Mpact 3D Metal Cup PMS

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMedacta International SA

About this trial

Cementless fixation, with or without screw augmentation, has evolved during the past few decades as the preferred method for acetabular reconstruction. Although major improvements have been recorded with regard to clinical outcomes and survivorship, acetabular component loosening remains among the most common causes of failure and revision. Patient age, poor bone quality and conditions, such as osteonecrosis and dysplasia, have been observed to influence negatively long-term clinical results.

Initial stability is fundamental for survivorship of cementless cups. Prerequisites to achieve durable cementless cup fixation are close contact with viable native bone, primary mechanical stability and secondary bone integration. Press-fit techniques provide optimal conditions for bone ingrowth and fixation but research focused on cup material in order to improve primary stability. Pore size, bone-implant apposition, and material properties all influence bone ingrowth and long-term stability.

Biological ingrowth surfaces have become a standard prosthetic element in reconstructive hip surgery. A material's properties, three-dimensional architecture, and surface texture all play integral parts in its biological performance. Trabecular metal is an important new biomaterial that has been introduced to enhance the potential of biological ingrowth as well as provide a structural scaffold in cases of severe bone deficit. The continuity between the porous and solid parts has been specifically developed to overcome the limitations of the traditional porous coatings. In fact, the absence of an interface between the trabecular structure and the bulk material provides greater structural solidity and thus higher resistance to detachment and corrosion. Initial clinical applications have focused on bone restoration in tumor and salvage cases and in primary and revision reconstructive cases where the increased biological fixation would be of clinical benefit. However the bone ingrowth potential and mechanical integrity of this material offer exciting options for orthopedic reconstructive surgeons such as difficult THA cases, such as patients with high demands, subjects affected by severe hip conditions (i.e. osteonecrosis, dysplasia) or with extremely poor bone quality. Medacta Mpact 3D Metal cup, is an acetabular cup realized using the EBM (Electron Beam Melting) powder technology; this production method offers a high friction and scratch-fit feel for the initial stability, without the need of any additional coating. Moreover the 3D Metal structure creates a favorable environment for bone thus providing secondary fixation.

The aim of this study is to evaluate the long term clinical and radiological performance of MPact 3D Metal acetabular component.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Those suffering from hip primary arthrosis, post-traumatic arthrosis, hip dysplasia or avascular necrosis of femoral head, rheumatic arthrosis

Those aged between 18 and 75 years old at the surgery time

those suitable to undergo to a primary total hip arthroplasty for whom the Mpact 3D Metal cup will be implanted (according to the label indication/contraindications)

Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to patient's surgery

Disqualifiers

Those with acute or chronic infection

Those whose mental conditions may compromise their ability to provide informed consent to study participation, ability to complete questionnaires or complete 10-year follow-ups.

Those suffered by severe deformation, at the discretion of surgeon

Those suffered by osteoporosis

Trial population

No sample size calculation has been performed; the number of patients has been defined according to the ODEP panel directive (Orthopaedic Data Evaluation Panel), for a long term post-marketing observational study. The number of patients is in line with long term observational study and considered sufficient to evaluate 10 years survival rate of the cup.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Mpact 3D metal cup

    Device

    Subjects, among those whose clinical condition makes them eligible for a primary total hip arthroplasty, will be invited to participate to the study during preoperative visit. They'll receive the Mpact 3D metal cup device

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Mpact 3d metal1 intervention

Trial outcomes

Primary outcomes

1

long term performance

Device survival will be assessed by Kaplan Meier curve

Time frame
10 years

Secondary outcomes

1

Clinical performance

Harris Hip Score collected during preoperative and follow-up visits. Harris Hip score scale correspond to 0-100 points. Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.

Time frame
3 months, 1, 5, 7 and 10 years after surgery
2

Radiological performance

standard x-ray exam performed preoperatively and postoperatively before discharge from hospital and during follow-up visits

Time frame
3 months, 1, 5, 7 and 10 years after surgery
3

Hip physical function after surgery

HOOS-PS score collected during preoperative visit and follow-up visit. HOOS PS scale correspond to 100 (no difficulty) to 0 (extreme difficulty) scale.

Time frame
3 months and 1, 5, 7 and 10 years after surgery
4

Rate of complications

collection of adverse events

Time frame
up to 10 years after surgery

Other outcomes

Sponsors and contacts

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