An interventional study of Collarless Actis femoral stem in Osteoarthritis, Hip, Femur Head Necrosis and Femoral Neck Fractures, sponsored by Seoul National University Bundang Hospital. Recruiting at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Treatment
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.
The collarless Actis stem is a cementless femoral component featuring a proximal DUOFIX hydroxyapatite coating and a triple-tapered geometry, intended to enhance proximal bone remodeling, promote favorable load distribution, and limit stress shielding. Favorable short-term outcomes have been reported by the manufacturer and in registry-based analyses, and a comparative series has shown results similar to those of the Corail stem. These data, however, derive almost entirely from Western populations, and the majority of published series have evaluated the collared version of the implant. No study has reported the outcomes of the collarless Actis stem in an East Asian population, in whom osteonecrosis of the femoral head is a more frequent indication for arthroplasty and the mean age at the time of surgery is lower than in Western cohorts.
All participants undergo primary cementless ceramic-on-ceramic total hip arthroplasty using the collarless Actis femoral stem and the Pinnacle acetabular cup, with a fourth-generation BIOLOX delta ceramic head and liner. Hybrid use of implants or ceramic bearings is precluded in order to avoid bias. All procedures are performed through a posterior approach with the patient in the lateral decubitus position. Component positioning follows a combined anteversion technique using anatomical landmarks, with a target cup anteversion of 37.3 degrees minus 0.7 times the stem anteversion.
At the routine preoperative medical clearance, participants are assessed for age, sex, body mass index, ambulatory function graded by the Koval classification, diagnosis, comorbidities, and operative risk according to the American Society of Anesthesiologists classification. Preoperative imaging comprises a three-dimensional computed tomography scan of the hip for planning, together with hip anteroposterior, hip cross-table lateral, pelvis lateral, and lumbosacral spine radiographs. Operative data include operative time, type of anesthesia, estimated blood loss, implant fixation, cup position, intraoperative complications, and length of hospital stay.
Postoperative mobilization begins on the first or second day after surgery, and participants ambulate with partial weight bearing using a walking aid for six weeks. Follow-up is scheduled at 6 weeks, 3 months, and 12 months after surgery and annually thereafter until 5 years, corresponding to the institution's routine postoperative schedule. No additional examinations are performed for research purposes beyond those obtained in routine care.
Serial hip anteroposterior and cross-table lateral radiographs are assessed for implant fixation, ceramic wear, osteolysis, implant loosening, and heterotopic ossification according to previously established criteria. Radiographic evaluation is performed by two independent observers who did not participate in the operations, with the six-week radiographs serving as the baseline for comparison. Patient-reported outcome measures are obtained preoperatively and at one year postoperatively and annually thereafter, and comprise the modified Harris Hip Score, the Hip Disability and Osteoarthritis Outcome Score, the EQ-5D, the University of California Los Angeles activity score, and the Forgotten Joint Score, the last of which is acquired postoperatively only.
The target enrollment of 210 hips was derived from an a priori power analysis. Assuming a complication rate of 6.5 percent, based on the investigators' previously reported 10- to 12-year outcomes of fourth-generation ceramic-on-ceramic total hip arthroplasty using the Pinnacle cup, 178 hips were required to detect a 2 percent difference with 80 percent power at a two-sided alpha of 0.05. Allowing for a 15 percent dropout rate, enrollment was set at 210 hips.
Data are recorded in an electronic case report form using a web-based REDCap platform and are monitored every six months for safety and data quality. Categorical data are summarized as counts and percentages and continuous data as means with standard deviations. Implant survivorship is analyzed using the Kaplan-Meier method with reoperation or revision as the endpoint.
641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.
This study's planned enrollment of 210 is above the median of 90 across 457 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Seoul National University Bundang Hospital is the lead sponsor of 376 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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).
Incidence of orthopedic complications
Number of participants with any orthopedic complication, defined as dislocation, periprosthetic joint infection, aseptic loosening, or periprosthetic fracture.
Time frame: Up to 5 years after the index total hip arthroplasty
Reoperation rate
Number of participants undergoing any reoperation or revision of the index hip for any reason.
Time frame: Up to 5 years after the index total hip arthroplasty
Implant survivorship
Kaplan-Meier survivorship of the implant with reoperation or revision for any reason as the endpoint.
Time frame: Up to 5 years after the index total hip arthroplasty
Modified Harris Hip Score
Modified Harris Hip Score, a measure of hip pain and function ranging from 0 to 100, with higher scores indicating better hip function.
Time frame: Preoperatively and at 1, 2, 3, 4, and 5 years after surgery
Hip Disability and Osteoarthritis Outcome Score (HOOS)
HOOS, a patient-reported measure scored from 0 to 100 in each subscale, with higher scores indicating fewer symptoms and better function.
Time frame: Preoperatively and at 1, 2, 3, 4, and 5 years after surgery
EQ-5D index score
EQ-5D health-related quality of life index, with higher scores indicating better health status.
Time frame: Preoperatively and at 1, 2, 3, 4, and 5 years after surgery
University of California Los Angeles (UCLA) activity score
UCLA activity score, ranging from 1 to 10, with higher scores indicating a higher level of physical activity.
Time frame: Preoperatively and at 1, 2, 3, 4, and 5 years after surgery
Forgotten Joint Score (FJS)
Forgotten Joint Score, ranging from 0 to 100, with higher scores indicating greater ability to forget the artificial joint in everyday life. Acquired postoperatively only.
Time frame: 1, 2, 3, 4, and 5 years after surgery
Radiographic findings
Number of participants with radiographic evidence of implant loosening, osteolysis, ceramic wear, or heterotopic ossification on serial hip anteroposterior and cross-table lateral radiographs, assessed by two independent observers who did not participate in the operations. Six-week radiographs serve as the baseline for comparison.
Time frame: 6 weeks to 5 years after surgery
Incidence of medical complications
Number of participants with deep vein thrombosis, pulmonary embolism, major adverse cardiac events, or death.
Time frame: Up to 5 years after the index total hip arthroplasty
Plan to share: No — 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.
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