- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04879732
RSA - ACTIS Hip Stem
Roentgen Stereophotogrammetric Analysis (RSA): ACTIS Hip Stem
Study Overview
Detailed Description
This is a multi-centre, sequential enrollment trial of patients undergoing primary total hip arthroplasty. Patients will be recruited at three Canadian Centres to receive the ACTIS femoral hip stem via 3 different surgical approaches.
Model-based RSA will identify migration of the implant with respect to the femoral bone during the first 2 post-operative years. Patient health and functional outcomes will be recorded at pre- and post-operative intervals to quantify improvement as a result of the surgery and trajectory of recovery. Adverse events and clinical complications in each study group will be captured and compared. Select surgical, hospital and rehabilitation data will be collected to measure health economic outcomes relating to the surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R2K 2M9
- Orthopaedic Innovation Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2E1
- Nova Scotia Health - Orthopedic
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Ontario
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London, Ontario, Canada, N6A 5W9
- London Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: ACTIS hip stem
All participants will receive the ACTIS hip stem.
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ACTIS Hip stem
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subsidence of the ACTIS femoral stem
Time Frame: 2 Year
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Compare mean 2-year subsidence using model-based RSA (radiostereometric analysis) (mm).
The images taken at each time point will be compared with the baseline to assess the change in implant position.
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2 Year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of migration per surgical approach
Time Frame: 2 Year
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Comparison between the 3 approaches (postero-lateral, direct lateral, and direct anterior); measured migration (mm).
The images taken at each time point will be compared with the baseline to assess implant migration.
Therefore the outcome is change in implant position measured using RSA.
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2 Year
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Oxford Hip Score (OHS)
Time Frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments, patient reported outcome.
Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance.
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Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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Evaluate and compare the change from preoperative to 2 years between the study groups and timepoints.
The scores in each section (pain, stiffness and function limitation) are totaled; 5 items for pain (score range 0-20), 2 for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
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Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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European Quality of Life (EQ-5D-5L) questionnaire
Time Frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments, patient reported outcome.
A health state score is obtained based on the responses from 1-5 in each subscale, from which a single index value is calculated representing patients' overall health state.
The overall health state range from 0 to 1.0.
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Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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Visual analogue scale (VAS) for thigh pain
Time Frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (No pain) - 100 (Worst pain imaginable).
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Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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Visual analogue scale (VAS) for satisfaction
Time Frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported pain severity as measured using the visual analogue scale (VAS) from 0 (Unsatisfied) - 100 (Completely satisfied).
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Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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University of California at Los Angeles (UCLA) Activity Level scale
Time Frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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Evaluate and compare the change in UCLA activity score compared to baseline in the study cohort.
UCLA activity scores range from 1 to 10, and is a measure of activity with 10 being most active.
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Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Thomas Turgeon, MD, University of Manitoba
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2021:005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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