UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043074 |
|---|---|
| Receipt number | R000049177 |
| Scientific Title | A Prospective, Multi-Center, Post-Market Clinical Two Year Follow-Up Study that Hydroxyapatite coated stem shows Osseointegration New Evidence using DEXA and Tomosynthesis (HONE study) |
| Date of disclosure of the study information | 2021/01/21 |
| Last modified on | 2025/03/04 16:17:07 |
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Basic information
Public title
A Prospective, Multi-Center, Post-Market Clinical Two Year Follow-Up Study that Hydroxyapatite coated stem shows Osseointegration New Evidence using DEXA and Tomosynthesis (HONE study)
Acronym
A Prospective, Multi-Center, Post-Market Clinical Two Year Follow-Up Study that Hydroxyapatite coated stem shows Osseointegration New Evidence using DEXA and Tomosynthesis (HONE study)
Scientific Title
A Prospective, Multi-Center, Post-Market Clinical Two Year Follow-Up Study that Hydroxyapatite coated stem shows Osseointegration New Evidence using DEXA and Tomosynthesis (HONE study)
Scientific Title:Acronym
A Prospective, Multi-Center, Post-Market Clinical Two Year Follow-Up Study that Hydroxyapatite coated stem shows Osseointegration New Evidence using DEXA and Tomosynthesis (HONE study)
Region
| Japan |
Condition
Condition
Hip joint disease that improves the hip joint function and patients
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate bone mineral density in Gruen zone 7 of the HA coated POLARSTEM two years post-operatively using the POLAR3 Hip System
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate bone mineral density in Gruen zone 7 of the HA coated POLARSTEM two years post-operatively using the POLAR3 Hip System
Key secondary outcomes
To assess perioperative clinical and safety outcomes after Total Hip Arthroplasty (THA) with POLAR3 Hip system:
1 X-ray evaluation (alignment, bone reaction)
2 Tomosynthesis evaluation (bone reaction)
3 Bone mineral density evaluation using Dual-energy X-ray absorptiometry (DEXA)
4 Harris Hip Score (HHS)
5 Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ)
6 Adverse event (AE)
7 Device Deficiency (DD)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Has provided written informed consent for study participation
2 Patients of Japanese descent, of either gender, 20 years of age or older
3 A candidate for total hip arthroplasty (THA) due to NIDJD or any of its composite diagnoses such as osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant
4 Willing and able to comply with study visit schedule including all follow-up visits
5 Has no disease or conditions that in the opinion of the Investigator would compromise the study or would pose a risk due to study participation
Key exclusion criteria
1Acute or chronic infection, local or systemic
2Severe muscle, nerve, or vascular diseases that endanger the extremity
3Has previously received THA in the index joint
4Any of the following conditions in the contralateral joint:
Has received THA as a revision for a failed procedure
Has received THA that is not fully healed and well-functioning in the opinion of the Investigators
5Current diagnosis of immunosuppressive disorder
6History of cancer within 5 years of screening
7Known allergy to any component of the study device
8Conditions known to interfere with THA survival or outcomes including vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal disease, neuromuscular disease
9Current diagnosis of fibromyalgia
10 Mass Index (BMI) over 40
11 Currently enrolled or has participated in a clinical research study (drug, device, or biologic) within 30 days of screening
12Has previously history of femur neck fracture
13Acetabular osteotomy in the index joint
Target sample size
152
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Taguchi |
Organization
Smith & Nephew KK
Division name
Clinical Affairs
Zip code
105-0011
Address
14F, South Wing, World Trade Centre Building, 2-4-1 Hamamatsucho, Minato-ku, Tokyo
TEL
03-5403-8811
Wataru.Taguchi@smith-nephew.com
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Taguchi |
Organization
Smith & Nephew KK
Division name
Clinical Affairs
Zip code
105-5114
Address
14F, South Wing, World Trade Centre Building, 2-4-1 Hamamatsucho, Minato-ku, Tokyo
TEL
03-5403-8811
Homepage URL
Wataru.Taguchi@smith-nephew.com
Sponsor or person
Institute
Jilei University Hospital
Institute
Department
Personal name
Funding Source
Organization
Smith & Nephew KK
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jikei University Hospital
Address
3-19-18 Nishishinbashi, Minatoku, Tokyo
Tel
03-3433-1111
h.fujii@jikei.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
| 2021 | Year | 01 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation Study
Management information
Registered date
| 2021 | Year | 01 | Month | 21 | Day |
Last modified on
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049177
