Izmir City Hospital
Izmir, İzmir, 35170, Turkey (Türkiye)
NCT Number: NCT07772271
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.
Looking for future studies?
Notify Me65 year and older
All sexes
Interventional
Not applicable
Izmir, İzmir, 35170, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
*Death before the final follow-up.
Dynamic Distal Interlocking Intramedullary Nailing'
Patients treated with an intramedullary nail using a static distal interlocking configuration.
Time frame: From date of surgery until final follow-up, assessed up to 30 months (minimum 24 months)
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.
Time frame: From date of surgery until final follow-up, assessed at 24 months postoperatively
Assessment of overall hip function using the Harris Hip Score at final follow-up.
Time frame: From date of surgery until final follow-up, assessed up to 30 months
Evaluation of fracture union (bridging callus across at least three cortices and absence of pain during weight bearing) versus non-union (absence of progressive healing by 6 months, persistent fracture line, or implant failure).
Time frame: From date of surgery until final follow-up, assessed up to 30 month
Assessment of new or progressive focal cortical hypertrophy around the distal locking screw or nail tip on serial radiographs.
Time frame: From date of surgery until final follow-up, assessed up to 30 month
Measurement of cephalic lag screw backout, occurrence of peri-implant fractures, and the composite mechanical complication rate defined as the sum of non-union and peri-implant fracture.
Bozyaka Training and Research Hospital
Other
Acronym: Distal Locking
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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