AMS Study: Inflammatory and Biomechanical Contributors to Arthritis Development Following Arthroscopic Meniscectomy - Full Text View

Sponsor:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00752271

Purpose

The purpose of this study is to examine the relationship between muscle activation and heart rate on joint generalized inflammation and arthritis development.

Condition
Osteoarthritis

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Inflammatory and Biomechanical Contributors to Arthritis Development Following Arthroscopic Meniscectomy

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	32
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 24 adults with meniscal damage for which arthroscopy is clinically indicated
2 8 adults who have already undergone meniscal resection to serve as positive controls

Detailed Description:

This study will test the hypothesis that knee trauma (as exemplified by the arthroscopy procedure) causes inflammation that alters muscle activation patterns locally and also disrupts the balance between parasympathetic-sympathetic reflexes. It is hypothesized that these factors contribute to development and progression of knee osteoarthritis.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Orthopedic and arthritis clinics in the Baltimore/Washington DC area

Criteria

Inclusion Criteria:

Age 40 or older
Potential candidate for knee arthroscopy for medial
Meniscal tear confirmed on MRI
Prior meniscal resection at least 1 year prior with a persistent knee effusion
Body mass index between 25-35 kg/m2

Exclusion Criteria:

Knee injury in the 1 month before the initial study evaluation
Knee surgery within 1 year before the initial study evaluation
Pace-maker or defibrillator, 2nd or 3rd degree heart block, or other abnormal rhythms
Current diagnosis of diabetes mellitus, a fasting glucose>100mg/dl or >140 mg/dl 2 hour after a glucose challenge
Current diagnosis of an inflammatory condition (e.g. rheumatoid arthritis, gout, etc)
Untreated thyroid disease
Morbid obesity (body mass index >35)
Neuropathy or nerve damage
Stroke or transient-ischemic attacks (mini-stroke)
Recent diagnosis of congestive heart failure or heart attack
Use of prednisone or chemotherapy, steroid or other joint or ant-inflammatory agents in the past 3 months
Current use of medications that influence heart rate
Cognitive impairment that limits your ability to provide informed consent
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752271

Locations

United States, Maryland
NIA Clinical Research Unit
Baltimore, Maryland, United States, 21225

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Shari M. Ling, MD

National Institute on Aging (NIA)

More Information

Publications:

Handel TM, Johnson Z, Crown SE, Lau EK, Proudfoot AE. Regulation of protein function by glycosaminoglycans--as exemplified by chemokines. Annu Rev Biochem. 2005;74:385-410. Review.

Roos EM. Joint injury causes knee osteoarthritis in young adults. Curr Opin Rheumatol. 2005 Mar;17(2):195-200. Review.

Saeed RW, Varma S, Peng-Nemeroff T, Sherry B, Balakhaneh D, Huston J, Tracey KJ, Al-Abed Y, Metz CN. Cholinergic stimulation blocks endothelial cell activation and leukocyte recruitment during inflammation. J Exp Med. 2005 Apr 4;201(7):1113-23.

Responsible Party:	National Institute on Aging ( Shari M. Ling, MD )
Study ID Numbers:	AG0105
Study First Received:	September 11, 2008
Last Updated:	December 17, 2009
ClinicalTrials.gov Identifier:	NCT00752271 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Arthroscopic

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 08, 2010