OsteoarthritisNCT00752271
AMS Study: Inflammatory and Biomechanical Contributors to Arthritis Development Following Arthroscopic Meniscectomy
An observational study of Osteoarthritis, run by National Institute on Aging (NIA) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Orthopedic and arthritis clinics in the Baltimore/Washington DC area
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NIA Clinical Research Unit
Baltimore, Maryland, 21225
About this study
Official title: Inflammatory and Biomechanical Contributors to Arthritis Development Following Arthroscopic Meniscectomy
The purpose of this study is to examine the relationship between muscle activation and heart rate on joint generalized inflammation and arthritis development.
Read the 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.
- Conditions
- Osteoarthritis
- Keywords
- Arthroscopic
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Shari M. Ling, MD, Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752271
- Sponsor's protocol ID
- AG0105
- Status last verified
- Dec 2009
- First submitted
- 11 Sep 2008
- Last updated
- 18 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15952892Roos 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.
PubMed 15711235Saeed 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.
PubMed 15809354
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory and Biomechanical Contributors to Arthritis Development Following Arthroscopic Meniscectomy
- ClinicalTrials.gov ID
- NCT00752271
- Acronym / sponsor ID
- AG0105
- Conditions
- Osteoarthritis
- Keywords
- Arthroscopic
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- May 2008
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 15 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Orthopedic and arthritis clinics in the Baltimore/Washington DC area
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2009.
- Background: PubMed 15952892Handel 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.
- Background: PubMed 15711235Roos 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.
- Background: PubMed 15809354Saeed 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shari M. Ling, MD principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00752271, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2009.