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Completed

NCT Number: NCT04879732

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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Innovation Centre, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACTIS

Device

ACTIS Hip stem

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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.

Sponsors and collaborators

Lead sponsor

Canadian Radiostereometric Analysis Network

Other

Collaborators

  • DePuy Synthes

Registry information

Official study title

Roentgen Stereophotogrammetric Analysis (RSA): ACTIS Hip Stem

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 10, 2021
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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