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

NCT02062437 | Completed Results

• 1 other identifier: 1301-T-CERAM-R
• Study Type: observational
• Target: 132
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Arthroplasty; Hip Replacement; Ceramic; Acetabular cup; Femoral stem

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

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

  2-year follow-up visit

Secondary Outcomes (2)

• General Performance: Mobility

  Baseline

• General Performance: Mobility

  2-year Follow-up visit

Other Outcomes (3)

• General Performance: Objective Clinical Score (PMA)

  Baseline

• General Performance: Objective Clinical Score (PMA)

  2-year follow-up visit

• General Performance: Radiological Assessment.

  2-year Follow-up visit

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Able to understand information to participate to the study.

You may not qualify if:

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

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

MeSH Terms

Conditions

Neoplasm Metastasis; Femur Head Necrosis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis

Results Point of Contact

• Title: Nathalie Trétout
• Organization: Tornier SAS

nathalie.tretout@tornier.com

+33 4 76 71 35 00

Study Officials

• Philippe Piriou, MD, Prof.

  Hôpital Universitaire Raymond Poincaré, Garches - France

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 13, 2014
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: January 1, 2014
• Last Updated: May 31, 2017
• Results First Posted: April 28, 2016

Record last verified: 2016-05