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Completed

NCT Number: NCT02525809

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

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.

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novae E®

Device

Sunfit®

Device

Quartz®

Device

Primary outcomes

  1. Measuring the penetration of the femoral head in the polyethylene inserts by radiostereometric analysis (RSA)

    Time frame: change over baseline and 3 years

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: DOUMOB

Important dates

Study start
2010
Primary completion
2012
Study completion
2015
First posted
Aug 17, 2015
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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