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

NCT07772271 | Completed

• 1 other identifier: 11; 16/12/2020
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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.
2. 2.EXPECTED BENEFIT(S) Determining which type of locking is more advantageous in AO type 31A2 fractures and contributing to the literature.
3. 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. 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. 5.PREGNANCY Pregnant individuals are excluded from the study.
6. 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. 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. 8.COVERAGE OF EXPENSES All examinations, physical checks, and research costs will not be charged to you or any official/private institution.
9. 9.FINANCIAL COMPENSATION You will not receive any payment for participating. Travel expenses will be covered if necessary.
10. 10.CONTACT FOR ISSUES
11. 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. 12.VOLUNTARY PARTICIPATION AND WITHDRAWAL RIGHTS
13. 13.I am participating voluntarily without any pressure.
14. 14.I was informed of my right to refuse participation.
15. 15.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.
16. 16.The researcher or sponsor may remove me from the study without my consent due to non-compliance or to enhance my medical care quality.
17. 17.CONFIDENTIALITY Results may be presented in scientific meetings or publications, but my identity will be kept strictly confidential.
18. 18.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.

Conditions

Intertrochanteric Femur Fracture

Keywords

Intertrochanteric Femur Fracture; AO/OTA 31A2; Distal Interlocking

Outcome Measures

Primary Outcomes (1)

• Postoperative Thigh Pain

  Evaluation of the presence of localized postoperative thigh pain (ipsilateral lateral or anterolateral thigh) at final follow-up based on standardized patient interview and physical examination.

  From date of surgery until final follow-up, assessed up to 30 months (minimum 24 months)

Secondary Outcomes (1)

• Harris Hip Score (HHS)

  From date of surgery until final follow-up, assessed at 24 months postoperatively

Other Outcomes (3)

• Union and Non-Union Rate

  From date of surgery until final follow-up, assessed up to 30 months

• Distal Cortical Thickening

  From date of surgery until final follow-up, assessed up to 30 month

• Composite Mechanical Complication Rate

  From date of surgery until final follow-up, assessed up to 30 month

Study Arms (2)

Dynamic Distal Interlocking Group

EXPERIMENTAL

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

Procedure: Dynamic Distal Interlocking Intramedullary Nailing

Static Distal Interlocking Group

ACTIVE COMPARATOR

Static Distal Interlocking Intramedullary Nailing'

Procedure: Static Distal Interlocking Intramedullary Nailing

Interventions

Dynamic Distal Interlocking Intramedullary Nailing PROCEDURE

Dynamic Distal Interlocking Intramedullary Nailing'

Dynamic Distal Interlocking Group

Static Distal Interlocking Intramedullary Nailing PROCEDURE

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

Static Distal Interlocking Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years and older.
• Radiographically confirmed AO/OTA 31A2 intertrochanteric femur fracture.
• Treated with the same proximal femoral nail system.
• Availability for postoperative clinical and radiographic follow-up.

You may not qualify if:

• Pathological fractures.
• Polytrauma.
• Previous surgery on the ipsilateral hip or femur.
• Incomplete baseline radiographic data.
• Follow-up shorter than 24 months.
• \*Death before the final follow-up.
• Incomplete final clinical or radiographic outcome data.

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir City Hospital

Izmir, İzmir, 35170, Turkey (Türkiye)

Location

Study Officials

• Melikşah U Uzakgider, M.D.

  Izmir City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 19, 2026
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: July 1, 2026
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)