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

Multicentric Observational Study Evaluating Clinical and Radiological Results of a 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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 132

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	Surgical incidents.; Post-operative complications.; Failure and revisions analysis.	2-year follow-up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Performance: Mobility	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.	Baseline
General Performance: Mobility	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-year Follow-up visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Performance: Objective Clinical Score (PMA)	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).	Baseline
General Performance: Objective Clinical Score (PMA)	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-year follow-up visit
General Performance: Radiological Assessment.	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	2-year Follow-up visit

Collaborators and Investigators

• Sponsor: Stryker Trauma GmbH
• Investigators: Principal Investigator: Philippe Piriou, MD, Prof., Hôpital Universitaire Raymond Poincaré, Garches - France

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: February 12, 2014
• First Posted (Estimate): February 13, 2014

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Arthroplasty; Hip Replacement; Ceramic; Acetabular cup; Femoral stem
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Bone Diseases; Osteonecrosis; Osteoarthritis; Necrosis; Femur Head Necrosis
• Other Study ID Numbers: 1301-T-CERAM-R