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

Sponsor
National Institute on Aging (NIA) (NIH)
Overall Status
Terminated
CT.gov ID
NCT00752271
Collaborator
(none)
32
1
24
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    32 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Inflammatory and Biomechanical Contributors to Arthritis Development Following Arthroscopic Meniscectomy
    Study Start Date :
    May 1, 2008
    Anticipated Primary Completion Date :
    May 1, 2010
    Anticipated Study Completion Date :
    May 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      40 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 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)

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00752271
      Other Study ID Numbers:
      • AG0105
      First Posted:
      Sep 15, 2008
      Last Update Posted:
      Dec 18, 2009
      Last Verified:
      Dec 1, 2009
      Keywords provided by , ,
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Dec 18, 2009