ACTIS Hip Stem for Hip Osteoarthritis

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new hip implant called the ACTIS hip stem for individuals with hip osteoarthritis, a condition causing joint pain and stiffness. The main goal is to assess how well this implant remains in place two years after surgery compared to similar implants. Researchers will also examine how different surgical methods affect outcomes and monitor any changes in patients’ health and complications post-surgery. Individuals with hip pain from osteoarthritis who are considering hip replacement surgery might be suitable candidates if they have a body mass index of 45 or less and no prior hip surgeries. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future hip replacement options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the ACTIS hip stem is safe for hip osteoarthritis?

Research has shown that the ACTIS hip stem is very safe for patients. One study found that 98.8% of patients did not require additional surgery five years after receiving this hip system, indicating that almost all patients experienced no major issues. Another report showed excellent results, with no need for further surgery at the five-year mark.

The ACTIS hip stem is designed to help doctors perform surgeries that better protect tissue, likely reducing complications after surgery. Overall, the data suggest that the ACTIS hip stem is well-tolerated, with very few complications in the years following surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard hip replacements for osteoarthritis, which often use traditional metal or ceramic components, the ACTIS Hip Stem is designed with advanced materials that aim to improve fit and longevity. Researchers are excited about this treatment because it features a unique geometry and coating that may enhance bone integration, potentially leading to a more stable and longer-lasting hip replacement. This innovative approach could offer patients improved mobility and reduced risk of complications compared to existing options.

What evidence suggests that the ACTIS hip stem is effective for hip osteoarthritis?

Research has shown that the ACTIS hip stem is promising for treating hip osteoarthritis. One study found that five years after surgery, 98.8% of patients with the ACTIS hip system did not require additional surgery, indicating the implant's durability. All implants remained secure without loosening. Studies following patients for two years have demonstrated good results, comparing well to other hip implants. These consistent findings suggest that the ACTIS hip stem can effectively improve hip function and reduce pain. ^{1 3 6 7 8}

Who Is on the Research Team?

Thomas Turgeon, MD

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11743641/

Mid-term Clinical and Radiographic Outcomes of the Actis ... The survival rate of patients with the Actis Total Hip System was 98.8% five years after surgery. All stems were stable, without any signs of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02783274

NCT02783274 | Actis Total Hip System 2 Year Follow-up Two-year (2 year) information regarding the performance of the commercially available Actis™ Total Hip System in order to obtain and evaluate the clinical ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/03007995.2023.2181150

Real-world 2-year clinical and economic outcomes among ... To evaluate real-world outcomes of patients receiving ACTIS, a medial collared, triple-tapered (MCTT) hip system vs. other implants, for primary total hip ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8780166/

5-Year Clinical and Radiographic Results of the Direct ... The aim of this study was to investigate the radiological and clinical outcome of the direct anterior approach (DAA) in total hip arthroplasty ( ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/10225536251340118

Outcomes of 1021 consecutive cases utilizing a triple ... There have been no large, longer-term follow-up studies reporting the clinical and radiographic results associated with the ACTIS stem implanted ...

6. jnjmedtech.com jnjmedtech.com/sites/default/files/user_uploaded_assets/pdf_assets/2021-12/167430-210217%20ACTIS%20Total%20Hip%20System%20Clinical%20Update%20WP_V10_Approved.pdf?sf157082222=1

ACTIS® Total Hip System: Different sources of information demonstrate that the. ACTIS Hip Femoral Stem has excellent clinical outcomes, and no revision rates at 5 years were reported ...

7. jnjinstitute.com jnjinstitute.com/sites/default/files/2019-06/DSUSJRC07172231-ACTIS-Early-Performance-Data-Collection.pdf

ACTIS™ TOTAL HIP SYSTEM: EARLY CLINICAL RESULTS The ACTIS Total Hip System was designed to provide surgeons with a prosthesis system to aid tissue sparing surgical approaches, such as the anterior approach.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11141789/

Five-Year Survivorship of Total Hip Arthroplasty With a ... Our evaluation demonstrates excellent construct and stem survivorship and very low complication rates at midterm postoperative follow-up.