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Completed

NCT Number: NCT02062437

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

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.

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Key information

Conditions

Hip Replacement Bone Diseases Congenital Dislocations Femur Head Necrosis Musculoskeletal Diseases Necrosis Neoplasm Metastasis Neoplasms Neoplastic Processes Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Primary, Secondary or Post-traumatic Osteoarthrosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 2-year follow-up visit

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

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Stryker Trauma and Extremities

Industry

Registry information

Official study title

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

Acronym: CERAM

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Feb 13, 2014
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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