Clinical trial NCT00752271: AMS Study: Inflammatory and Biomechanical Contributors to Arthritis Development Following Arthroscopic Meniscectomy
Official title: Inflammatory and Biomechanical Contributors to Arthritis Development Following Arthroscopic Meniscectomy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis
Keywords: Arthroscopic
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
First posted: 2008-09-15
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthopedic and arthritis clinics in the Baltimore/Washington DC area

Brief summary: 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: 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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: NIA Clinical Research Unit
state: Maryland
Study officials:
affiliation: National Institute on Aging (NIA)
name: Shari M. Ling, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.