Minima Clinical Study

NCT02414542 | Completed

• 1 other identifier: H-11
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Harris Hip Score (HHS)

  24 months

• UCLA activity score

  24 months

• Time up and go test (TUG)

  24 months

• Range of motion (ROM)

  24 months

Secondary Outcomes (4)

• 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

Other Outcomes (3)

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

  60 months

• Incidence of device-related Adverse Events and Serious Adverse Events

  60 months

• Survival rate (Kaplan Meier)

  60 months

Interventions

MINIMA stem DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected for recruitment into the study from the general diagnosis population of patients requiring a primary hip arthroplasty, due to symptomatic painful degenerative joint diseases (NDJD). Patients requiring a revision of a previous failed stem cannot be enrolled into the clinical evaluation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (1)

I.R.C.C.S. Galeazzi

Milan, 20161, Italy

Location

Study Officials

• Luigi Zagra

  I.R.C.C.S. Galeazzi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 10, 2015
• Study Start: September 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

IT (1)