- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02414542
Minima Clinical Study
April 22, 2024 updated by: Limacorporate S.p.a
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Milano, Italy, 20161
- I.R.C.C.S. Galeazzi
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Both genders
- Age ≥ 18 years old
- Life expectancy over 5 years
- Any race
- Ambulatory patients
- Painful primary coxarthrosis
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Harris Hip Score (HHS)
Time Frame: 24 months
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24 months
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UCLA activity score
Time Frame: 24 months
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24 months
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Time up and go test (TUG)
Time Frame: 24 months
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24 months
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Range of motion (ROM)
Time Frame: 24 months
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24 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hip disability and Osteoarthritis Outcome Score (HOOS)
Time Frame: 24 months
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24 months
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Implant stability measured by radiographic evaluations
Time Frame: 24 months
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24 months
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Revision rate
Time Frame: 24 months
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24 months
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Incidence of device-related Adverse Events/Serious Adverse Events
Time Frame: 24 months
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24 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mid-term clinical outcomes: Harris Hip Score and Hip disability and Osteoarthritis Outcome Score (HOOS)
Time Frame: 60 months
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60 months
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Incidence of device-related Adverse Events and Serious Adverse Events
Time Frame: 60 months
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60 months
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Survival rate (Kaplan Meier)
Time Frame: 60 months
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60 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Luigi Zagra, I.R.C.C.S. Galeazzi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
February 1, 2023
Study Registration Dates
First Submitted
March 31, 2015
First Submitted That Met QC Criteria
April 7, 2015
First Posted (Estimated)
April 10, 2015
Study Record Updates
Last Update Posted (Actual)
April 23, 2024
Last Update Submitted That Met QC Criteria
April 22, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- H-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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