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Minima Clinical Study

Sponsor
Limacorporate S.p.a (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02414542
Collaborator
(none)
80
Enrollment
1
Location
99
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MINIMA stem

Study Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
A Multicentre, Prospective, Observational Clinical Study Evaluating the Outcomes of a Cementless Metaphyseal Short Stem After Hip Arthroplasty
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Harris Hip Score (HHS) [24 months]

  2. UCLA activity score [24 months]

  3. Time up and go test (TUG) [24 months]

  4. Range of motion (ROM) [24 months]

Secondary Outcome Measures

  1. Hip disability and Osteoarthritis Outcome Score (HOOS) [24 months]

  2. Implant stability measured by radiographic evaluations [24 months]

  3. Revision rate [24 months]

  4. Incidence of device-related Adverse Events/Serious Adverse Events [24 months]

Other Outcome Measures

  1. Mid-term clinical outcomes: Harris Hip Score and Hip disability and Osteoarthritis Outcome Score (HOOS) [60 months]

  2. Incidence of device-related Adverse Events and Serious Adverse Events [60 months]

  3. Survival rate (Kaplan Meier) [60 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 I.R.C.C.S. Galeazzi Milano Italy 20161

Sponsors and Collaborators

  • Limacorporate S.p.a

Investigators

  • Principal Investigator: Luigi Zagra, I.R.C.C.S. Galeazzi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Limacorporate S.p.a
ClinicalTrials.gov Identifier:
NCT02414542
Other Study ID Numbers:
  • H-11
First Posted:
Apr 10, 2015
Last Update Posted:
Apr 2, 2021
Last Verified:
Apr 1, 2021

Study Results

No Results Posted as of Apr 2, 2021