NCT04501185

Comparison of Clinical Results of Two Cementless Femoral Stem

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Osteoarthritis, Hip

Interventions

Type	Name	Description
DEVICE	total hip arthroplasty	The indication for total hip arthroplasty is mainly osteoarthritis.

Timeline

• Start date: 2020-06-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2020-08-06
• Last updated: 2023-10-10

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study