Incidence of Dual Mobility Polyethylene Wear in Total Hip Prosthesis. Randomised Study Versus Fixed Insert by Radiostereometric Analysis. (DOUMOB)

The total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. However, observation showed that the dislocation is not a rare complication (2-4%) and the lifetime of the implants is limited due to aseptic loosening.

The evaluation process used in this study will be the extent of penetration of the metal femoral head in the cup and micro mobility metal back by radiostereometric analysis (RSA) whose precision provides early results (2 3 years), long before wear and migration are measurable by conventional radiological means. The main objective will be to compare, 2 years after the intervention, the penetration of the metal femoral head in 3 types of inserts: two dual mobility inserts, one at tripod attachment (Novae E®), the other press fit pure (Sunfit®), and a fixed insert (Quartz®).

This is a randomized controlled trial. 105 patients will be enrolled (35 in each group). Patients will be included in each of the two participating centers (Amiens, Caen). The analysis will be made in RSA D7 + 2, 6 months 1, 12 months 1 24 months 1. An assessment will be made to 3 years if the analysis requires it to 2 years.

Analysis of pictures will be centralized in Caen and performed with specific software after transferring images via a secure network.

Study Overview

• Status: Completed
• Conditions: Total Hip Replacement
• Intervention / Treatment: Device: Novae E®; Device: Sunfit®; Device: Quartz®

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients older men or women 60-75 years
• with a primary or secondary osteoarthritis or osteonecrosis
• having a functional disorder requiring the installation of a total hip prosthesis of primary

Exclusion Criteria:

• patients aged 76 years or more
• protected adults
• resumption of PTH
• cephalic prosthesis recovery or intermediate
• resumption of cupules
• primary or secondary malignant tumor of the hip

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: mobility insert with tripod attachment (Novae E®)	Device: Novae E®
Other: mobility insert with press fit pure (Sunfit®)	Device: Sunfit®
Other: fixed insert (Quartz®).	Device: Quartz®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measuring the penetration of the femoral head in the polyethylene inserts by radiostereometric analysis (RSA)	change over baseline and 3 years

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 13, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimate): August 17, 2015

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 08-114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No