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OsteoarthritisNCT01031576

Postural Analysis in Patients With Knee Osteoarthritis

An observational study of Osteoarthritis, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Osteoarthritis is the result of the degeneration of the cartilage to articulate, being currently considered as having an multifactorial cause.The knees are one of the affected joints more due to overload that constitutes the main activator or determinative mechanism for the development of the illness. Read more about this study

Who is it for?
Ages 60 to 80 years, women onlyHealthy volunteers can take part
Conditions the study is for
Osteoarthritis
How many people
30 participants
Where
1 siteBrazil
Study dates
Feb 2006to Jun 2009
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 60 to 80 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 15 with diagnosis of OA of knees unilaterally and 15 healthful citizens, both the groups will be of the feminine sex with age between 65 to 75 years

Who may be able to join

  • Clinical diagnosis of Osteoarthritis Disease

Who cannot join

  • Others Disease orthopedics

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Luciano Sencovici

    São Paulo, São Paulo, 04140-080

Other trials in Brazil

About this study

Official title: Postural Analysis and Eletromiographic Activity in Patients With Knee Osteoarthritis

Osteoarthritis is the result of the degeneration of the cartilage to articulate, being currently considered as having an multifactorial cause.The knees are one of the affected joints more due to overload that constitutes the main activator or determinative mechanism for the development of the illness. Beyond pain it has important reduction of the amplitude of movement and the muscular force that causes functional limitation and posture's alterations intervening with the activities of daily life. Therefore, the main objective of this study will be to characterize the posture's alterations and the electromiographic activity in patients with osteoarthritis of knees. For this study 30 citizens will be evaluated, 15 with diagnosis of OA of knees unilaterally and 15 healthful citizens, both the groups will be of the feminine sex with age between 60 to 80 years. The selected patients will answer a questionnaire of personal dates and will have an evaluation fiche, in which will be written down: age, index of corporal mass (IMC), index of Lesquene, index WOMAC (Western Ontario and Mac Master), personal and familiar date of the diagnosis, antecedents, instituted treatments, date of the last x-ray, radiological classification of the osteoarthritis according to Scale of Kellgren, electromiographics date and seeming of the postural evaluation. For the electromiographic evaluation the activity of the muscles vastus lateralis and medial oblique in the isometric contraction maximum volunteer (ICMV) and in the march will be analyzed. And for the postural evaluation will be made three photographs in the sights previous frontal and sagittal right and left, being that, for the analysis of the posturais alterations the program will be used SAPO.

Read the detailed description

Osteoarthritis is the result of the degeneration of the cartilage to articulate, being currently considered as having an multifactorial cause. Of the histological point of view it is characterized for alterations of the loss of the natural viscoelasticity, giving to origin the foci of "softening" in the cartilaginous surface that if gets depressed becoming discontinues for the appearance of "fibrillation zones" provoking reaction of the subcondral bone that if condemns in the pressure areas (sclerosis) and proliferates together to the edges of the joint (osteophytic). It is that affect millions of people annually and one of the main and a common condition causes pain functional incapacity generating enormous economic load for the community. The knees are one of the affected joints more due to overload that constitutes the main activator or determinative mechanism for the development of the illness. Beyond pain it has important reduction of the amplitude of movement and the muscular force that causes functional limitation and posture's alterations intervening with the activities of daily life. Therefore, the main objective of this study will be to characterize the posture's alterations and the electromiographic activity in patients with osteoarthritis of knees. For this study 60 citizens will be evaluated, 30 with diagnosis of OA of knees unilaterally and 30 healthful citizens, both the groups will be of the feminine sex with age between 65 to 75 years. The selected patients will answer a questionnaire of personal dates and will have an evaluation fiche, in which will be written down: age, index of corporal mass (IMC), index of Lesquene, index WOMAC (Western Ontario and Mac Master), personal and familiar date of the diagnosis, antecedents, instituted treatments, date of the last x-ray, radiological classification of the osteoarthritis according to Scale of Kellgren, electromiographics date and seeming of the postural evaluation. For the electromiographic evaluation the activity of the muscles vastus lateralis and medial oblique in the isometric contraction maximum volunteer (ICMV) and in the march will be analyzed. And for the postural evaluation will be made three photographs in the sights previous frontal and sagittal right and left, being that, for the analysis of the posturais alterations the program will be used SAPO (software for postural evaluation - version 0.63).

In the analysis descriptive statistics the average, medium and shunting line will be used standard. The level of significance will be established in α < 0,05.

Conditions
Osteoarthritis
Keywords
Osteoarthritis, posture, knee
Medical subject headings
Osteoarthritis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2009 (estimated)
  2. Study startFeb 2006
  3. Primary completionJun 2008
  4. Study completionJun 2009

Resources

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01031576
Sponsor's protocol ID
12345
Status last verified
Apr 2008
First submitted
2 Apr 2008
Last updated
14 Dec 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis, run by University of Sao Paulo at 1 site in Brazil.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 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 Brazil. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?
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 14 Dec 2009.

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Postural Analysis in Patients With Knee Osteoarthritis | AzTrials