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

Terminated

• Conditions: Osteoarthritis

• Registration Number: NCT00752271
• Lead Sponsor: National Institute on Aging (NIA)

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Study First Posted: 2008-09-15
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-17
• Last Update Posted: 2009-12-18
• Primary Completion: 2010-05
• Study Completion: 2010-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

NIA Clinical Research Unit; 🇺🇸 Baltimore, Maryland, United States