Investigation of Q Angle in Osteoporosis Patients

June 24, 2024 updated by: Songül Bağlan Yentür, Firat University

Investigation of Q Angle and Related Factors in Osteoporosis Patients

Osteoporosis (OP) is a bone disease characterized by reduced bone density and deterioration of bone tissue, leading to an increased risk of fractures. There are no studies evaluating Q angle in patients with OP and Osteopenia (OPN) in the literature. Therefore, the aim of this study was to examine the Q angle in patients diagnosed with OP and OPN and to compare it with patients diagnosed with OA. The study will be carried out by measuring the Q angle measurement with a goniometer. Pain assessment will be done with Visual Analog Scale (VAS). Lower extremity muscle strength will be assessed with the Medical Research Council (MRC) Scale. Foot posture will be assessed with the Foot Posture Index (FPI).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Osteoporosis (OP) is a bone disease characterized by reduced bone density and deterioration of bone tissue, leading to an increased risk of fractures. According to Calis et al; it was found that patients with hip fracture had a significantly higher Q angle compared to patients without hip fracture. According to You et al; contraction of the quadriceps muscles corrects the Q angle, therefore sports that use high amounts of quadriceps (strength) training are associated with lower Q angles due to the pulling effect of the quadriceps muscle. There are no studies evaluating Q angle in patients with OP and Osteopenia (OPN) in the literature. Therefore, the aim of this study was to examine the Q angle in patients diagnosed with OP and OPN and to compare it with patients diagnosed with OA. The study will be carried out by measuring the Q angle measurement with a goniometer. Pain assessment will be done with Visual Analog Scale (VAS). Lower extremity muscle strength will be assessed with the Medical Research Council (MRC) Scale. Foot posture will be assessed with the Foot Posture Index (FPI).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who are willing to participate in the study, being between the ages of 40-65 will be included in the study. Patients who have patellofemoral abnormalities during examination, acute traumatic patellofemoral dislocations, surgical revision around the knee, history of any previous lower extremity surgery and serious trauma will be excluded from the study.

Description

Inclusion Criteria:

  • Be willing to participate in the study.
  • Being between the ages of 40-65.
  • Being a woman.

Exclusion Criteria:

  • Patellofemoral abnormalities during examination.
  • Acute traumatic patellofemoral dislocations
  • Surgical revision around the knee
  • History of any previous lower extremity surgery
  • Serious trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with osteoporosis group
Osteoporosis patients will be evaluated in terms of pain, foot posture, Q angle and lower limbs muscle strength.
Other: Patients with osteoporosis group
Pain, Q angle, muscle strength and foot posture will be evaluated.
Patients with osteoarthritis group
Osteoarthritis patients will be evaluated in terms of pain, foot posture, Q angle and lower limbs muscle strength.
Other: Patients with osteoarthritis group
Osteoarthritis patients will be evaluated in terms of pain, foot posture, Q angle and lower limbs muscle strength.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Q angle assessment
Time Frame: 1 minute
Q angle will be evaluated with goniometer.
1 minute

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain assessment
Time Frame: 1 minute
Pain assessment will be done with the Visual Analog Scale (VAS). This measurement is performed with a chart in which no pain is written on one end and very severe pain is written on the other end.
1 minute
Muscle strength assessment
Time Frame: 2 minutes
Lower extremity muscle strength will be assessed with the Medical Research Council (MRC) Scale. Muscle strength is graded on a scale of 0 to 5 according to muscle tone and ability to resist the force of gravity.
2 minutes
Foot posture assessment
Time Frame: 1 minute
Foot posture will be evaluated with the Foot Posture Index (FPI). API is an easy-to-apply, valid and reliable method that provides information about the degree of pronation and supination of the foot with a single numerical result and evaluates the foot in a multidimensional and comprehensive manner.
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Firat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024/07-33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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