Comparison of Clinical Results of Two Cementless Femoral Stem

NCT ID: NCT04501185

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2026-05-31

Brief Summary

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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

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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

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Osteoarthritis, Hip

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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UTS Stem

The subjects who received UTS Stem in total hip arthroplasty.

total hip arthroplasty

Intervention Type DEVICE

The indication for total hip arthroplasty is mainly osteoarthritis.

UTF-reduced Stem

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

total hip arthroplasty

Intervention Type DEVICE

The indication for total hip arthroplasty is mainly osteoarthritis.

Interventions

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total hip arthroplasty

The indication for total hip arthroplasty is mainly osteoarthritis.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United Orthopedic Corporation

INDUSTRY

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pang-Hsin Hsieh, MD

Role: STUDY_DIRECTOR

Chang Gung Memorial Hospital

Locations

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Joint Reconstruction Division at Chang Gung Memorial Hospital, Linkou

Taoyuan, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Pang-Hsin Hsieh, MD

Role: CONTACT

886-3-3281200

Facility Contacts

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Pang-Hsin Hsieh, MD

Role: primary

886-3-3281200

Other Identifiers

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202000226A3

Identifier Type: -

Identifier Source: org_study_id

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