Status:
COMPLETED
RSA - ACTIS Hip Stem
Lead Sponsor:
Canadian Radiostereometric Analysis Network
Collaborating Sponsors:
DePuy Synthes
Conditions:
Hip Osteoarthritis
Eligibility:
All Genders
21+ years
Phase:
NA
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. Secon...
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 vi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04879732
Start Date
October 5 2021
End Date
May 30 2025
Last Update
December 4 2025
Active Locations (3)
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1
Orthopaedic Innovation Centre
Winnipeg, Manitoba, Canada, R2K 2M9
2
Nova Scotia Health - Orthopedic
Halifax, Nova Scotia, Canada, B3H 2E1
3
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9