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

NCT01684631 | Completed

• 1 other identifier: 27062008
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Arthropathy of Hip

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Harris Hip Score

  pre-operative, 1, 2, 3, 5 years

Other Outcomes (2)

• Cobalt and Chromium serum concentration

  3 to 6 Months, 1, 2, 3, 5 years

• Adverse Event Frequency

  Per-operative, 3 to 6 Months, 1, 2, 3, 5 years

Study Arms (1)

Hip arthroplasty

Patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease or true femoral cervical fracture.

Device: Total Hip arthroplasty

Interventions

Total Hip arthroplasty DEVICE

Hip arthroplasty

Eligibility Criteria

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

Study Population

Patients susceptible to receive a PINNACLE® ULTAMET™ implant

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• DePuy International: lead

Study Sites (6)

Clinique Herbert

Aix-les-Bains, 73100, France

Location

Clinique Bonnefon

Alès, 30104, France

Location

Centre Hospitalier Georges Renon

Niort, 79021, France

Location

Clinique Saint Hilaire

Rouen, 76000, France

Location

Clinique Pasteur

Royan, 17200, France

Location

Clinique Mutualiste Saint Etienne

Saint-Etienne, 42013, France

Location

Related 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. No abstract available.

  PMID: 5783851 BACKGROUND

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Jean-Marie Toupin, MD

  Clinique Saint Hilaire Rouen, France 76000

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 13, 2012
• Study Start: January 1, 2009
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 26, 2016

Record last verified: 2016-09

Locations

FR (6)