Minima Clinical Study

Completed

• Conditions: Total Hip Arthroplasty

• Registration Number: NCT02414542
• Lead Sponsor: Limacorporate S.p.a

Brief 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 metaphyseal MINIMA short stem, define the survivorship of the implant and identify possible risk factors that may lead to failure.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-04-07
• Study First Posted: 2015-04-10
• Primary Completion: 2017-12
• Study Completion: 2023-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Both genders
2. Age ≥ 18 years old
3. Life expectancy over 5 years
4. Any race
5. Ambulatory patients
6. Painful primary coxarthrosis
7. Painful secondary coxarthrosis
8. Avascular necrosis
9. Willingness to comply with rehabilitation and study evaluation and ability to return for follow-up visits
10. Signed study-specific Informed Consent Form

Exclusion Criteria

1. Body mass index over 28 kg/m2 for the modular version
2. Requiring revision of previous standard femoral stem
3. 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
4. Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an HHS< 60 points
5. Significant proven or suspicious infection of the target hip
6. Any serious infectious disease before the study according to the Investigator
7. Muscular insufficiency that may compromise functional recovery
8. Proven osteopenia and osteoporosis severe enough to compromise the stem support according to the Investigator
9. Known or suspicious hypersensitivity to the metal of the implant
10. Recurrent medical history of immune-mediated reactions or other systemic immune disorders
11. Vascular insufficiency or peripheral neuropathy of lower limbs severe enough to interfere with the study evaluation according to the Investigator
12. Current treatment or treatment for any malignancy within the previous 2 years before the preoperative visit
13. Previous organ transplant
14. 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
15. Known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition
16. Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
17. Current alcoholism, and/or any known current addiction to pain medications or drugs
18. Any psychiatric illness that would prevent comprehension of the details and nature of the study
19. Participation in any experimental drug/device study within the 6 months prior to the preoperative visit
20. Unwillingness or inability to comply with rehabilitation and to return for follow-up visits
21. 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
UCLA activity score	24 months
Range of motion (ROM)	24 months
Time up and go test (TUG)	24 months
Harris Hip Score (HHS)	24 months

Secondary Outcome Measures

Name	Time	Method
Hip disability and Osteoarthritis Outcome Score (HOOS)	24 months
Implant stability measured by radiographic evaluations	24 months
Revision rate	24 months
Incidence of device-related Adverse Events/Serious Adverse Events	24 months

Trial Locations

Locations (1)

I.R.C.C.S. Galeazzi; 🇮🇹 Milano, Italy