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Hip Stem

ACTIS Hip Stem for Hip Osteoarthritis

N/A
Waitlist Available
Led By Thomas Turgeon, MD
Research Sponsored by Canadian Radiostereometric Analysis Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty
Aged 21 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights

Study Summary

This trial is comparing the subsidence of a new hip stem to other similar hip stems. They will also look at things like complications and health status changes after surgery.

Who is the study for?
This trial is for adults over 21 with symptomatic osteoarthritis of the hip who need a total hip replacement and can follow the study's procedures. They must have a BMI ≤45 kg/m2. It excludes those with prior hip surgeries, infections, certain spine conditions, life expectancy under 2 years, or skin issues near the incision area.Check my eligibility
What is being tested?
The ACTIS femoral stem is being tested in this study to see if it moves less than similar designs after two years when used in hip replacements. The trial will also look at how well patients recover and any complications that might happen during surgery.See study design
What are the potential side effects?
While specific side effects are not listed for ACTIS itself, typical risks associated with hip replacement may include pain at the site, infection risk post-surgery, blood clots, dislocation of the implant and possible need for revision surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I need a hip replacement due to severe arthritis pain.
Select...
I am 21 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Subsidence of the ACTIS femoral stem
Secondary outcome measures
Comparison of migration per surgical approach
European Quality of Life (EQ-5D-5L) questionnaire
Oxford Hip Score (OHS)
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ACTIS hip stemExperimental Treatment1 Intervention
All participants will receive the ACTIS hip stem.

Find a Location

Who is running the clinical trial?

Canadian Radiostereometric Analysis NetworkLead Sponsor
7 Previous Clinical Trials
331 Total Patients Enrolled
DePuy SynthesIndustry Sponsor
30 Previous Clinical Trials
4,860 Total Patients Enrolled
Thomas Turgeon, MDPrincipal InvestigatorUniversity of Manitoba
8 Previous Clinical Trials
317 Total Patients Enrolled

Media Library

ACTIS (Hip Stem) Clinical Trial Eligibility Overview. Trial Name: NCT04879732 — N/A
Hip Osteoarthritis Research Study Groups: ACTIS hip stem
Hip Osteoarthritis Clinical Trial 2023: ACTIS Highlights & Side Effects. Trial Name: NCT04879732 — N/A
ACTIS (Hip Stem) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04879732 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any participants being recruited currently for this research study?

"Yes, this study is still open to enrollment. Initially posted on October 5th 2021, the trial was most recently updated on November 1st 2022 and seeks 60 participants at two separate sites."

Answered by AI

How many participants is the research team recruiting for this study?

"Affirmative. The clinicaltrials.gov website states that this medical trial is recruiting now, with the first post being made on October 5th 2021 and updated most recently on November 1st 2022. In total, 60 people need to be enrolled at two different sites for the study to proceed."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Orthopaedic Innovation Centre
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
RSA - ACTIS Hip Stem
2021. "RSA - ACTIS Hip Stem". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04879732.
~13 spots leftby Dec 2024
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