Minima Clinical Study

Total Hip Arthroplasty Clinical Trial

Official title:

A Multicentre, Prospective, Observational Clinical Study Evaluating the Outcomes of a Cementless Metaphyseal Short Stem After Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414542
• Other study ID #: H-11
• Status: Completed
• Start date: September 2013
• Est. completion date: February 2023

Study information

• Verified date: April 2024
• Source: Limacorporate S.p.a
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2023
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Device:
• MINIMA stem

Locations

Country	Name	City	State
Italy	I.R.C.C.S. Galeazzi	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Limacorporate S.p.a

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mid-term clinical outcomes: Harris Hip Score and Hip disability and Osteoarthritis Outcome Score (HOOS)		60 months
Other	Incidence of device-related Adverse Events and Serious Adverse Events		60 months
Other	Survival rate (Kaplan Meier)		60 months
Primary	Harris Hip Score (HHS)		24 months
Primary	UCLA activity score		24 months
Primary	Time up and go test (TUG)		24 months
Primary	Range of motion (ROM)		24 months
Secondary	Hip disability and Osteoarthritis Outcome Score (HOOS)		24 months
Secondary	Implant stability measured by radiographic evaluations		24 months
Secondary	Revision rate		24 months
Secondary	Incidence of device-related Adverse Events/Serious Adverse Events		24 months