ACTIS Hip Stem for Hip Osteoarthritis

Recruiting at 2 trial locations

Overseen By Sarah Tran

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Canadian Radiostereometric Analysis Network

Disqualifiers: Infection, Major surgery risk, Life expectancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

64 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well the ACTIS femoral hip stem works for patients needing hip replacement surgery. The new hip stem is designed to fit into the thigh bone and help patients move more easily and with less pain. The ACTIS femoral hip stem is a new design aimed at improving fit and reducing pain for patients undergoing hip replacement surgery.

Research Team

Thomas Turgeon, MD

Principal Investigator

University of Manitoba

Eligibility Criteria

This trial is for adults over 21 with symptomatic osteoarthritis of the hip who need a total hip replacement and can follow the study's procedures. They must have a BMI ≤45 kg/m2. It excludes those with prior hip surgeries, infections, certain spine conditions, life expectancy under 2 years, or skin issues near the incision area.

Inclusion Criteria

Patients willing and able to comply with follow-up requirements and self-evaluations

Ability to give informed consent

I need a hip replacement due to severe arthritis pain.

Exclusion Criteria

I have had surgery to join two or more bones in my lower back.

The skin where I will be cut for surgery is healthy.

I have or had an infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo primary total hip arthroplasty and initial recovery

6 weeks

1 visit (in-person)

Post-operative Monitoring

Model-based RSA is used to monitor implant migration and patient health outcomes are recorded

2 years

Multiple visits at 6 weeks, 3 months, 6 months, 1 year, and 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• ACTIS

Trial Overview The ACTIS femoral stem is being tested in this study to see if it moves less than similar designs after two years when used in hip replacements. The trial will also look at how well patients recover and any complications that might happen during surgery.

Participant Groups

Group I: ACTIS hip stem Experimental Treatment 1 Intervention

All participants will receive the ACTIS hip stem.

Who Is Running the Clinical Trial?

Canadian Radiostereometric Analysis Network

Lead Sponsor

Trials

9

Recruited

420+

DePuy Synthes

Industry Sponsor

Trials

33

Recruited

4,900+