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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03680443
Other study ID # PI2017_843_0041
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2013
Est. completion date April 26, 2017

Study information

Verified date September 2018
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Total hip arthroplasty (THA) requires bone reconstruction in case of severe acetabular injury, with risk of dislocation, especially postoperatively. Dual-mobility cups have proved effective in preventing dislocation in THA revision for instability, but their behavior when cemented in a metal reinforcement has been little studied.

The present study assessed results for a dual-mobility cup cemented in a metal reinforcement, in terms of aseptic loosening and postoperative instability.

A single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up.


Description:

Total hip arthroplasty (THA) requires bone reconstruction in case of severe acetabular injury, with risk of dislocation, especially postoperatively. Dual-mobility cups have proved effective in preventing dislocation in THA revision for instability, but their behavior when cemented in a metal reinforcement has been little studied.

The present study assessed results for a dual-mobility cup cemented in a metal reinforcement, in terms of aseptic loosening and postoperative instability.

A single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up. Failure due to aseptic loosening or instability and implant survival at last follow-up were analyzed.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date April 26, 2017
Est. primary completion date April 26, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years to 94 Years
Eligibility Inclusion Criteria:

- patients between 19 and 84 years

- patients receiving such an assembly in THA revision

Exclusion Criteria:

- <19years

- > 94 years

Study Design


Related Conditions & MeSH terms


Intervention

Other:
assembly in THA revision
A single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up. Failure due to aseptic loosening or instability and implant survival at last follow-up were analyzed.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Outcome

Type Measure Description Time frame Safety issue
Primary dual-mobility cup cemented (effectiveness in terms of aseptic loosening) The objective of the present study is to evaluate the most effective type of assembly , dual-mobility cup cemented in a metal reinforcement, in terms of aseptic loosening in the prevention of dislocation during the revision of the total hip arthroplasty (THA) 5 years
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