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Orthopedic Implant
Actis Total Hip System for Hip Replacement (Actis14014 Trial)
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Actis14014 Trial 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.Check my eligibility
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.See study design
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.
Actis14014 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Actis14014 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary endpoint - Harris Hip Score
Secondary outcome measures
Adverse Events
Device Survivorship
Harris Hip Score
+2 moreActis14014 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
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I need a hip replacement due to severe pain or disability from arthritis or hip dysplasia.I am willing to wear an activity tracking device before and after surgery as required.I can return the activity tracking device after 3 months.I am recommended to have partial hip replacement due to a specific type of hip fracture.I need a partial hip replacement due to a severe hip fracture.I need a partial hip replacement due to a severe hip injury that can't be fixed with surgery.I need a partial hip replacement due to dead bone tissue in my hip.I need a partial hip replacement due to a failed healing of a hip fracture.I am at least 21 years old.I am not confined to bed.I do not have any conditions that would prevent the use of my natural hip socket for surgery.I have not had a hip replacement on the opposite side within the last 6 months.I do not have osteoporosis or poor bone quality.I have not had an amputation on the opposite side of my body.I need a hip replacement due to a severe hip fracture.I need a hip replacement due to dead bone tissue in my hip.I do not have muscle loss, nerve or blood vessel problems.I need a hip replacement due to stiffening of my hip joint.I do not need both hips replaced at the same time.I do not have Charcot's or Paget's disease.I need surgery for my hip that involves only the ball of the joint, not the socket.I need a partial hip replacement due to arthritis affecting only the ball of my hip.I do not have any ongoing infections.I do not have a muscular disorder that limits my mobility.
Research Study Groups:
This trial has the following groups:- Group 1: Actis Total Hip System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are participating in this clinical investigation?
"Affirmative. According to the information provided by clinicaltrials.gov, this medical trial was first published on July 1st 2016 and is still actively seeking enrolment from 255 patients at a single site."
Answered by AI
Are applications still being taken for this medical study?
"Per the information available on clinicaltrials.gov, recruitment for this trial is still ongoing and began on July 1st 2016. The last update was made November 28th 2022."
Answered by AI
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