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Evaluation of the Positioning of the Dynacup Cup "One C" Versus "Standard Dynacup" (DYNACUP)

Primary Purpose

Hip, Arthropathy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Randomisation Standard Dynacup or Dynacup One C
Sponsored by
Groupe Hospitalier Diaconesses Croix Saint-Simon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hip focused on measuring One-C, Stadard, Dynacup

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Groupe Hospitalier Dianconesses croix saint Simon

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Standard Dynacup

Dynacup One C

Arm Description

Hip arthroplasty with a standard Dynacup cup

Hip arthroplasty with a cup Dynacup One C

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To describe the rate of intraoperative secondary re-impactions of both groups
Note the attempts at re-impactions for sensation of extrusion: after palpation with forceps of the bottom of the acetabulum (bone space - metal back for the standard Dynacups) or of its protruding periphery of the bone (for the pre-assembled versions) . ○ Note the operator's feeling before postoperative control X-ray on the good impaction of the acetabulum: at the bottom, doubtful or extrus.
To describe the rate of intraoperative complications according to the type of implant
Describe the rate of intraoperative complications according to the type of implant: Fracture of ceramics on impaction or assembly Fracture of the bony acetabulum or unplanned acetabular protrusion
To describe the rate of insufficient impaction of the acetabulum in both groups
Describe the rate of insufficient impaction of the acetabulum in the 2 versions Radiographic measurement of the space between the bottom of the prosthetic acetabulum and the bottom of the milled bone acetabulum (Space > 2mm = impaction defect) Radiographic analysis of postoperative front and side views by an independent evaluator
Indentify predictors for insufficient impaction of the acetabular implant
Look for predictive factors of insufficient impaction of the acetabular implant Depending on the type of implant According to the morphology of the arthritic hip: Type of indication and acetabular osteoarthritis: necrosis, upper lateral osteoarthritis, postero-internal osteoarthritis, global osteoarthritis or coxitis Acetabular morphology: osteophytosis, dysplasia, osteocondensation, protrusion, sheathing Femoral morphology: Dorr classification, cervico-diaphyseal angle.

Full Information

First Posted
March 24, 2023
Last Updated
September 19, 2023
Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon
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1. Study Identification

Unique Protocol Identification Number
NCT06053060
Brief Title
Evaluation of the Positioning of the Dynacup Cup "One C" Versus "Standard Dynacup"
Acronym
DYNACUP
Official Title
Evaluation of the Positioning of the Dynacup Cup "One C" Versus Standard Dynacup
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 21, 2021 (Actual)
Primary Completion Date
March 22, 2023 (Actual)
Study Completion Date
March 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip, Arthropathy
Keywords
One-C, Stadard, Dynacup

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Dynacup
Arm Type
Other
Arm Description
Hip arthroplasty with a standard Dynacup cup
Arm Title
Dynacup One C
Arm Type
Other
Arm Description
Hip arthroplasty with a cup Dynacup One C
Intervention Type
Other
Intervention Name(s)
Randomisation Standard Dynacup or Dynacup One C
Intervention Description
Randomisation
Primary Outcome Measure Information:
Title
To Compare the positioning accuracy of the Dynacup One C (pre-assembled version) with that of the standard Dynacup.
Description
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.
Time Frame
Perioperative
Secondary Outcome Measure Information:
Title
To describe the rate of intraoperative secondary re-impactions of both groups
Description
Note the attempts at re-impactions for sensation of extrusion: after palpation with forceps of the bottom of the acetabulum (bone space - metal back for the standard Dynacups) or of its protruding periphery of the bone (for the pre-assembled versions) . ○ Note the operator's feeling before postoperative control X-ray on the good impaction of the acetabulum: at the bottom, doubtful or extrus.
Time Frame
Perioperative
Title
To describe the rate of intraoperative complications according to the type of implant
Description
Describe the rate of intraoperative complications according to the type of implant: Fracture of ceramics on impaction or assembly Fracture of the bony acetabulum or unplanned acetabular protrusion
Time Frame
Perioperative
Title
To describe the rate of insufficient impaction of the acetabulum in both groups
Description
Describe the rate of insufficient impaction of the acetabulum in the 2 versions Radiographic measurement of the space between the bottom of the prosthetic acetabulum and the bottom of the milled bone acetabulum (Space > 2mm = impaction defect) Radiographic analysis of postoperative front and side views by an independent evaluator
Time Frame
Perioperative
Title
Indentify predictors for insufficient impaction of the acetabular implant
Description
Look for predictive factors of insufficient impaction of the acetabular implant Depending on the type of implant According to the morphology of the arthritic hip: Type of indication and acetabular osteoarthritis: necrosis, upper lateral osteoarthritis, postero-internal osteoarthritis, global osteoarthritis or coxitis Acetabular morphology: osteophytosis, dysplasia, osteocondensation, protrusion, sheathing Femoral morphology: Dorr classification, cervico-diaphyseal angle.
Time Frame
Perioperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon MARMOR, MD
Organizational Affiliation
Groupe Hospitalier Diaconesses Croix Saint-Simon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Dianconesses croix saint Simon
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75020
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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