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NCT07828080Recruiting

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

Prospective Cohort Study of Primary Cementless Total Hip Arthroplasty Using Actis Stems

Source: ClinicalTrials.gov · Last updated 18 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
210 (estimated)
First submitted
14 Sept 2026
Start date
Jun 2025
Primary completion date
Jun 2031
Lead sponsor
Seoul National University Bundang Hospital
NCT number
NCT07828080

What you commit to

  • Study type: Interventional
  • Planned participants: 210
  • From Jun 2025 to the primary completion date, Jun 2031
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Age under 18 years

Other

  • Total hip arthroplasty performed with a femoral stem other than the collarless Actis stem
  • Severe medical comorbidity precluding participation
  • Unwilling to participate in the study

Who the study is looking for

  • Age 18 years or older
  • Scheduled to undergo primary total hip arthroplasty for one of the following: osteoarthritis of the hip, developmental dysplasia of the hip, rheumatoid arthritis, non-rheumatoid inflammatory arthritis, post-traumatic arthritis, osteonecrosis of the femoral head, or displaced femoral neck fracture
  • Willing and able to provide written informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Seoul National University Bundang Hospital
Coordinator of this site? Confirm its status
Seongnam-siSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.