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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043074
Receipt No. 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 2021/08/19

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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 Ryo
Middle name
Last name Hasegawa
Organization Smith & Nephew KK
Division name Clinical Affairs
Zip code 105-0011
Address Shiba Park Bildg.A-3F 2-4-1, Shiba-Koen Minatoku, Tokyo
TEL 03-5403-8638
Email Ryo.Hasegawa@smith-nephew.com

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Hasegawa
Organization Smith & Nephew KK
Division name Clinical Affairs
Zip code 105-0011
Address 2 -4-1 Shibakoen,Minatoku,Tokyo
TEL 03-5403-8683
Homepage URL
Email Ryo.Hasegawa@smith-nephew.com

Sponsor
Institute Jilei University Hospital
Institute
Department

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
Email 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 Open public 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
2021 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049177

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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