Dynamic Versus Static Distal Interlocking In AO/OTA 31A2 Intertrochanteric Femur Fractures: A Prospective Randomized Controlled Trial

Summary

1. INFORMATION ABOUT THE RESEARCH Title of the Research: Comparison of radiological and functional outcomes of static and dynamic locking in AO type 31A2 trochanteric fractures treated with PFN.

Content: Investigating and comparing the effects of dynamic versus static locking on radiological and functional outcomes in AO Type 31A2 trochanteric fractures treated with Proximal Femoral Nail (PFN).

Aim: AO type 31A2 fractures are unstable, and PFN is predominantly preferred for their surgery. There is no absolute consensus on the locking style of these nails. This study aims to comparatively evaluate the effects of static and dynamic locking on radiological and functional outcomes.

Estimated Duration: 6 months.

Expected Number of Volunteers: Approximately 100 patients applying within 6 months.

Procedures and Treatment: Prospective randomization.
2. EXPECTED BENEFIT(S) Determining which type of locking is more advantageous in AO type 31A2 fractures and contributing to the literature.
3. RISKS AND DISCOMFORTS Both dynamic and static locking are successfully applied in AO type 31A2 fractures. There is no extra risk or discomfort for patients related to this study.
4. MEDICAL BENEFITS FOR VOLUNTEERS The treatment applied in this study may keep your condition under control, or help diagnose your condition using the data obtained. Additionally, the results may be used for the benefit of others.
5. PREGNANCY Pregnant individuals are excluded from the study.
6. ALTERNATIVE TREATMENTS Patients will be randomly assigned to dynamic or static locking. I have learned that other appropriate methods exist for my condition aside from the study procedures, but they will not be used here. If I decline to participate, I retain the right to receive those alternative treatments.
7. WITHDRAWAL FROM THE STUDY Your doctor may remove you from the study without your permission if you fail to follow the treatment requirements, disrupt the schedule, become pregnant, experience side effects, or for reasons to increase treatment efficacy.
8. COVERAGE OF EXPENSES All examinations, physical checks, and research costs will not be charged to you or any official/private institution.
9. FINANCIAL COMPENSATION You will not receive any payment for participating. Travel expenses will be covered if necessary.
10. CONTACT FOR ISSUES

For further information or any issues during the study, you can contact the doctor below:

Dr. Fatih IŞIK \| Phone: 0-507 6961679
11. COMPENSATION FOR DAMAGES I have been informed that if I suffer harm due to this study, necessary medical care will be provided by the researcher, and I am insured against any damage (including injury and death) arising from the study procedure, with expenses covered.
12. VOLUNTARY PARTICIPATION AND WITHDRAWAL RIGHTS

1. I am participating voluntarily without any pressure.
2. I was informed of my right to refuse participation.
3. I can withdraw at any time without giving a reason by notifying the researcher, and this will not affect my current or future medical care.
4. The researcher or sponsor may remove me from the study without my consent due to non-compliance or to enhance my medical care quality.
13. CONFIDENTIALITY Results may be presented in scientific meetings or publications, but my identity will be kept strictly confidential.
14. CONSENT TO PARTICIPATE I have read or had this Informed Consent Form read to me in my native language. The contents were explained verbally and in writing. I had the opportunity to ask questions and received satisfactory answers. By signing, I voluntarily agree to participate without any pressure.

A signed copy of this form has been given to me.

Conditions

• Intertrochanteric Femur Fracture

Interventions

PROCEDURE

Dynamic Distal Interlocking Intramedullary Nailing

Dynamic Distal Interlocking Intramedullary Nailing'

PROCEDURE

Static Distal Interlocking Intramedullary Nailing

Patients treated with an intramedullary nail using a static distal interlocking configuration.

Sponsors & Collaborators

• Bozyaka Training and Research Hospital

  lead OTHER

Principal Investigators

• Melikşah U Uzakgider, M.D. · Izmir City Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2022-09-01

Completion

2026-07-01

Countries

• Turkey (Türkiye)

Study Locations