RSA - ACTIS Hip Stem

December 19, 2023 updated by: Canadian Radiostereometric Analysis Network

Roentgen Stereophotogrammetric Analysis (RSA): ACTIS Hip Stem

The principal objective of this study is to compare mean 2-year subsidence of the ACTIS femoral stem using model-based RSA against published migration patterns for hip stems of a similar design. Secondary objectives include comparison of migration per surgical approach, quantifying changes in functional and health status of subjects following surgery, and assess occurrences of complications and adverse events.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Manitoba
      • Winnipeg, Manitoba, Canada, R2K 2M9
        • Orthopaedic Innovation Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2E1
        • Nova Scotia Health - Orthopedic
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

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

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.
ACTIS Hip stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subsidence of the ACTIS femoral stem
Time Frame: 2 Year
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.
2 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of migration per surgical approach
Time Frame: 2 Year
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.
2 Year
Oxford Hip Score (OHS)
Time Frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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.
Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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.
Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
European Quality of Life (EQ-5D-5L) questionnaire
Time Frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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.
Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Visual analogue scale (VAS) for thigh pain
Time Frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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).
Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Visual analogue scale (VAS) for satisfaction
Time Frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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).
Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
University of California at Los Angeles (UCLA) Activity Level scale
Time Frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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.
Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Thomas Turgeon, MD, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 30, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • B2021:005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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3
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