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RSA - ACTIS Hip Stem

NCT04879732 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-12-04

No results posted yet for this study

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

Interventions

DEVICE

ACTIS

ACTIS Hip stem

Sponsors & Collaborators

  • DePuy Synthes

    collaborator INDUSTRY

  • Canadian Radiostereometric Analysis Network

    lead OTHER

Principal Investigators

  • Thomas Turgeon, MD · University of Manitoba

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-05
Primary Completion
2025-05-30
Completion
2025-05-30
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04879732 on ClinicalTrials.gov