Evaluation of Implant Survival in Patients With a Pinnacle Ultamet Device in Conventional Total Hip Joint Replacement

Arthropathy of Hip Clinical Trial

Official title:

Prospective, Multicentric, Observational Cohort Study for the Evaluation of Implant Survival in Patients With a Metal-on-Metal Pinnacle(R) Ultamet(TM) Device in Conventional Total Hip Joint Replacement.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684631
• Other study ID #: 27062008
• Status: Completed
• Phase: N/A
• First received: September 11, 2012
• Last updated: September 23, 2016
• Start date: January 2009
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministère de l'Enseignement supérieur et de la Recherche
• Study type: Observational

Clinical Trial Summary

The objective is to evaluate the implant survival rate for patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease and true femoral cervical fracture.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients susceptible to receive a PINNACLE® ULTAMET™ implant as per routine practice

Exclusion Criteria:

• Patient refusal to participate to the data collection

• Pregnant woman

• Patients age is less than 18 years old

• The planned intervention is a revision of a previous intervention on the studied hip joint

• Previous metal implant, except for pure titanium or titanium alloys

• Exposure to cobalt and chromium that could influence serum metal ions levels

• Planned bilateral intervention

• Patient residing outside France

• Patient not implanted with a Pinnacle(R) ULTAMET(TM)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthropathy of Hip
• Joint Diseases

Intervention

Device:
• Total Hip arthroplasty

Locations

Country	Name	City	State
France	Clinique Herbert	Aix-les-Bains
France	Clinique Bonnefon	Ales
France	Centre Hospitalier Georges Renon	Niort
France	Clinique Saint Hilaire	Rouen
France	Clinique Pasteur	Royan
France	Clinique Mutualiste Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Country where clinical trial is conducted

France, 

References & Publications (1)

Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cobalt and Chromium serum concentration	Descriptive analysis of patient serum concentration of Cobalt and Chromium	3 to 6 Months, 1, 2, 3, 5 years	No
Other	Adverse Event Frequency	Descriptive Analysis of Adverse Event Frequency for the duration of the study.	Per-operative, 3 to 6 Months, 1, 2, 3, 5 years	No
Primary	Implant Survival Rate	Implant Survival Rate as the duration of PINNACLE® ULTAMET™ implantation for the follow-up duration, free of revision surgery, whatever the cause.	up to 5 years	No
Secondary	Harris Hip Score	Measure of hip function using the Harris Hip Score	pre-operative, 1, 2, 3, 5 years	No