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AMS Study: Inflammatory and Biomechanical Contributors to Arthritis Development Following Arthroscopic Meniscectomy

NCT ID: NCT00752271

Last Updated: 2009-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoarthritis

Keywords

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Arthroscopic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

24 adults with meniscal damage for which arthroscopy is clinically indicated

No interventions assigned to this group

2

8 adults who have already undergone meniscal resection to serve as positive controls

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role lead

Responsible Party

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National Institute on Aging

Principal Investigators

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Shari M. Ling, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute on Aging (NIA)

Locations

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NIA Clinical Research Unit

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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. doi: 10.1146/annurev.biochem.72.121801.161747.

Reference Type BACKGROUND
PMID: 15952892 (View on PubMed)

Roos EM. Joint injury causes knee osteoarthritis in young adults. Curr Opin Rheumatol. 2005 Mar;17(2):195-200. doi: 10.1097/01.bor.0000151406.64393.00.

Reference Type BACKGROUND
PMID: 15711235 (View on PubMed)

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. doi: 10.1084/jem.20040463.

Reference Type BACKGROUND
PMID: 15809354 (View on PubMed)

Other Identifiers

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AG0105

Identifier Type: -

Identifier Source: org_study_id