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

NCT06053060 | Completed

• 1 other identifier: ID RCB : 2020-A02843-36
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip; Arthropathy

Keywords

One-C; Stadard; Dynacup

Outcome Measures

Primary Outcomes (1)

• To Compare the positioning accuracy of the Dynacup One C (pre-assembled version) with that of the standard Dynacup.

  Radiographic measurement of the position of the center of rotation of the final implant, its inclination and its anteversion, compared to the positioning planned before the intervention for the 2 types of implants.

  Perioperative

Secondary Outcomes (4)

• To describe the rate of intraoperative secondary re-impactions of both groups

  Perioperative

• To describe the rate of intraoperative complications according to the type of implant

  Perioperative

• To describe the rate of insufficient impaction of the acetabulum in both groups

  Perioperative

• Indentify predictors for insufficient impaction of the acetabular implant

  Perioperative

Study Arms (2)

Standard Dynacup

OTHER

Hip arthroplasty with a standard Dynacup cup

Other: Randomisation Standard Dynacup or Dynacup One C

Dynacup One C

OTHER

Hip arthroplasty with a cup Dynacup One C

Other: Randomisation Standard Dynacup or Dynacup One C

Interventions

Randomisation Standard Dynacup or Dynacup One C OTHER

Randomisation

Dynacup One C; Standard Dynacup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

Study Sites (1)

Groupe Hospitalier Dianconesses croix saint Simon

Paris, Île-de-France Region, 75020, France

Location

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Simon MARMOR, MD

  Groupe Hospitalier Diaconesses Croix Saint-Simon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: September 25, 2023
• Study Start: November 21, 2021
• Primary Completion: March 22, 2023
• Study Completion: March 22, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)