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Completed

NCT Number: NCT02414542

Minima Clinical Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

I.R.C.C.S. Galeazzi

Milan, 20161, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MINIMA stem

Device

Primary outcomes

  1. Harris Hip Score (HHS)

    Time frame: 24 months

  2. UCLA activity score

    Time frame: 24 months

  3. Time up and go test (TUG)

    Time frame: 24 months

  4. Range of motion (ROM)

    Time frame: 24 months

Secondary outcomes

  1. Hip disability and Osteoarthritis Outcome Score (HOOS)

    Time frame: 24 months

  2. Implant stability measured by radiographic evaluations

    Time frame: 24 months

  3. Revision rate

    Time frame: 24 months

  4. Incidence of device-related Adverse Events/Serious Adverse Events

    Time frame: 24 months

Other outcomes

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

    Time frame: 60 months

  2. Incidence of device-related Adverse Events and Serious Adverse Events

    Time frame: 60 months

  3. Survival rate (Kaplan Meier)

    Time frame: 60 months

Sponsors and collaborators

Lead sponsor

Limacorporate S.p.a

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2023
First posted
Apr 10, 2015
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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