Clinical Outcomes of Primary Cementless Total Hip Arthroplasty Using the Collarless Actis Stem

Condition(s) studied

Investigational drug(s) / intervention(s)

Collarless Actis femoral stem: Primary cementless total hip arthroplasty using the collarless Actis femoral stem and Pinnacle acetabular cup (DePuy Synthes, Warsaw, IN, USA) with a fourth-generation BIOLOX delta ceramic head and liner (CeramTec, Plochingen, Germany).

Study summary

This study looks at how well a hip replacement using the collarless Actis stem works over five years.

Total hip replacement is a common operation for people whose hip joint has been damaged by arthritis, by loss of blood supply to the hip bone, or by a broken hip. During the operation, the damaged parts of the hip are replaced with artificial parts. The Actis stem is the part that is fitted into the thigh bone. It is designed to bond directly with the bone, without the use of bone cement.

The Actis stem is already used in many countries, and early results have been good. However, almost all of those results come from Western patients, and most studies used a version of the stem that has a small collar. Very little is known about how the collarless version performs in Asian patients, who tend to be younger at the time of surgery and more often have the operation because of loss of blood supply to the hip bone.

People aged 18 years or older who are already scheduled for a hip replacement at this hospital may take part. Everyone who takes part has the same operation, with the same set of artificial parts. No extra tests are done for research purposes.

After surgery, participants return to the clinic at 6 weeks, 3 months, and 12 months, and then once a year until 5 years have passed. These are the same visits that patients would have anyway. At each visit, the study team checks for any problems with the new hip, takes routine X-rays, and asks participants to fill in questionnaires about their hip pain, their daily activities, and their overall health.

The main question the study asks is how many participants have a problem with the new hip within five years, such as the hip coming out of place, an infection, a break in the bone around the implant, or the implant becoming loose.

Eligibility

Primary outcome measure(s)

• Incidence of orthopedic complications — Up to 5 years after the index total hip arthroplasty
  Number of participants with any orthopedic complication, defined as dislocation, periprosthetic joint infection, aseptic loosening, or periprosthetic fracture.

Trial sites (1)

More Seoul National University Bundang Hospital trials in South Korea

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