Partial Weight Bearing Proximal Femoral Nail Due to Intertrochanteric Fracture. (randomized)

November 1, 2022 updated by: Duran Topak, Kahramanmaras Sutcu Imam University

Comparison of Full-Weight and Partial-Weight-Bearing Patient Groups in Patients Over 65 Years of Age Who Underwent Proximal Femoral Nail Due to Intertrochanteric Fracture of the Femur

Femur intertrochanteric fractures (FITC) are one of the most common fractures of the lower extremity, caused by osteoporosis, caused by minor trauma in elderly patients. Today, it is successfully treated with proximal femoral nails (PFN) designed in different ways. After surgical fixation with PFN, patients are mobilized by placing full weight, but some complications can be seen due to the patients being osteoporotic. In this study, the investigators planned to investigate the effect of full weight bearing and partial weight bearing on complications, which were not previously described in the literature.

Study Overview

Status

Status

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

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

Participants over the age of 60 who underwent PFN with the diagnosis of FITK were randomized (double-blinded consecutive full load on one patient and partial weight on one patient), and mobilized a group with full weight with the help of a walker after surgical fixation, and the other group with the help of a walker to give partial weight (balance). We planned to follow up his treatment prospectively. The compatibility of the groups will be evaluated by comparing the bone mineral density, calcium, alkaline phosphatase, phosphate, vitamin D levels and ages of the patients. Fracture types and post-treatment reduction quality of patients in both groups will be compared. We planned to compare the complication rates, Barthel Index and harris hip scores in the follow-up of the patients.

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 (Actual)

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.
133

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

  • Turkey
    • Eyalet/Yerleşke
      • Kahramanmaraş, Eyalet/Yerleşke, Turkey, 46040
        • Duran Topak

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

61 years to 91 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

1. Patients over 65 years of age who underwent proximal femoral nail due to femoral intertrochanteric fracture

Description

Inclusion Criteria:

  1. Patients over 65 years of age with intertrochanteric femoral fractures
  2. Patients treated with proximal femoral nail
  3. Patients able to walk before treatment
  4. Patients who can be contacted

Exclusion Criteria:

  1. Patients without regular follow-up for 1 year
  2. Patients who do not walk before or after fracture
  3. who have a neurological disease
  4. Patients with partial hip replacement after fracture
  5. Patients who cannot be contacted after treatment
  6. Patients who died within 1 year after treatment

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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.
Group 1
weight bearing situation: patients with partial weight bearing after treatment
Procedure: Group 1
Even numbered patients will partial weight bearing after treatment,
Other Names:
  • partial weight bearing
Procedure: Group 2
patients with odd numbers will walk with full weight bearing after treatment
Other Names:
  • full weight bearing
Group 2
weight bearing: patients with full weight bearing after treatment
Procedure: Group 1
Even numbered patients will partial weight bearing after treatment,
Other Names:
  • partial weight bearing
Procedure: Group 2
patients with odd numbers will walk with full weight bearing after treatment
Other Names:
  • full weight bearing

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
demographic datas
Time Frame: August 2018
Descriptive statistical data
August 2018
comparison of groups
Time Frame: 1 year after surgery
harris hip score: The Turkish version of the Harris hip score with adequate internal consistency (Cronbach's alpha, 0.70) and test-retest reliability (ICC = 0.91) was used for functional outcomes. It is evaluated with scores ranging from 0 to 100. The higher the score, the better the hip function.
1 year after surgery
comparison of groups
Time Frame: 6 month after operative treatment
Barthel Index: The Turkish version of the Barthel index, which was developed by Mahoney and Barthel in 1965, and edited by Küçükdeveci et al., was used to evaluate the degree of independence of patients in activities of daily living. In this scale, where the possible score is between 0-100, the high score means that the patient is independent from other people and can run his own business; 0-20 points are defined as fully dependent, 21-61 points severely dependent, 62-90 points moderately dependent, 91-99 points mildly dependent, and 100 points fully independent
6 month after operative treatment
comparison of groups
Time Frame: At the beginning of the study
age (year)
At the beginning of the study
comparison of groups
Time Frame: before surgery
Vit D (microgram\L)
before surgery
comparison of groups
Time Frame: august 2022
Complication (cut out, Z effect, infection, implant failure)
august 2022
comparison of groups
Time Frame: On completion of the study, an average of 1 year
Union time (week): Fracture union was defined radiologically as visible callus formation and reduction in pain in the groin.
On completion of the study, an average of 1 year
comparison of groups
Time Frame: patient's last control date, at least 1 year later
Following time (month): The time elapsed between the date the patient came for the last control and the first application
patient's last control date, at least 1 year later

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.
Kahramanmaras Sutcu Imam University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ökkeş Bilal, 3., Assistant researcher

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

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.
August 1, 2018

Primary Completion (Actual)

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.
March 30, 2021

Study Completion (Actual)

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.
August 30, 2022

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).
October 18, 2022

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.
October 28, 2022

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.
November 1, 2022

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.
November 2, 2022

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.
November 1, 2022

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.
November 1, 2022

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.
  • 13.07.2018\16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patients over the age of 60 who underwent PFN with the diagnosis of FITK were randomized (double-blinded consecutive full load on one patient and partial weight on one patient), and mobilized a group with full weight with the help of a walker after surgical fixation, and the other group with the help of a walker to give partial weight (balance). We planned to follow up his treatment prospectively. The compatibility of the groups will be evaluated by comparing the bone mineral density, calcium, alkaline phosphatase, phosphate, vitamin D levels and ages of the patients. Fracture types and post-treatment reduction quality of patients in both groups will be compared. We planned to compare the complication rates and harris hip scores in the follow-up of the patients.

IPD Sharing Time Frame

5 years

IPD Sharing Access Criteria

for researchers

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings