Clinical trial NCT04501185: Comparison of Clinical Results of Two Cementless Femoral Stem
Official title: Comparison of Clinical Results of Two Cementless Femoral Stem
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis, Hip
Keywords: total hip arthroplasty
total hip replacement
femoral stem
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: United Orthopedic Corporation
First posted: 2020-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive total hip arthroplasty with either a UTS femoral stem or a UTF-reduced femoral stem after June, 2020 at Chang Gung Memorial Hospital, Linkou

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Success rate
timeFrame: Duration of 1 year
measure: Numerical Rating Scale
timeFrame: Change from baseline at 1 year
measure: Harris Hip Score
timeFrame: Change from baseline at 1 year
measure: Medical Outcome Study Short Form-36
timeFrame: Change from baseline at 1 year
measure: DEXA scanning
timeFrame: Change from baseline at 1 year
Secondary outcomes:
measure: Radiolucent line
timeFrame: Change from baseline at 1 year
measure: Valgus/Varus alignment
timeFrame: Change from baseline at 1 year
measure: Morphology of the proximal femur
timeFrame: at baseline
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Joint Reconstruction Division at Chang Gung Memorial Hospital, Linkou
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Pang-Hsin Hsieh, MD
role: STUDY_DIRECTOR
References: