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Orthopedic Implant

Actis Total Hip System for Hip Replacement (Actis14014 Trial)

N/A

Waitlist Available

Research Sponsored by DePuy Orthopaedics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Total primary hip replacement is indicated in conditions such as severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia

Total primary hip replacement is indicated in conditions such as acute traumatic fracture of the femoral head or neck

Must not have

Subjects will be excluded if they have poor bone quality such as osteoporosis

Subjects will be excluded if they had a contralateral amputation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Summary

This trial looked at the outcomes of using the Actis Total Hip System in cementless primary THA and hemi-hip arthroplasty procedures. Clinical, radiographic, and device and procedure related adverse event assessments were used to evaluate the performance of the system.

Who is the study for?

This trial is for adults over 21 with hip-related conditions like osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, or certain fractures. Candidates must be able to follow the study protocol and complete questionnaires. Exclusions include pregnant women, recent participants in other trials, those with severe psychological disorders or substance abuse issues, and individuals with specific medical conditions that could affect outcomes.

What is being tested?

The Actis Total Hip System is being tested in patients requiring total hip arthroplasty (THA) or hemi-hip arthroplasty due to various hip pathologies. The study aims to evaluate clinical outcomes over two years through assessments of device performance and related adverse events.

What are the potential side effects?

While not explicitly listed here, potential side effects may include pain at the surgery site, infection risks associated with any surgical procedure involving implants, possible allergic reactions to materials used in the system, and complications such as implant loosening or dislocation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need a hip replacement due to severe pain or disability from arthritis or hip dysplasia.

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I need a hip replacement due to a severe hip fracture.

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I need a partial hip replacement due to a severe hip fracture.

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I need a partial hip replacement due to a severe hip injury that can't be fixed with surgery.

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I need a partial hip replacement due to a failed healing of a hip fracture.

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I am at least 21 years old.

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I am not confined to bed.

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I need a hip replacement due to dead bone tissue in my hip.

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I need surgery for my hip that involves only the ball of the joint, not the socket.

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I need a partial hip replacement due to arthritis affecting only the ball of my hip.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have osteoporosis or poor bone quality.

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I have not had an amputation on the opposite side of my body.

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I do not have any conditions that would prevent the use of my natural hip socket for surgery.

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I do not need both hips replaced at the same time.

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I do not have Charcot's or Paget's disease.

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I do not have muscle loss, nerve or blood vessel problems.

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I do not have any ongoing infections.

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I do not have a muscular disorder that limits my mobility.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary endpoint - Harris Hip Score

Secondary study objectives

Adverse Events

Device Survivorship

Harris Hip Score

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Actis Total Hip SystemExperimental Treatment1 Intervention

The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Actis Total Hip System

2016

N/A

~260

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

DePuy OrthopaedicsLead Sponsor

79 Previous Clinical Trials

25,584 Total Patients Enrolled

44 Trials studying Osteoarthritis

10,658 Patients Enrolled for Osteoarthritis

Deborah German, BSStudy DirectorDePuy Synthes

Media Library

Actis Total Hip System (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT02783274 — N/A

Osteoarthritis Research Study Groups: Actis Total Hip System

Osteoarthritis Clinical Trial 2023: Actis Total Hip System Highlights & Side Effects. Trial Name: NCT02783274 — N/A

Actis Total Hip System (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02783274 — N/A

~28 spots leftby Oct 2025

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