NCT07828080

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
64mo left

Started Jun 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Jun 2025Dec 2031

Study Start

First participant enrolled

June 18, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2031

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

6 years

First QC Date

September 14, 2026

Last Update Submit

September 14, 2026

Conditions

Femur Head NecrosisFemoral Neck FracturesArthritis RheumatoidArthritis, Post-traumaticOsteoarthritis, HipDevelopmental Dysplasia of Hip

Keywords

Total hip arthroplastyCementless femoral stemActis stemCeramic-on-ceramicProspective cohortImplant survivorship

Outcome Measures

Primary Outcomes (1)

  • Incidence of orthopedic complications

    Number of participants with any orthopedic complication, defined as dislocation, periprosthetic joint infection, aseptic loosening, or periprosthetic fracture.

    Up to 5 years after the index total hip arthroplasty

Secondary Outcomes (9)

  • Reoperation rate

    Up to 5 years after the index total hip arthroplasty

  • Implant survivorship

    Up to 5 years after the index total hip arthroplasty

  • Modified Harris Hip Score

    Preoperatively and at 1, 2, 3, 4, and 5 years after surgery

  • Hip Disability and Osteoarthritis Outcome Score (HOOS)

    Preoperatively and at 1, 2, 3, 4, and 5 years after surgery

  • EQ-5D index score

    Preoperatively and at 1, 2, 3, 4, and 5 years after surgery

  • +4 more secondary outcomes

Study Arms (1)

Actis

EXPERIMENTAL

Participants undergo primary cementless total hip arthroplasty using the collarless Actis femoral stem with a Pinnacle acetabular cup and a fourth-generation ceramic-on-ceramic bearing, performed through a posterior approach with the patient in the lateral decubitus position.

Device: Collarless Actis femoral stem

Interventions

Collarless Actis femoral stemDEVICE

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).

Actis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Related Publications (1)

  • Park JW, Kim HS, Kim KC, Lee YK, Ha YC, Koo KH. A 10- to 12-year follow-up study of delta ceramic-on-ceramic total hip arthroplasty. Arch Orthop Trauma Surg. 2023 Aug;143(8):5385-5394. doi: 10.1007/s00402-022-04758-x. Epub 2023 Jan 3.

    PMID: 36595032BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, HipFemur Head NecrosisFemoral Neck FracturesArthritis, RheumatoidHip DislocationArthritis

Condition Hierarchy (Ancestors)

OsteoarthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOsteonecrosisBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsHip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesJoint Dislocations

Study Officials

  • Young-Kyun Lee, MD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Wee Park, MD

CONTACT

82-31-787-7215jwepark@snubh.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2026

First Posted

September 18, 2026

Study Start

June 18, 2025

Primary Completion (Estimated)

June 30, 2031

Study Completion (Estimated)

December 31, 2031

Last Updated

September 18, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data are the property of the sponsor institution and are subject to confidentiality obligations under the research support agreement. There is no plan to share individual participant data.

Locations

KR(1)