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

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: Completed
• Conditions: Femur Intertrochanteric Fractures
• Intervention / Treatment: Procedure: Group 1; Procedure: Group 2

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: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
demographic datas	Descriptive statistical data	August 2018
comparison of groups	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	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	age (year)	At the beginning of the study
comparison of groups	Vit D (microgram\L)	before surgery
comparison of groups	Complication (cut out, Z effect, infection, implant failure)	august 2022
comparison of groups	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	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

• Sponsor: Kahramanmaras Sutcu Imam University
• Investigators: Study Chair: Ökkeş Bilal, 3., Assistant researcher

Publications and helpful links

General Publications

• Kucukdeveci AA, Yavuzer G, Tennant A, Suldur N, Sonel B, Arasil T. Adaptation of the modified Barthel Index for use in physical medicine and rehabilitation in Turkey. Scand J Rehabil Med. 2000 Jun;32(2):87-92.
• Jensen JS. Classification of trochanteric fractures. Acta Orthop Scand. 1980 Oct;51(5):803-10. doi: 10.3109/17453678008990877.

Helpful Links

• Barthel index
• Fracture classification

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: weight bearing; intertrochanteric fracture; elderly fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID 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