HipDYNACUPNCT06053060
Evaluation of the Positioning of the Dynacup Cup "One C" Versus "Standard Dynacup"
A study testing Randomisation Standard Dynacup or Dynacup One C in people with Hip and Arthropathy, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip, Arthropathy
- What is being tested?
- Randomisation Standard Dynacup or Dynacup One C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2021to 22 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Dianconesses croix saint Simon
Paris, Île-de-France Region, 75020
About this study
Official title: Evaluation of the Positioning of the Dynacup Cup "One C" Versus Standard Dynacup
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.
Read the 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.
- Conditions
- Hip, Arthropathy
- Being tested
- Randomisation Standard Dynacup or Dynacup One C
- Keywords
- One-C, Stadard, Dynacup
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomisation Standard Dynacup or Dynacup One COther
Randomisation
| Study group | Role | What they receive |
|---|---|---|
| Standard Dynacup | Other | Hip arthroplasty with a standard Dynacup cup Receives: Other: Randomisation Standard Dynacup or Dynacup One C |
| Dynacup One C | Other | Hip arthroplasty with a cup Dynacup One C Receives: Other: Randomisation Standard Dynacup or Dynacup One C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperative
Secondary outcomes (4)
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.
Measured: Perioperative
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
Measured: Perioperative
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
Measured: Perioperative
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.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start21 Nov 2021
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SMARMOR, Groupe Hospitalier Diaconesses Croix Saint-Simon
- Investigators
- Simon MARMOR, MD, Principal investigator, Groupe Hospitalier Diaconesses Croix Saint-Simon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053060
- Sponsor's protocol ID
- ID RCB : 2020-A02843-36
- Acronym
- DYNACUP
- Status last verified
- Sep 2023
- First submitted
- 24 Mar 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Positioning of the Dynacup Cup "One C" Versus Standard Dynacup
- ClinicalTrials.gov ID
- NCT06053060
- Acronym / sponsor ID
- DYNACUP / ID RCB : 2020-A02843-36
- Conditions
- Hip, Arthropathy
- Keywords
- One-C, Stadard, Dynacup
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- 21 Nov 2021 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dynacup | Other | Other: Randomisation Standard Dynacup or Dynacup One CHip arthroplasty with a standard Dynacup cup |
| Dynacup One C | Other | Other: Randomisation Standard Dynacup or Dynacup One CHip arthroplasty with a cup Dynacup One C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Randomisation Standard Dynacup or Dynacup One CRandomisation | Other | Dynacup One C, Standard Dynacup |
Primary outcome
To Compare the positioning accuracy of the Dynacup One C (pre-assembled version) with that of the standard Dynacup.
Time frame: Perioperative
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.
4 secondary outcomes
To describe the rate of intraoperative secondary re-impactions of both groups
Time frame: Perioperative
To describe the rate of intraoperative complications according to the type of implant
Time frame: Perioperative
To describe the rate of insufficient impaction of the acetabulum in both groups
Time frame: Perioperative
Indentify predictors for insufficient impaction of the acetabular implant
Time frame: Perioperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon MARMOR, MD principal investigator
Groupe Hospitalier Diaconesses Croix Saint-Simon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomisation Standard Dynacup or Dynacup One C in people with Hip and Arthropathy, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Compare the positioning accuracy of the Dynacup One C (pre-assembled version) with that of the standard Dynacup. (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.