Evaluation of the Positioning of the Dynacup Cup "One C" Versus "Standard Dynacup"

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-21

Study Completion Date

2023-03-22

Brief Summary

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The ceramic-ceramic friction pair is widely used today in total hip arthroplasty, including fourth-generation ceramics which show the lowest wear rate. These have considerably reduced the risk of head fracture compared to previous generations; however, the risk of insert rupture persists with rates similar to those of third generation ceramics.

These ceramic fractures require complex revision surgery, which brings complications, exposing patients to the risk of third-body wear and tear related to persistent post-surgical debris. They are frequently due to an incorrect assembly of the ceramic causing intraoperative or early postoperative rupture. To fix this, manufacturers have developed pre-assembled cups in the factory. The Dynacup One C cup developed by Corin® corresponds to the pre-assembled version of the Dynacup cup, making it possible to eliminate the risk of anomaly during intraoperative assembly linked to the human factor and to offer patients with very small cups an adapted ceramic implant. A single study with a small sample compared the two implants (pre-assembled version \[vs\] modular version) clinically, radiologically and functionally without showing any significant difference. The lack of data in the literature comparing these two implants motivated us to conduct a randomized comparative study on a large sample of patients.

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Detailed Description

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Patients eligible for a total hip arthroplasty with a ceramic-ceramic friction couple and scheduled for surgery will be included in this study after information and collection of written consent.

After randomization, a preoperative radiograph with a calibration ball will be taken to plan the prosthesis and identify the characteristics of the operated hip.

An x-ray of the pelvis with a 28 mm ball will be carried out the day after the intervention according to the same preoperative procedures in order to measure the postoperative radiographic parameters.

Conditions

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Hip Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Standard Dynacup

Hip arthroplasty with a standard Dynacup cup

Group Type OTHER

Randomisation Standard Dynacup or Dynacup One C

Intervention Type OTHER

Randomisation

Dynacup One C

Hip arthroplasty with a cup Dynacup One C

Group Type OTHER

Randomisation Standard Dynacup or Dynacup One C

Intervention Type OTHER

Randomisation

Interventions

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Randomisation Standard Dynacup or Dynacup One C

Randomisation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult man and woman \> 18 years old
* Indication for hip arthroplasty with a Dynacup One C or standard Dynacup cup
* Patient informed of the study and signed a consent form

Exclusion Criteria

* Refusal to participate in the study
* Indication of a friction couple other than ceramic-ceramic
* Contraindication or the technical impossibility of implanting an impacted acetabular component
* Pregnant or breastfeeding women.
* Minor patients aged \< 18 years
* Subjects not affiliated to the national health insurance or to an equivalent insurance

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No