Comparison of Clinical Results of Two Cementless Femoral Stem

NCT04501185 | Recruiting FDA Device

• 1 other identifier: 202000226A3
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Hip

Keywords

total hip arthroplasty; total hip replacement; femoral stem

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Radiolucent line

  Change from baseline at 1 year

• Valgus/Varus alignment

  Change from baseline at 1 year

• Morphology of the proximal femur

  at baseline

Study Arms (2)

UTS Stem

The subjects who received UTS Stem in total hip arthroplasty.

Device: total hip arthroplasty

UTF-reduced Stem

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

Device: total hip arthroplasty

Interventions

total hip arthroplasty DEVICE

The indication for total hip arthroplasty is mainly osteoarthritis.

UTF-reduced Stem; UTS Stem

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• United Orthopedic Corporation: collaborator

Study Sites (1)

Joint Reconstruction Division at Chang Gung Memorial Hospital, Linkou

Taoyuan, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Pang-Hsin Hsieh, MD

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Central Study Contacts

Pang-Hsin Hsieh, MD

CONTACT

886-3-3281200; hsieh2634@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 6, 2020
• Study Start: June 1, 2020
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 10, 2023

Record last verified: 2023-09

Locations

TW (1)