Back to resultsNon-weight Bearing in Hip Joint With Accompanying Joint Pain Might Not Progress Radiographic OA
Primary Purpose
Hip OA
Status
Recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
To MRI-detecting bone signal changes in radiographic hip OA
Sponsored by
About this trial
This is an interventional diagnostic trial for Hip OA
Eligibility Criteria
Inclusion Criteria:
- Hip OA, Joint pain
Exclusion Criteria:
- Obvious radipgraphic fracture in hip joint,
Sites / Locations
- Yukio NakamuraRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bone Signal Changes
Arm Description
Outcomes
Primary Outcome Measures
Bone Signal Changes on the Hip MRI
Secondary Outcome Measures
Full Information
NCT ID
NCT02329093
First Posted
December 21, 2014
Last Updated
September 20, 2021
Sponsor
Shinshu University
1. Study Identification
Unique Protocol Identification Number
NCT02329093
Brief Title
Non-weight Bearing in Hip Joint With Accompanying Joint Pain Might Not Progress Radiographic OA
Official Title
Non-weight Bearing in Hip Joint With Accompanying Joint Pain Might Not Progress Radiographic OA
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shinshu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip OA
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bone Signal Changes
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
To MRI-detecting bone signal changes in radiographic hip OA
Intervention Description
To examine whether or not non-weight bearing reduced OA progression
Primary Outcome Measure Information:
Title
Bone Signal Changes on the Hip MRI
Time Frame
1 - 2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Hip OA, Joint pain
Exclusion Criteria:
Obvious radipgraphic fracture in hip joint,
Facility Information:
Facility Name
Yukio Nakamura
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
3908621
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yukio Nakamura, MD, PhD
Phone
+81-263-37-2659
Email
yxn14@aol.jp
First Name & Middle Initial & Last Name & Degree
Yukio Nakamura, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Non-weight Bearing in Hip Joint With Accompanying Joint Pain Might Not Progress Radiographic OA
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