OsteoarthritisNCT02196818
A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup
An observational study of Osteoarthritis and Arthritis, run by Medacta International SA at 4 sites in United States.
Trial summary
This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Arthritis, Avascular Necrosis
- What is being tested?
- Mpact Acetabular Shell
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2013to Apr 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary total hip arthroplasty
Who may be able to join
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
- Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use).
- Patients must be willing to comply with the pre and post-operative evaluation schedule.
Who cannot join
- Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83702
Vail Orthopedics, P.C.
Denver, Colorado, 80230
Illinois Bone & Joint Institute, LLC
Libertyville, Illinois, 60048
Jordan Valley Medical Center
West Jordan, Utah, 84088
About this study
Official title: A Multi-centre, Prospective Post Marketing Surveillance Study to Assess Mid-term Performance of the Mpact Cup in Subjects Requiring Primary Total Hip Arthroplasty
This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.
- Conditions
- Osteoarthritis, Arthritis, Avascular Necrosis, Fracture of the Femoral Neck or Head, Congenital Hip Dysplasia
- Being tested
- Mpact Acetabular Shell
- Medical subject headings
- Osteoarthritis, Arthritis, Osteonecrosis, Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mpact Acetabular ShellDevice
Total Hip Replacement
| Study group | Role | What they receive |
|---|---|---|
| Mpact Acetabular Shell | Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement. Receives: Device: Mpact Acetabular Shell |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Kaplan-Meier analysis as a measure of implant performance.
Measured: 5 years
Secondary outcomes (2)
The Harris Hip Score.
Measured: pre-op, 3/6 months, 1,2 and 5 years
Radiological analysis as a meausure of safety.
Measured: 3/6 months, 1,2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startMar 2013
- Primary completionApr 2021
- Study completionApr 2022
Why it stopped: Study was closed mainly because the surgeons participating no longer had the infrastructure to support the research and weren't following their subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196818
- Sponsor's protocol ID
- P01.014.08/00
- Status last verified
- Mar 2023
- First submitted
- 7 Jul 2014
- Last updated
- 22 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Prospective Post Marketing Surveillance Study to Assess Mid-term Performance of the Mpact Cup in Subjects Requiring Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02196818
- Acronym / sponsor ID
- P01.014.08/00
- Conditions
- Osteoarthritis, Arthritis, Avascular Necrosis, Fracture of the Femoral Neck or Head, Congenital Hip Dysplasia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was closed mainly because the surgeons participating no longer had the infrastructure to support the research and weren't following their subjects
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- Mar 2013 (actual)
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 22 Jul 2014 (estimated)
- 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.
This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mpact Acetabular Shell | – | Device: Mpact Acetabular ShellMonitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary total hip arthroplasty
Key inclusion criteria (3 listed)
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
- Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use).
- Patients must be willing to comply with the pre and post-operative evaluation schedule.
Key exclusion criteria (1 listed)
- Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this 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 Acetabular ShellTotal Hip Replacement | Device | Mpact Acetabular Shell |
Primary outcome
The Kaplan-Meier analysis as a measure of implant performance.
Time frame: 5 years
2 secondary outcomes
The Harris Hip Score.
Time frame: pre-op, 3/6 months, 1,2 and 5 years
Radiological analysis as a meausure of safety.
Time frame: 3/6 months, 1,2 and 5 years
Results and safety
The study was stopped early (reason given: Study was closed mainly because the surgeons participating no longer had the infrastructure to support the research and weren't following their subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Arthritis, run by Medacta International SA at 4 sites in United States.
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 1 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: stopped early, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 was stopped early (reason given: Study was closed mainly because the surgeons participating no longer had the infrastructure to support the research and weren't following their subjects). Results are not available in the source record.
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?
The Kaplan-Meier analysis as a measure of implant performance. (time frame: 5 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 22 Mar 2023.