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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027594
Receipt No. R000031555
Scientific Title Hydroxyapatite-coated Stem Outcome and Pain Evaluation
Date of disclosure of the study information 2017/07/01
Last modified on 2018/12/13

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Basic information
Public title Hydroxyapatite-coated Stem Outcome and Pain Evaluation
Acronym HOPE Study
Scientific Title Hydroxyapatite-coated Stem Outcome and Pain Evaluation
Scientific Title:Acronym HOPE Study
Region
Japan

Condition
Condition Non-inflammatory degenerative hip joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of pelvis, and diastrophic variant
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Total hip arthroplasty surgery using HA coated stem for Japanese patients and clinical results and X-ray evaluation after 2year of surgery,clearly demonstrate the efficacy and safety of HA coated stem for Japanese patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ) Total Score between baseline and 730 days post-operation.
Key secondary outcomes 1)Cumulative revision rate for each femoral stem at each follow-up visit.
2)Change in Harris Hip Score (HHS) between baseline and each follow-up visit.
3)Change in the 3 dimensions of the JHEQ between baseline and each follow-up visit.
4)Change in pain as measured by the Visual Analogue Scale (VAS) between baseline and each follow-up visit.
5)Changes in EQ-5D-5L and in EQ-5D-5L-derived Quality Adjusted Life Years (QALY) between baseline and each follow-up visit.
6)Radiographic outcomes.
7)Comparison of revision rate, HHS, 3 dimensions and total score of JHEQ, pain, and EQ-5D-5L including QALY between subjects with and without a diagnosis of osteoporosis at each of the follow-up visits.

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 1)Acute or chronic infection, local or systemic.
2)Severe muscle, nerve, or vascular diseases that endanger the extremity.
3)Has previously received THA in the index joint.
4)Any 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 Investigator.
5)Current diagnosis of immunosuppressive disorder.
6)History of cancer within 5 years of screening.
7)Known allergy to any component of the study device.
8)Conditions known to interfere with THA survival or outcomes including vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal disease, neuromuscular disease.
9)Current diagnosis of fibromyalgia.
10)Body Mass Index (BMI) > 40.
11)Currently enrolled or has participated in a clinical research study (drug, device, or biologic) within 30 days of screening.
Target sample size 808

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Ohzono
Organization Amagasaki Chuou Hospital
Division name Orthopedic surgery
Zip code
Address 1-15-6 Amagasai City,Hyogo Pref,660-0893 Japan
TEL 06-6499-3045
Email ohzono@chuoukai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Ide
Organization Smith & nephew KK
Division name Global Clinical Operations
Zip code
Address Shiba Park Bldg.A-3F 2-4-1,Shiba-Koen Minato-ku,Tokyo 105-0011 Japan
TEL 03-5403-8025
Homepage URL
Email takahiro.ide@Smith-Nephew.com

Sponsor
Institute Kansai Rousai 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
Address
Tel
Email

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
2017 Year 07 Month 01 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
2017 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multicenter, prospective, observational, cohort study

Management information
Registered date
2017 Year 06 Month 01 Day
Last modified on
2018 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031555

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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