Clinical trial NCT06053060: Evaluation of the Positioning of the Dynacup Cup "One C" Versus "Standard Dynacup"
Official title: Evaluation of the Positioning of the Dynacup Cup "One C" Versus Standard Dynacup
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip
Arthropathy
Keywords: One-C
Stadard
Dynacup
Lead sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To Compare the positioning accuracy of the Dynacup One C (pre-assembled version) with that of the standard Dynacup.
timeFrame: Perioperative
Secondary outcomes:
measure: To describe the rate of intraoperative secondary re-impactions of both groups
timeFrame: Perioperative
measure: To describe the rate of intraoperative complications according to the type of implant
timeFrame: Perioperative
measure: To describe the rate of insufficient impaction of the acetabulum in both groups
timeFrame: Perioperative
measure: Indentify predictors for insufficient impaction of the acetabular implant
timeFrame: Perioperative
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Dianconesses croix saint Simon
state: Ile De France
Study officials:
affiliation: Groupe Hospitalier Diaconesses Croix Saint-Simon
name: Simon MARMOR, MD
role: PRINCIPAL_INVESTIGATOR
References: