Minima Clinical Study

NCT ID: NCT02414542

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2023-02-28

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.

Conditions

Total Hip Arthroplasty

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

MINIMA stem

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Limacorporate S.p.a

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luigi Zagra

Role: PRINCIPAL_INVESTIGATOR

I.R.C.C.S. Galeazzi

Locations

I.R.C.C.S. Galeazzi

Milan, , Italy

Countries

Italy

Other Identifiers

H-11

Identifier Type: -

Identifier Source: org_study_id