Comparison of Clinical Results of Two Cementless Femoral Stem

Osteoarthritis, Hip Clinical Trial

Official title:

Comparison of Clinical Results of Two Cementless Femoral Stem

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04501185
• Other study ID #: 202000226A3
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: May 2026

Study information

• Verified date: September 2023
• Source: Chang Gung Memorial Hospital
• Contact: Pang-Hsin Hsieh, MD
• Phone: 886-3-3281200
• Email: hsieh2634[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Device:
• total hip arthroplasty
The indication for total hip arthroplasty is mainly osteoarthritis.

Locations

Country	Name	City	State
Taiwan	Joint Reconstruction Division at Chang Gung Memorial Hospital, Linkou	Taoyuan City

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	United Orthopedic Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate	Failure is defined as removal or revision of any components as a result of mechanical failure or complications.; Sucess is defined as implants that are sucessfully implanted without any failure for the duration of 1 year.; The success rate will be represented as a percentage (%).	Duration of 1 year
Primary	Numerical Rating Scale	Numerical Rating Scale is a patient-reported outcome measure. The scale ranges from 0 to 10. A score of 0 represents no pain, while a score of 10 represents extreme pain.	Change from baseline at 1 year
Primary	Harris Hip Score	Harris Hip Score includes 4 sections that evaluate pain, function, deformity, and range of motion. Total scores is from 0 to 100, higher scores represent a better outcome.	Change from baseline at 1 year
Primary	Medical Outcome Study Short Form-36	SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. It consists of two sections, physical component summary and mental component summary, with 36 items in total.	Change from baseline at 1 year
Primary	DEXA scanning	DEXA scanning is used to monitor and quantify bone mineral density, which helps to understand if the implant has an effect on the change of bone mineral density.	Change from baseline at 1 year
Secondary	Radiolucent line	Radiologic analysis helps observe the existence of radiolucent lines, which can be analyzed to determine if implant loosening occurs.	Change from baseline at 1 year
Secondary	Valgus/Varus alignment	Radiologic analysis helps measure the degree of the alignment of the hip.	Change from baseline at 1 year
Secondary	Morphology of the proximal femur	Morphology of the proximal femur was classified using Dorr Type.	at baseline