What side effects are associated with this type of intervention?

Common treatments for hip osteoarthritis, particularly hip replacement surgery using implants like the ACTIS Femoral Stem, carry risks such as infection, blood clots, implant loosening, dislocation, nerve damage, and differences in leg length. Medications used in managing hip osteoarthritis, such as NSAIDs and glucocorticoids, can cause gastrointestinal issues, cardiovascular risks, and other systemic side effects. These treatments aim to alleviate pain and improve function but come with potential complications that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved various hip replacement implants for the treatment of hip osteoarthritis, including femoral stems similar to the ACTIS Femoral Stem. These implants are designed to replace the damaged hip joint, providing pain relief and improved mobility. Commonly used materials for these implants include metal alloys, ceramics, and polyethylene. While specific drug approvals related to hip osteoarthritis treatment are not detailed, nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics are commonly used to manage pain and inflammation associated with the condition.

What other types of research exist?

Promising, novel alternatives to the ACTIS Femoral Stem for hip osteoarthritis patients include the Proxima short stem implant by DePuy (J&J) and the new-generation short anatomical femoral stem by Medacta. Both have shown success in clinical outcomes and improving patient functionality and quality of life.

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Hip Stem

ACTIS Hip Stem for Hip Osteoarthritis

N/A

Waitlist Available

Led By Thomas Turgeon, MD

Research Sponsored by Canadian Radiostereometric Analysis Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty

Aged 21 years or older

Must not have

Multi-level lumbar spine fusion

Skin condition on the area of incision

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed for ACTIS itself, typical risks associated with hip replacement may include pain at the site, infection risk post-surgery, blood clots, dislocation of the implant and possible need for revision surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need a hip replacement due to severe arthritis pain.

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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have or had an infection.

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I have had a bone-shortening surgery in my thigh bone.

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I have been diagnosed with ankylosing spondylitis.

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I have had hip surgery that involved putting in metal parts.

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I cannot undergo major surgery due to my health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Subsidence of the ACTIS femoral stem

Secondary study objectives

Comparison of migration per surgical approach

European Quality of Life (EQ-5D-5L) questionnaire

Oxford Hip Score (OHS)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ACTIS hip stemExperimental Treatment1 Intervention

All participants will receive the ACTIS hip stem.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Hip Osteoarthritis (OA) include nonsteroidal anti-inflammatory drugs (NSAIDs) and surgical interventions like hip replacement. NSAIDs work by inhibiting cyclooxygenase enzymes, thereby reducing inflammation and pain. Surgical treatments, such as the use of the ACTIS Femoral Stem in hip replacement, involve replacing the damaged hip joint with a prosthesis to restore function and alleviate pain. This is crucial for Hip OA patients as NSAIDs provide symptomatic relief, while hip replacement offers a more definitive solution by addressing the structural damage in the joint.