RSA - ACTIS Hip Stem

Canadian Radiostereometric Analysis Network64 enrolled

Overview

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.

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hip Osteoarthritis

Interventions

ACTISDEVICE

ACTIS Hip stem

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Orthopaedic Innovation Centre

Winnipeg, Manitoba, Canada

Nova Scotia Health - Orthopedic

Halifax, Nova Scotia, Canada

London Health Sciences Centre

London, Ontario, Canada

Outcomes

Primary Outcomes

Subsidence of the ACTIS femoral stem

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.

Time frame: 2 Year

Secondary Outcomes

Comparison of migration per surgical approach

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.

Time frame: 2 Year

Oxford Hip Score (OHS)

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.

Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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.

Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years

European Quality of Life (EQ-5D-5L) questionnaire

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.

Data from ClinicalTrials.gov

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