Osteoarthritis: Weakness From Inflammation | NCT00104312

Studies
Osteoarthritis: Weakness From Inflammation

NCT00104312

Sponsor

National Institute on Aging (NIA)

Status

Completed

Last Update Posted

May 29, 2009Estimated

Enrollment

88Estimated

Phase

Not provided

Conditions

Osteoarthritis

Interventions

Not provided

Countries

United States

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

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2001

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Feb 24, 2005

First Submission Date that Met QC Criteria

Feb 24, 2005

First Posted Date

Feb 25, 2005Estimated

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

May 28, 2009

Last Update Posted Date

May 29, 2009Estimated

Description Module

Brief Summary

The purpose of this study is to understand the factors that lead to muscle weakness with arthritis and aging.

Detailed Description

Through this study, we hope to learn about the natural history of knee osteoarthritis and the disability that arises from it. We hope to better understand why people with knee osteoarthritis develop difficulty with mobility (e.g. walking, standing) in hopes of finding a cure.

This study requires 1 four-hour visit to Harbor Hospital. The visit involves a physical exam, a DEXA bone density scan, blood and urine testing, knee x-rays, strength testing and a surface electromyography (EMG). Samples of muscle, joint fluid and joint tissue will be collected during your planned surgery.

Participation in this study is entirely voluntary.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

88Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Participants with symptomatic knee osteoarthritis
2		Participants without symptomatic knee osteoarthritis, age-matched as controls

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

50 years of age or older
Normal body weight (a Body Mass Index (BMI) of 30 or less)
Osteoarthritis of the knee (prior to knee surgery)
Planning to have knee surgery at a MedStar Hospital

Exclusion Criteria:

History of a stroke
History of muscle weakness or paralysis
History of Rheumatoid Arthritis or
Inflammatory Joint Disease
History of a Bleeding Disorder
History of Gout
Diabetes for which you take insulin
Polymyalgia rheumatica (total body muscle aching/stiffness)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Community - Men and women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shari Ling, MD	NIA, Johns Hopkins Medical Institution Divisions of Rheumatology, Gerontology, and Geriatrics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Harbor Hospital		Baltimore	Maryland	21225	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10817551	Background	Cooper C, Snow S, McAlindon TE, Kellingray S, Stuart B, Coggon D, Dieppe PA. Risk factors for the incidence and progression of radiographic knee osteoarthritis. Arthritis Rheum. 2000 May;43(5):995-1000. doi: 10.1002/1529-0131(200005)43:53.0.CO;2-1.
9811049	Background	Slemenda C, Heilman DK, Brandt KD, Katz BP, Mazzuca SA, Braunstein EM, Byrd D. Reduced quadriceps strength relative to body weight: a risk factor for knee osteoarthritis in women? Arthritis Rheum. 1998 Nov;41(11):1951-9. doi: 10.1002/1529-0131(199811)41:113.0.CO;2-9.

ID	Term
D010003	Osteoarthritis
D020370	Osteoarthritis, Knee

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases