NCT04879732

RSA - ACTIS Hip Stem

Roentgen Stereophotogrammetric Analysis (RSA): ACTIS Hip Stem

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Canadian Radiostereometric Analysis Network · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Hip Osteoarthritis

Interventions

Type	Name	Description
DEVICE	ACTIS	ACTIS Hip stem

Timeline

• Start date: 2021-10-05
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2021-05-10
• Last updated: 2025-12-04

Locations

3 sites across 1 country: Canada

Regulatory

• FDA-regulated device study