UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057766 |
|---|---|
| Receipt number | R000065731 |
| Scientific Title | The impact of differences in femoral implant design on the peri-implant bone mineral density, muscle strength, and activity level in total hip replacement surgery |
| Date of disclosure of the study information | 2025/05/03 |
| Last modified on | 2025/11/06 21:47:58 |
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Basic information
Public title
The impact of differences in femoral implant design on the peri-implant bone mineral density, muscle strength, and activity level in total hip replacement surgery
Acronym
EU-SCT1
Scientific Title
The impact of differences in femoral implant design on the peri-implant bone mineral density, muscle strength, and activity level in total hip replacement surgery
Scientific Title:Acronym
EU-SCT1
Region
| Japan |
Condition
Condition
osteoarthritis of the hip
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Total hip arthroplasty (THA) is an important treatment for relieving the pain and restoring range of motion limitations caused by hip osteoarthritis and improving patient's quality of life. With an increasing number of procedures being performed due to the aging population, the design of the femoral implant (stem) has become a focal point as a significant factor influencing postoperative outcomes. This study aims to generate evidence that will improve clinical outcomes following THA. It will achieve this by comparing the effects of the shape and surface treatment of the Insignia stem and the Accolade 2 stem on several key factors: initial fixation and mid-term stability of the stem, stem subsidence, bone response around the femoral stem, changes in bone mineral density in the femur, and clinical evaluation. Furthermore, this study intends to provide valuable information for preoperative planning and stem selection in clinical practice. We anticipate that the analysis of radiological evaluations and clinical indicators from multiple perspectives, through randomized trials, will contribute to further advancements in THA outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the change in periprosthetic bone mineral density, measured quantitatively at 1, 2, and 5 years postoperatively using bone mineral density testing around the stem. This change will be calculated relative to the bone mineral density around the stem measured on the 7th day after THA surgery, and the effect of differences in stem design on these changes in periprosthetic bone mineral density will be compared between the two groups.
Key secondary outcomes
Secondary outcomes will compare the two groups regarding the impact of stem design differences on radiological evaluations (plain radiographs and CT scans) and on pre- and post-operative clinical evaluations, including muscle strength, patient-reported outcomes, activity level, and other relevant factors.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The Insignia Stem utilizes a tapered wedge geometry for fixation within the proximal femur. A key design feature is its substantial proximal volume aimed at maximizing metaphyseal fill in lateral view. The stem incorporates a full hydroxyapatite (HA) coating.
Interventions/Control_2
The Accolade 2 Stem utilizes a tapered wedge geometry for fixation within the proximal femur. A key design feature is its flat shape in lateral view. The stem incorporates a 3D porous coating in proximal part.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1) Undergoing primary unilateral or bilateral (simultaneous or staged) Total Hip Arthroplasty (THA) at Ehime University Hospital.
2) Diagnosis of advanced to end-stage osteoarthritis of the hip, confirmed radiographically.
3) Presence of hip pain causing functional limitations in activities of daily living (ADLs).
4) Suitable candidacy for either the Insignia Stem or the Accolade II Stem, confirmed by pre-operative CT-based 3D templating.
5) Ability and willingness to provide written informed consent.
Key exclusion criteria
1) Patients unable to achieve outdoor ambulation, even with the assistance of walking aids (e.g., canes, walkers).
2) Patients with cognitive impairment precluding informed consent, or those otherwise unable to express intention to participate; additionally, any patient deemed unsuitable for study inclusion by the principal investigator or sub-investigators.
3) Patients diagnosed with osteoarthritis of the hip secondary to infection or trauma, idiopathic osteonecrosis of the femoral head (ONFH), or high-grade developmental dysplasia of the hip (Crowe type III or IV).
4) Patients assessed by the attending physician, based on pre-operative CT planning, as having poor suitability for femoral implant fixation due to anatomical or bone quality concerns.
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Takao |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
791-0295
Address
454 Shitsukawa, Toon, Ehime, 791-0295, Japan
TEL
0899605343
takao.masaki.ti@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Kutsuna |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
791-0295
Address
454 Shitsukawa, Toon, Ehime, 791-0295, Japan
TEL
0899605343
Homepage URL
kutsuna.tatsuhiko.bh@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board,Ehime University Hospital
Address
454 Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2032 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2033 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 03 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065731
