RSA - ACTIS Hip Stem

NCT04879732 | Completed FDA Device

• 1 other identifier: B2021:005
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  2 Year

Secondary Outcomes (7)

• Comparison of migration per surgical approach

  2 Year

• Oxford Hip Score (OHS)

  Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years

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

  Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years

• Visual analogue scale (VAS) for thigh pain

  Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years

Study Arms (1)

ACTIS hip stem

OTHER

All participants will receive the ACTIS hip stem.

Device: ACTIS

Interventions

ACTIS DEVICE

ACTIS Hip stem

ACTIS hip stem

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Radiostereometric Analysis Network: lead
• DePuy Synthes: collaborator

Study Sites (3)

Orthopaedic Innovation Centre

Winnipeg, Manitoba, R2K 2M9, Canada

Location

Nova Scotia Health - Orthopedic

Halifax, Nova Scotia, B3H 2E1, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Thomas Turgeon, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 10, 2021
• Study Start: October 5, 2021
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CA (3)