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New hip implant tracked for 10 years – will it last?

NCT ID NCT05460715

Disease control Sponsor: Medacta International SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 300 adults aged 18-75 who received a specific type of hip implant (Quadra-P stem) during hip replacement surgery. The goal is to see how well the implant works over 10 years, including how long it lasts and how it improves pain and movement. Participants have conditions like arthritis, hip dysplasia, or bone damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Jul 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The aim of the study is to monitor the clinical performance and survival of the Quadra-P antevert stem when used according to its indications. Since patients are not subjected to additional risks or procedures compared to standard practice, the total number of patients was defined on the basis of the surgeon's potential and observational studies of the same type already published in the literature. For the anatomical-functional subgroup, a sample size was defined to verify 10% speed increases between pre- and postoperative. Considering α = 5% and Power = 90%, 30 patients will be required.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects suffering from primary hip arthrosis, post-traumatic arthrosis, dysplasia or avascular necrosis of the femoral head, rheumatoid arthritis * Adult subjects between 18 and 75 years of age on the date of surgery * Subjects eligible for primary total hip arthroplasty surgery for whom the anterior Quadra-P femoral component will be implanted according to the indications for use of the implant * Subjects who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to surgery. For the anatomical-functional subgroup: \- Adult subjects aged between 18 and 65 years at the date of surgery who have agreed to undergo the gait analysis study. Exclusion Criteria: * Subjects with acute or chronic infection * Subjects with a femoral neck fracture * Subjects with mental conditions that impair their ability to consent to the study, to complete required questionnaires or to complete follow-up visits * Subjects with severe deformities, at the discretion of the surgeon * Subjects with metabolic disorders that may involve bone metabolism for which an uncemented implant would be contraindicated * Subjects with muscular atrophy or neuromuscular diseases * Subjects allergic to the materials used during surgery * Subjects unable or unwilling to provide consent for participation in the study * Any other condition not mentioned in the inclusion criteria

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Conditions

The condition(s) this trial relates to.

arthropathy avascular necrosis of femoral head, primary, 1 developmental dysplasia of the hip familial avascular necrosis of femoral head Hip Dislocation, Congenital osteoarthritis osteoarthritis, hip rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthrosis Avascular necrosis of the femoral head Congenital hip dysplasia Rheumatoid polyarthritis Traumatic arthritis

Contacts and locations

Locations

  • Istituto Ortopedico Franco Scalabrino

    Messina, Messina, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.