: Baseline ]
    Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 0 to 6 points (0 is the worst possible score and 18 is the best possible PMA score).

  2. General Performance: Objective Clinical Score (PMA) [ Time Frame: 2-year follow-up visit ]
    Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 0 to 6 points (0 is the worst possible score and 18 is the best possible PMA score).

  3. General Performance: Radiological Assessment. [ Time Frame: 2-year Follow-up visit ]

    Radiological assessment is based on :

    • Cup radiological signs of osteolysis or radiolucencies.
    • Stem radiological signs of osteolysis or radiolucencies.
    • Ossifications according to Brooker classification from class I: Ossification around the hip joint. to class IV: shows apparent bone ankylosis of the hip. (i.e Class 0 = no ossification)
    • Other Radiological signs



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cohort of European patients with a primary total hip replacement using a ceramic friction pair including Meije Duo® stem associated with a Dynacup® cup.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062437


Sponsors and Collaborators
Tornier, Inc.
Investigators
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Principal Investigator: Philippe Piriou, MD, Prof. Hôpital Universitaire Raymond Poincaré, Garches - France
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Responsible Party: Tornier, Inc.
ClinicalTrials.gov Identifier: NCT02062437    
Other Study ID Numbers: 1301-T-CERAM-R
First Posted: February 13, 2014    Key Record Dates
Results First Posted: April 28, 2016
Last Update Posted: May 31, 2017
Last Verified: May 2016
Keywords provided by Tornier, Inc.:
Arthroplasty
Hip Replacement
Ceramic
Acetabular cup
Femoral stem
Additional relevant MeSH terms:
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Osteoarthritis
Femur Head Necrosis
Necrosis
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases
Osteonecrosis
Bone Diseases