ACTIS Hip Stem Implant Stability in Total Hip Arthroplasty
This study aims to compare the stability of the ACTIS hip stem implant over two years in individuals undergoing total hip replacement surgery.
ACTIS
Arthritis+3
+ Joint Diseases
+ Musculoskeletal Diseases
Other Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.64 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
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
Nova Scotia Health - Orthopedic
Halifax, CanadaLondon Health Sciences Centre
London, Canada