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临床试验/NCT07828080
NCT07828080招募中不适用

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

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2025年6月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
210
试验地点
1
主要终点
Incidence of orthopedic complications

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Collarless Actis femoral stem (Device)

结局指标

主要结局

Incidence of orthopedic complications

时间窗: 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.

次要结局

  • 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)
  • University of California Los Angeles (UCLA) activity score(Preoperatively and at 1, 2, 3, 4, and 5 years after surgery)
  • Forgotten Joint Score (FJS)(1, 2, 3, 4, and 5 years after surgery)
  • Radiographic findings(6 weeks to 5 years after surgery)
  • Incidence of medical complications(Up to 5 years after the index total hip arthroplasty)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Young-Kyun Lee

Professor

Seoul National University Bundang Hospital

研究点 (1)

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