Total Hip ArthroplastyNCT04801680
Mpact 3D Metal Cup PMS
An observational study of Total Hip Arthroplasty, run by Medacta International SA at 1 site in Italy.
Trial summary
Cementless fixation, with or without screw augmentation, has evolved during the past few decades as the preferred method for acetabular reconstruction. Although major improvements have been recorded with regard to clinical outcomes and survivorship, acetabular component loosening remains among the most common causes… 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 cup
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 7 Nov 2019to 7 Dec 2032
- 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: No sample size calculation has been performed; the number of patients has been defined according to the ODEP panel directive (Orthopaedic Data Evaluation Panel), for a long term post-marketing observational study. The number of patients is in line with long term observational study and considered sufficient to evaluate 10 years survival rate of the cup.
Who may be able to join
- Those suffering from hip primary arthrosis, post-traumatic arthrosis, hip dysplasia or avascular necrosis of femoral head, rheumatic arthrosis
- Those aged between 18 and 75 years old at the surgery time
- those suitable to undergo to a primary total hip arthroplasty for whom the Mpact 3D Metal cup will be implanted (according to the label indication/contraindications)
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to patient's surgery
Who cannot join
- Those with acute or chronic infection
- Those whose mental conditions may compromise their ability to provide informed consent to study participation, ability to complete questionnaires or complete 10-year follow-ups.
- Those suffered by severe deformation, at the discretion of surgeon
- Those suffered by osteoporosis
- Those with metabolic disorders that may involve bone metabolism for which cementless implants are contraindicated
- Those suffered by muscular atrophy or neuromuscular disease
Show all 9Show fewer
- Those allergic to medical device material previewed for the surgery
- Those unable to give their consent to participate in the study or who do not want to participate
- Those whose functional recovery is compromised by
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRRCCS Istituto Ortopedico Galeazzi
Milan, MI, 20161
Rocco D'Appolito, +39 02 662141, roccodapolito@hotmail.it
About this study
Official title: A Multicentric, Prospective Clinical Survey on Long Term Performance of an Acetabular Component in Primary Total Hip Arthroplasty
Cementless fixation, with or without screw augmentation, has evolved during the past few decades as the preferred method for acetabular reconstruction. Although major improvements have been recorded with regard to clinical outcomes and survivorship, acetabular component loosening remains among the most common causes of failure and revision. Patient age, poor bone quality and conditions, such as osteonecrosis and dysplasia, have been observed to influence negatively long-term clinical results.
Initial stability is fundamental for survivorship of cementless cups. Prerequisites to achieve durable cementless cup fixation are close contact with viable native bone, primary mechanical stability and secondary bone integration. Press-fit techniques provide optimal conditions for bone ingrowth and fixation but research focused on cup material in order to improve primary stability. Pore size, bone-implant apposition, and material properties all influence bone ingrowth and long-term stability.
Read more
Biological ingrowth surfaces have become a standard prosthetic element in reconstructive hip surgery. A material's properties, three-dimensional architecture, and surface texture all play integral parts in its biological performance. Trabecular metal is an important new biomaterial that has been introduced to enhance the potential of biological ingrowth as well as provide a structural scaffold in cases of severe bone deficit. The continuity between the porous and solid parts has been specifically developed to overcome the limitations of the traditional porous coatings. In fact, the absence of an interface between the trabecular structure and the bulk material provides greater structural solidity and thus higher resistance to detachment and corrosion. Initial clinical applications have focused on bone restoration in tumor and salvage cases and in primary and revision reconstructive cases where the increased biological fixation would be of clinical benefit. However the bone ingrowth potential and mechanical integrity of this material offer exciting options for orthopedic reconstructive surgeons such as difficult THA cases, such as patients with high demands, subjects affected by severe hip conditions (i.e. osteonecrosis, dysplasia) or with extremely poor bone quality. Medacta Mpact 3D Metal cup, is an acetabular cup realized using the EBM (Electron Beam Melting) powder technology; this production method offers a high friction and scratch-fit feel for the initial stability, without the need of any additional coating. Moreover the 3D Metal structure creates a favorable environment for bone thus providing secondary fixation.
The aim of this study is to evaluate the long term clinical and radiological performance of MPact 3D Metal acetabular component.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Mpact 3D metal cup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mpact 3D metal cupDevice
Subjects, among those whose clinical condition makes them eligible for a primary total hip arthroplasty, will be invited to participate to the study during preoperative visit. They'll receive the Mpact 3D metal cup device
| Study group | Role | What they receive |
|---|---|---|
| Mpact 3d metal | Subjects, among those whose clinical condition makes them eligible for a primary total hip arthroplasty, will be invited to participate to the study during preoperative visit. The Receives: Device: Mpact 3D metal cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
long term performance
Device survival will be assessed by Kaplan Meier curve
Measured: 10 years
Secondary outcomes (4)
Clinical performance
Harris Hip Score collected during preoperative and follow-up visits. Harris Hip score scale correspond to 0-100 points. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Measured: 3 months, 1, 5, 7 and 10 years after surgery
Radiological performance
standard x-ray exam performed preoperatively and postoperatively before discharge from hospital and during follow-up visits
Measured: 3 months, 1, 5, 7 and 10 years after surgery
Hip physical function after surgery
HOOS-PS score collected during preoperative visit and follow-up visit. HOOS PS scale correspond to 100 (no difficulty) to 0 (extreme difficulty) scale.
Measured: 3 months and 1, 5, 7 and 10 years after surgery
Rate of complications
collection of adverse events
Measured: up to 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start7 Nov 2019
- Primary completion7 Dec 2032 (estimated)
- Study completion7 Dec 2032 (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.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801680
- Sponsor's protocol ID
- P01.023.01
- Status last verified
- Apr 2024
- First submitted
- 16 Dec 2020
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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
- A Multicentric, Prospective Clinical Survey on Long Term Performance of an Acetabular Component in Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04801680
- Acronym / sponsor ID
- P01.023.01
- Conditions
- Total Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 7 Dec 2032 (estimated)
- Study completion
- 7 Dec 2032 (estimated)
- First posted
- 17 Mar 2021 (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.
Cementless fixation, with or without screw augmentation, has evolved during the past few decades as the preferred method for acetabular reconstruction. Although major improvements have been recorded with regard to clinical outcomes and survivorship, acetabular component loosening remains among the most common causes of failure and revision. Patient age, poor bone quality and conditions, such as osteonecrosis and dysplasia, have been observed to influence negatively long-term clinical results.
Initial stability is fundamental for survivorship of cementless cups. Prerequisites to achieve durable cementless cup fixation are close contact with viable native bone, primary mechanical stability and secondary bone integration. Press-fit techniques provide optimal conditions for bone ingrowth and fixation but research focused on cup material in order to improve primary stability. Pore size, bone-implant apposition, and material properties all influence bone ingrowth and long-term stability.
Biological ingrowth surfaces have become a standard prosthetic element in reconstructive hip surgery. A material's properties, three-dimensional architecture, and surface texture all play integral parts in its biological performance. Trabecular metal is an important new biomaterial that has been introduced to enhance the potential of biological ingrowth as well as provide a structural scaffold in cases of severe bone deficit. The continuity between the porous and solid parts has been specifically developed to overcome the limitations of the traditional porous coatings. In fact, the absence of an interface between the trabecular structure and the bulk material provides greater structural solidity and thus higher resistance to detachment and corrosion. Initial clinical applications have focused on bone restoration in tumor and salvage cases and in primary and revision reconstructive cases where the increased biological fixation would be of clinical benefit. However the bone ingrowth potential and mechanical integrity of this material offer exciting options for orthopedic reconstructive surgeons such as difficult THA cases, such as patients with high demands, subjects affected by severe hip conditions (i.e. osteonecrosis, dysplasia) or with extremely poor bone quality. Medacta Mpact 3D Metal cup, is an acetabular cup realized using the EBM (Electron Beam Melting) powder technology; this production method offers a high friction and scratch-fit feel for the initial stability, without the need of any additional coating. Moreover the 3D Metal structure creates a favorable environment for bone thus providing secondary fixation.
The aim of this study is to evaluate the long term clinical and radiological performance of MPact 3D Metal acetabular component.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mpact 3d metal | – | Device: Mpact 3D metal cupSubjects, among those whose clinical condition makes them eligible for a primary total hip arthroplasty, will be invited to participate to the study during preoperative visit. The |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- No sample size calculation has been performed; the number of patients has been defined according to the ODEP panel directive (Orthopaedic Data Evaluation Panel), for a long term post-marketing observational study. The number of patients is in line with long term observational study and considered sufficient to evaluate 10 years survival rate of the cup.
Key inclusion criteria (4 listed)
- Those suffering from hip primary arthrosis, post-traumatic arthrosis, hip dysplasia or avascular necrosis of femoral head, rheumatic arthrosis
- Those aged between 18 and 75 years old at the surgery time
- those suitable to undergo to a primary total hip arthroplasty for whom the Mpact 3D Metal cup will be implanted (according to the label indication/contraindications)
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to patient's surgery
Key exclusion criteria (9 listed)
- Those with acute or chronic infection
- Those whose mental conditions may compromise their ability to provide informed consent to study participation, ability to complete questionnaires or complete 10-year follow-ups.
- Those suffered by severe deformation, at the discretion of surgeon
- Those suffered by osteoporosis
- Those with metabolic disorders that may involve bone metabolism for which cementless implants are contraindicated
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 cupSubjects, among those whose clinical condition makes them eligible for a primary total hip arthroplasty, will be invited to participate to the study during preoperative visit. They'll receive the Mpact 3D metal cup device | Device | Mpact 3d metal |
Primary outcome
long term performance
Time frame: 10 years
Device survival will be assessed by Kaplan Meier curve
4 secondary outcomes
Clinical performance
Time frame: 3 months, 1, 5, 7 and 10 years after surgery
Radiological performance
Time frame: 3 months, 1, 5, 7 and 10 years after surgery
Hip physical function after surgery
Time frame: 3 months and 1, 5, 7 and 10 years after surgery
Rate of complications
Time frame: up to 10 years after surgery
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.
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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.
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 Italy.
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 4 inclusion and 9 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 Italy. 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 Luigi Zagra, Dr (00390266214834, luigi.zagra@fastwebnet.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
long term performance (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.