Total Hip ArthroplastyNCT02414542
Minima Clinical Study
An observational study of Total Hip Arthroplasty, run by Limacorporate S.p.a at 1 site in Italy.
Trial summary
Post-marketing clinical study,international, multi-centre, prospective, observational. The investigation will be carried out in 2 sites in Europe for a maximum total number of 160 patients.The aim of this study is to assess clinical, radiographic and subjective outcomes after hip arthroplasty with a cementless… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- MINIMA stem
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2013to Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected for recruitment into the study from the general diagnosis population of patients requiring a primary hip arthroplasty, due to symptomatic painful degenerative joint diseases (NDJD). Patients requiring a revision of a previous failed stem cannot be enrolled into the clinical evaluation.
Who may be able to join
- Both genders
- Age ≥ 18 years old
- Life expectancy over 5 years
- Any race
- Ambulatory patients
- Painful primary coxarthrosis
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- Painful secondary coxarthrosis
- Avascular necrosis
- Willingness to comply with rehabilitation and study evaluation and ability to return for follow-up visits
- Signed study-specific Informed Consent Form
Who cannot join
- Body mass index over 28 kg/m2 for the modular version
- Requiring revision of previous standard femoral stem
- Symptomatic OA of the knees, spine, ankles or contralateral hip, if it can interfere with the evaluation of the target hip according to the Investigator
- Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an HHS< 60 points
- Significant proven or suspicious infection of the target hip
- Any serious infectious disease before the study according to the Investigator
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- Muscular insufficiency that may compromise functional recovery
- Proven osteopenia and osteoporosis severe enough to compromise the stem support according to the Investigator
- Known or suspicious hypersensitivity to the metal of the implant
- Recurrent medical history of immune-mediated reactions or other systemic immune disorders
- Vascular insufficiency or peripheral neuropathy of lower limbs severe enough to interfere with the study evaluation according to the Investigator
- Current treatment or treatment for any malignancy within the previous 2 years before the preoperative visit
- Previous organ transplant
- Any intercurrent chronic disease or condition that may interfere with the completion of the 60-month follow-up, such as liver disease, severe coronary disease, or other clinically significant condition that the Investigator feels may affect the study evaluation
- Known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition
- Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
- Current alcoholism, and/or any known current addiction to pain medications or drugs
- Any psychiatric illness that would prevent comprehension of the details and nature of the study
- Participation in any experimental drug/device study within the 6 months prior to the preoperative visit
- Unwillingness or inability to comply with rehabilitation and to return for follow-up visits
- Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Prospective, Observational Clinical Study Evaluating the Outcomes of a Cementless Metaphyseal Short Stem After Hip Arthroplasty
Post-marketing clinical study,international, multi-centre, prospective, observational. The investigation will be carried out in 2 sites in Europe for a maximum total number of 160 patients.The aim of this study is to assess clinical, radiographic and subjective outcomes after hip arthroplasty with a cementless metaphyseal MINIMA short stem, define the survivorship of the implant and identify possible risk factors that may lead to failure.
- Conditions
- Total Hip Arthroplasty
- Being tested
- MINIMA stem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINIMA stemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score (HHS)
Measured: 24 months
UCLA activity score
Measured: 24 months
Time up and go test (TUG)
Measured: 24 months
Range of motion (ROM)
Measured: 24 months
Secondary outcomes (4)
Hip disability and Osteoarthritis Outcome Score (HOOS)
Measured: 24 months
Implant stability measured by radiographic evaluations
Measured: 24 months
Revision rate
Measured: 24 months
Incidence of device-related Adverse Events/Serious Adverse Events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startSep 2013
- Primary completionDec 2017
- Study completionFeb 2023
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 Limacorporate S.p.aThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luigi Zagra, Principal investigator, I.R.C.C.S. Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414542
- Sponsor's protocol ID
- H-11
- Status last verified
- Apr 2024
- First submitted
- 31 Mar 2015
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective, Observational Clinical Study Evaluating the Outcomes of a Cementless Metaphyseal Short Stem After Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02414542
- Acronym / sponsor ID
- H-11
- Conditions
- Total Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2023 (actual)
- First posted
- 10 Apr 2015 (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.
Post-marketing clinical study,international, multi-centre, prospective, observational. The investigation will be carried out in 2 sites in Europe for a maximum total number of 160 patients.The aim of this study is to assess clinical, radiographic and subjective outcomes after hip arthroplasty with a cementless metaphyseal MINIMA short stem, define the survivorship of the implant and identify possible risk factors that may lead to failure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected for recruitment into the study from the general diagnosis population of patients requiring a primary hip arthroplasty, due to symptomatic painful degenerative joint diseases (NDJD). Patients requiring a revision of a previous failed stem cannot be enrolled into the clinical evaluation.
Key inclusion criteria (10 listed)
- Both genders
- Age ≥ 18 years old
- Life expectancy over 5 years
- Any race
- Ambulatory patients
Key exclusion criteria (21 listed)
- Body mass index over 28 kg/m2 for the modular version
- Requiring revision of previous standard femoral stem
- Symptomatic OA of the knees, spine, ankles or contralateral hip, if it can interfere with the evaluation of the target hip according to the Investigator
- Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an HHS< 60 points
- Significant proven or suspicious infection of the target hip
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 |
|---|---|---|
| MINIMA stem | Device | – |
Primary outcome
Harris Hip Score (HHS)
Time frame: 24 months
UCLA activity score
Time frame: 24 months
Time up and go test (TUG)
Time frame: 24 months
Range of motion (ROM)
Time frame: 24 months
4 secondary outcomes
Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: 24 months
Implant stability measured by radiographic evaluations
Time frame: 24 months
Revision rate
Time frame: 24 months
Incidence of device-related Adverse Events/Serious Adverse Events
Time frame: 24 months
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 23 Apr 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. This study is not recruiting at the moment.
Luigi Zagra principal investigator
I.R.C.C.S. Galeazzi
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 Limacorporate S.p.a 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 10 inclusion and 21 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 23 Apr 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?
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?
Harris Hip Score (HHS) (time frame: 24 months). The study lists 4 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 23 Apr 2024.