Non-weight Bearing in Hip Joint With Accompanying Joint P... | NCT02329093

Studies
Non-weight Bearing in Hip Joint With Accompanying Joint Pain Might Not Progress Radiographic OA

NCT02329093

Sponsor

Shinshu University

Status

Recruiting

Last Update Posted

Sep 21, 2021Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Hip OA

Interventions

To MRI-detecting bone signal changes in radiographic hip OA

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2021Actual

Primary Completion Date

Nov 2023Estimated

Completion Date

Nov 2026Estimated

First Submitted Date

Dec 21, 2014

First Submission Date that Met QC Criteria

Dec 29, 2014

First Posted Date

Dec 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2021

Last Update Posted Date

Sep 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

As we have previously reported, the primary cause of hip OA with accompanying joint pain might be bone alterations which can be microfracture. In order to prove it, it is planned that conservative treatment will be performed on the hip OA patients with accompanying joint pain for the first year. For the second year, if the patients still have joint pain, they will do non-weght bearing walk.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bone Signal Changes	Experimental		Procedure: To MRI-detecting bone signal changes in radiographic hip OA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
To MRI-detecting bone signal changes in radiographic hip OA	Procedure	To examine whether or not non-weight bearing reduced OA progression	Bone Signal Changes

Measure	Description	Time Frame
Bone Signal Changes on the Hip MRI		1 - 2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hip OA, Joint pain

Exclusion Criteria:

Obvious radipgraphic fracture in hip joint,

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yukio Nakamura	Recruiting	Matsumoto	Nagano	3908621	Japan

Condition Browse Module

MeSH Terms

ID	Term
D015207	Osteoarthritis, Hip

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided