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

Osteoarthritis Clinical Trial

Official title:

Inflammatory and Biomechanical Contributors to Arthritis Development Following Arthroscopic Meniscectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00752271
• Other study ID #: AG0105
• Status: Terminated
• Phase: N/A
• First received: September 11, 2008
• Last updated: December 17, 2009
• Start date: May 2008
• Est. completion date: May 2010

Study information

• Verified date: December 2009
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
United States	NIA Clinical Research Unit	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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