Completed

ACTIS Hip Stem Implant Stability in Total Hip Arthroplasty

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Study Aim

This study aims to compare the stability of the ACTIS hip stem implant over two years in individuals undergoing total hip replacement surgery.

What is being tested

ACTIS

Device
Who is being recruted

Arthritis+3

+ Joint Diseases

+ Musculoskeletal Diseases

Over 21 Years
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: October 2021
See protocol details

Summary

Principal SponsorCanadian Radiostereometric Analysis Network
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 5, 2021

Actual date on which the first participant was enrolled.

This study focuses on patients who are having their first total hip replacement surgery, specifically using a device called the ACTIS femoral hip stem. It takes place across three Canadian medical centers, where each patient will receive the implant through one of three surgical methods. The main goal is to observe how well the implant stays in place over the first two years after surgery. By tracking the movement of the implant, the study aims to provide valuable insights into which surgical approaches might offer the best stability and patient outcomes. This information is crucial for improving recovery and ensuring better long-term results for those undergoing hip replacement. Participants in the study will undergo the hip replacement surgery and then have their progress monitored through various methods. A special imaging technique called Roentgen Stereophotogrammetric Analysis (RSA) will be used to take detailed pictures of the implant to see how much it moves over time. Health and functional improvements will be assessed before and after surgery to track recovery. Additionally, any side effects or complications will be documented to ensure patient safety. By collecting data on the surgery, hospital stay, and rehabilitation, researchers aim to also understand the economic aspects of the treatment, making it possible to compare costs and benefits among the different surgical approaches.

Official TitleRoentgen Stereophotogrammetric Analysis (RSA): ACTIS Hip Stem
NCT04879732
Principal SponsorCanadian Radiostereometric Analysis Network
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

64 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic DiseasesOsteoarthritis, Hip

Criteria

Inclusion Criteria: * Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty * Aged 21 years or older * Patients willing and able to comply with follow-up requirements and self-evaluations * Ability to give informed consent * Body mass index ≤45 kg/m2 Exclusion Criteria * Active or prior infection * Medical condition precluding major surgery * Medical condition with less than 2 years life expectancy * Overhanging pannus (for anterior approach cohort only) * Prior surgery of the hip involving implantation of hardware (i.e., hemiarthroplasty, internal fixation, pelvic reconstruction near the acetabulum requiring removal) * Skin condition on the area of incision * Multi-level lumbar spine fusion * Ankylosing spondylolithesis * Shortening osteotomy through the femur

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

All participants will receive the ACTIS hip stem.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Orthopaedic Innovation Centre

Winnipeg, CanadaOpen Orthopaedic Innovation Centre in Google Maps
Suspended

Nova Scotia Health - Orthopedic

Halifax, Canada
Suspended

London Health Sciences Centre

London, Canada
Completed3 Study Centers