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

Hip Replacement Clinical Trial

— CERAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062437
• Other study ID #: 1301-T-CERAM-R
• Status: Completed
• Phase: N/A
• First received: February 12, 2014
• Last updated: February 12, 2014
• Start date: September 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Tornier, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministère de l'Enseignement supérieur et de la RechercheFrance: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Congenital Dislocations
• Dislocations
• Femur Head Necrosis
• Hip Replacement
• Joint Diseases
• Osteoarthritis
• Primary, Secondary or Post-traumatic Osteoarthrosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tornier, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General performance: objective clinical score (PMA)	Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 6 points (18 is the best score).	2-year Follow-up visit	No
Other	General performance: Radiological assessment.	Radiological assessment is based on : Cup radiological signs.; Stem radiological signs.; Ossifications	2-year Follow-up visit	No
Primary	Adverse events	Surgical incidents.; Post-operative complications.; Failure and revisions analysis.	2-year follow-up visit	Yes
Secondary	General performance: Mobility	Mobility is assessed by the measurement of the degree of amplitude of: extension, flexion, abduction, adduction, external rotation and internal rotation of the hip.	2-year Follow-up visit	No