Total Hip ArthroplastyNCT05785364
A Post Market Surveillance Study About the MONOCER Cup
An observational study of Total Hip Arthroplasty, run by Medacta International SA at 1 site in Switzerland.
Trial summary
Over the years, the use of large diameter femoral heads has become increasingly common in orthopaedics due to the decreased risk of dislocation due to increased jumping distance and range of motion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Mpact 3D metal MONOCER cup
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Jan 2022to 1 Feb 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients listed for a Total Hip Arthroplasty (THA) with Mpact 3D Metal MONOCER cup, meeting all inclusion/exclusion criteria, at the research site, will be proposed to take part to the current study during the preoperative visit. The investigator will explain to each participant the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits and any discomfort it may entail
Who may be able to join
- Patients undergoing total hip arthroplasty who will receive the Mpact 3D Metal MonoCER acetabular component according to the instructions for use
- Patients who have signed the informed consent to participate in the study
Who cannot join
- Minor patients, patients over 75 years of age at the time of primary surgery;
- Any patient who is unable or unwilling to give informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Hirslanden, Clinique la Colline
Geneva, 1205
Placido Bartolone, Dr, +41227022585, placido.bartolone@hirslanden.ch
About this study
Official title: Monocer Cup: Open, Prospective, Multicentric, Non Randomised Observational Study
Over the years, the use of large diameter femoral heads has become increasingly common in orthopaedics due to the decreased risk of dislocation due to increased jumping distance and range of motion. The history of total hip arthroplasty does not favour large diameter heads, especially as conventional polyethylene has a high risk of wear. The development of hard-on-hard bearings (CoC) with a second generation ceramic material and the introduction of cross-linked PE have led to the reintroduction of this concept. The Mpact 3D Metal MonoCER cup was developed to offer the advantages of accommodating large diameter heads with an external metal cup with a pre-assembled system that avoids the surgical step of insert-cotile coupling.
Read the detailed description
All patients candidated to receive a total hip arthroplasty under 75 years old, who will receive a Mpact 3D Metal cup will be proposed to take part to the study. They will receive the same treatment in case they will not partecipate; the study is an observational study according to standard practice. The study aim to assess the long term peformance of the cup at 10 years after surgery. The patients will be visited at 6 months, 1, 5 and 10 years after surgery.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Mpact 3D metal MONOCER cup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mpact 3D metal MONOCER cupDevice
adult patients requiring a total hip arthroplasty under 75 years old, will receive the Mpact 3D metal cup, as acetabular sheel device implanted
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of implant survivorship using Kaplan Meier curve
a Kaplan Meir survival curve will be calcuated
Measured: 10 years
Secondary outcomes (3)
Assessment of Device stability throught a radiological exam
standard x-ray examination will be peformed during the visits
Measured: 6 months, 1 year, 5 and 10 years
Assessment of the clinical outcome following total hip replacement using the Harris Hip score
HHS score will be completed
Measured: 6 months, 1 year, 5 and 10 years
Device Safety assessed through adverse event collection
number of adverse event occurred
Measured: up to 10 yrs follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start25 Jan 2022
- Primary completion1 Feb 2050 (estimated)
- Study completion1 Feb 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Medacta International SAThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Placido Bartolone, Dr, Principal investigator, Hirslanden, Clinique la Colline 76A Av. de la Roseraie 1205 Genève
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785364
- Sponsor's protocol ID
- P01.026.02
- Status last verified
- Apr 2024
- First submitted
- 13 Mar 2023
- Last updated
- 1 May 2024
- Results posted
- 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 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocer Cup: Open, Prospective, Multicentric, Non Randomised Observational Study
- ClinicalTrials.gov ID
- NCT05785364
- Acronym / sponsor ID
- P01.026.02
- Conditions
- Total Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 1 Feb 2050 (estimated)
- Study completion
- 1 Feb 2050 (estimated)
- First posted
- 27 Mar 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.
Over the years, the use of large diameter femoral heads has become increasingly common in orthopaedics due to the decreased risk of dislocation due to increased jumping distance and range of motion. The history of total hip arthroplasty does not favour large diameter heads, especially as conventional polyethylene has a high risk of wear. The development of hard-on-hard bearings (CoC) with a second generation ceramic material and the introduction of cross-linked PE have led to the reintroduction of this concept. The Mpact 3D Metal MonoCER cup was developed to offer the advantages of accommodating large diameter heads with an external metal cup with a pre-assembled system that avoids the surgical step of insert-cotile coupling.
Detailed description
All patients candidated to receive a total hip arthroplasty under 75 years old, who will receive a Mpact 3D Metal cup will be proposed to take part to the study. They will receive the same treatment in case they will not partecipate; the study is an observational study according to standard practice. The study aim to assess the long term peformance of the cup at 10 years after surgery. The patients will be visited at 6 months, 1, 5 and 10 years after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients listed for a Total Hip Arthroplasty (THA) with Mpact 3D Metal MONOCER cup, meeting all inclusion/exclusion criteria, at the research site, will be proposed to take part to the current study during the preoperative visit. The investigator will explain to each participant the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits and any discomfort it may entail
Key inclusion criteria (2 listed)
- Patients undergoing total hip arthroplasty who will receive the Mpact 3D Metal MonoCER acetabular component according to the instructions for use
- Patients who have signed the informed consent to participate in the study
Key exclusion criteria (2 listed)
- Minor patients, patients over 75 years of age at the time of primary surgery;
- Any patient who is unable or unwilling to give informed consent to participate in the study.
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 |
|---|---|---|
| Mpact 3D metal MONOCER cupadult patients requiring a total hip arthroplasty under 75 years old, will receive the Mpact 3D metal cup, as acetabular sheel device implanted | Device | – |
Primary outcome
Assessment of implant survivorship using Kaplan Meier curve
Time frame: 10 years
a Kaplan Meir survival curve will be calcuated
3 secondary outcomes
Assessment of Device stability throught a radiological exam
Time frame: 6 months, 1 year, 5 and 10 years
Assessment of the clinical outcome following total hip replacement using the Harris Hip score
Time frame: 6 months, 1 year, 5 and 10 years
Device Safety assessed through adverse event collection
Time frame: up to 10 yrs follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
Related trials for Total Hip Arthroplasty
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
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Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
Not yet recruiting
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Postoperative Pain, Hip Arthroplasty, Total
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial
Anaesthetic Requirements During Total Hip Arthroplasty
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.
Placido Bartolone, Dr principal investigator
Hirslanden, Clinique la Colline 76A Av. de la Roseraie 1205 Genève
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty, run by Medacta International SA at 1 site in Switzerland.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 May 2024. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisa Bonacina, PhD (+41 91 696 60 60, bonacina@medacta.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of implant survivorship using Kaplan Meier curve (time frame: 10 years). 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 1 May 2024.