Comparison of Clinical Results of Two Cementless Femoral Stem

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Osteoarthritis, Hip

Treatments: Device: total hip arthroplasty

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04501185

202000226A3

Details and patient eligibility

About

In the present study, two types of cementless femoral stem- UTS Stem and UTF-reduced Stem- were utilized in total hip arthroplasty. Due to the design for proximal femur fixation, both femoral stems could prevent stress shielding around the implant, further preventing osteolysis. The difference between both femoral stems is the length, in which UTS Stem is 20% shorter than UTF-reduced Stem. The clinical outcomes of both femoral stems will be compared. Both femoral stems are expected to have equally good radiologic outcome and clinical performance.

Full description

Total hip arthroplasty (THA) is a common orthopedic procedure aimed at improving joint function and alleviating pain in patients with hip joint degeneration. However, the phenomenon of stress shielding-whereby the mechanical properties of the prosthesis lead to reduced load transmission to the surrounding bone-can compromise long-term outcomes. In particular, uncemented THA designs are susceptible to stress shielding, potentially resulting in bone resorption and implant loosening.

To address this challenge, the study focuses on optimizing femoral stem fixation within the proximal femur in two specific stem designs: the UTS and the UTF reduced stem. These stems are strategically designed to enhance load transfer while minimizing stress shielding effects.

A total of 60 patients who are undergoing total hip arthroplasty at Linkou Chang Gung Memorial Hospital will be recruited, including 30 patients in the "UTS" group and 30 patients in the "UTF-reduced" group.The clinical assessments including Success Rate of prosthesis, Numerical Rating Scale (NRS) for pain, Harris Hip Score (HHS), Medical Outcome Study Short Form-36 (SF-36) and : Dual-energy X-ray absorptiometry (DEXA) scanning for bone mineral density monitoring.

Enrollment: 60 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who receive total hip arthroplasty with either a UTS femoral stem or a UTF-reduced femoral stem after June, 2020
2. Patients who have not received total hip arthroplasty in the past

Exclusion criteria

1. Patients who are unable or unwilling to return for follow-up
2. Patients who suffer from mental disorders

Trial design

60 participants in 2 patient groups

UTS Stem

Description:

The subjects who received UTS Stem in total hip arthroplasty.

Treatment:

Device: total hip arthroplasty

UTF-reduced Stem

Description:

The subjects who received UTF-reduced Stem in total hip arthroplasty.

Treatment:

Device: total hip arthroplasty