Hip OsteoarthritisNCT03897595
Assess the Mid-term Performance of the Mpact Cup in Subjects Requiring Total Hip Arthroplasty
An observational study of Hip Osteoarthritis, run by Medacta USA at 5 sites in United States.
Trial summary
Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- MPact Cup
- Type of treatment
- Medical device
- How many people
- 187 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2012to 30 Mar 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
- Healthy volunteers accepted
- Child, Adult, Older adult
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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Saint Alphonsus Medical Group
Boise, Idaho, 83706
Illinois Bone and Joint Institute
Libertyville, Illinois, 60048
McBride Orthopedic Hospital
Oklahoma City, Oklahoma, 73103
Denver Vail Orthopedics
Parker, Colorado, 80134
Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence
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
Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.
- Conditions
- Hip Osteoarthritis
- Being tested
- MPact Cup
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPact CupDevice
Quadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head
| Study group | Role | What they receive |
|---|---|---|
| Mpact cup | Quadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head Receives: Device: MPact Cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Harris Hip Scores (HHS)
Assessment of improvement of clinical outcomes following total hip replacement surgery using the Harris Hip Scores
Measured: Pre-operative, 3 or 6 months, 1 year, 2 year and 5 year
Change from baseline of implant survivorship
Assessment of bone fracture, implant fracture, neck reabsorption
Measured: Post-operative 3 or 6 months, 1 year, 2 year, and 5 year
Change in baseline of Complications
Assessment of Adverse events and serious adverse events
Measured: Day of surgery, post-operative 3 or 6 months, 1 year, 2 year, and 5 year.
Change in baseline fixation and wear
Radiographic analysis by measuring Radio Lucent Lines
Measured: Post-operative 3 or 6 months, 1 year, 2 year and 5 year
Change in baseline fixation
Radiographic analysis by measuring implant fixation in millimeters
Measured: Post-operative 3 or 6 months, 1 year, 2 year and 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study startOct 2012
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip 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
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897595
- Sponsor's protocol ID
- P01.014.08/01
- Status last verified
- Jun 2023
- First submitted
- 11 Mar 2019
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 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
- NCT03897595
- Acronym / sponsor ID
- P01.014.08/01
- Conditions
- Hip Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Medacta USAIndustry (pharma, biotech, devices)
- Study start
- Oct 2012 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 1 Apr 2019 (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.
Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mpact cup | – | Device: MPact CupQuadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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.
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 CupQuadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head | Device | Mpact cup |
Primary outcome
Change from baseline Harris Hip Scores (HHS)
Time frame: Pre-operative, 3 or 6 months, 1 year, 2 year and 5 year
Assessment of improvement of clinical outcomes following total hip replacement surgery using the Harris Hip Scores
Change from baseline of implant survivorship
Time frame: Post-operative 3 or 6 months, 1 year, 2 year, and 5 year
Assessment of bone fracture, implant fracture, neck reabsorption
Change in baseline of Complications
Time frame: Day of surgery, post-operative 3 or 6 months, 1 year, 2 year, and 5 year.
Assessment of Adverse events and serious adverse events
Change in baseline fixation and wear
Time frame: Post-operative 3 or 6 months, 1 year, 2 year and 5 year
Radiographic analysis by measuring Radio Lucent Lines
Change in baseline fixation
Time frame: Post-operative 3 or 6 months, 1 year, 2 year and 5 year
Radiographic analysis by measuring implant fixation in millimeters
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 18 Jun 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Osteoarthritis, run by Medacta USA at 5 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: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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?
Change from baseline Harris Hip Scores (HHS) (time frame: Pre-operative, 3 or 6 months, 1 year, 2 year and 5 year). The study lists 5 primary outcomes in all. 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 18 Jun 2023.