Collarless Actis hip stem for cementless hip replacement in Asian patients
Official title: Prospective Cohort Study of Primary Cementless Total Hip Arthroplasty Using Actis Stems
Run by Seoul National University Bundang Hospital · NCT07828080 · Data updated 2026-11-12
This study tests how well a collarless Actis hip stem works in adults undergoing primary hip replacement, focusing on outcomes over five years in an East Asian population.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Status | Recruiting |
| Started | June 18, 2025 |
| Main results expected | June 30, 2031 |
| Study ends | December 31, 2031 |
| Registry record updated | September 18, 2026 |
| Trial ID | NCT07828080 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older scheduled for primary total hip arthroplasty using the collarless Actis stem for specified hip conditions.
✕Probably not a fit
Patients who have contraindications to ceramic bearings, non-collarless stems, or who experience complications unrelated to the stem may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective cohort examines the collarless Actis cementless femoral stem used in total hip arthroplasty with ceramic-on-ceramic bearings. All surgeries use a standardized posterior approach and a coordinated cup positioning strategy to optimize fixation and load distribution. Outcomes will track safety and function over five years, with emphasis on bone remodeling and potential stress shielding. The study targets adults undergoing primary hip replacement for arthritis, avascular necrosis, dysplasia, rheumatoid disease, or prior fractures, and excludes those receiving non-Actis stems or cemented components. Data will come from a single East Asian population at a leading Korean center with international collaboration from Johnson & Johnson Medical Korea.
Why it matters
Potential benefit: If successful, patients may experience reliable implant fixation, favorable bone remodeling, and durable joint function with reduced risk of complications over time.
How similar studies have gone: Previous studies and registry data in Western populations have shown favorable short-term results for collarless Actis stems, but East Asian experience is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Age under 18 years * 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
Where it's running
-
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea Recruiting
Study contacts
- Principal investigator: Young-Kyun Lee, MD — Seoul National University Bundang Hospital
- Study coordinator: Jung-Wee Park, MD
- Email: jwepark@snubh.org
- Phone: 82-31-787-7215
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.