| CTRI Number |
CTRI/2025/01/079405 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Single center prospective longitudinal descriptive study |
| Study Design |
Other |
|
Public Title of Study
|
Results of femoral neck system surgery for fracture neck of femur |
|
Scientific Title of Study
|
Clinical and radiological outcome of internal fixation of fracture neck of femur in adults using femoral neck system |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soham Sadekar |
| Designation |
Junior resident |
| Affiliation |
Kasturba Hospital, MAHE, Manipal |
| Address |
Room no.4, Department of Orthopaedics, Kasturba hospital, Manipal, Karnataka 576104
Udupi KARNATAKA 576104 India |
| Phone |
9892786911 |
| Fax |
|
| Email |
sadekarsoham898@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Raghuraj Kundangar |
| Designation |
Associate professor |
| Affiliation |
Kasturba Hospital, MAHE, Manipal |
| Address |
Room no.4, Department of Orthopaedics, Kasturba hospital, Manipal, Karnataka 576104
Udupi KARNATAKA 576104 India |
| Phone |
9880884933 |
| Fax |
|
| Email |
raghuraj.sk@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Soham Sadekar |
| Designation |
Junior resident |
| Affiliation |
Kasturba Hospital, MAHE, Manipal |
| Address |
Room no.4, Department of Orthopaedics, Kasturba hospital, Manipal, Karnataka 576104
KARNATAKA 576104 India |
| Phone |
9892786911 |
| Fax |
|
| Email |
sadekarsoham898@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba hospital, MAHE, Manipal, Udupi, Karnataka , India 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Soham Sadekar |
| Address |
Room no. 4, Department of Orthopaedics, Kasturba hospital, MAHE, Manipal, Karnataka 576104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Soham Sadekar |
Kasturba Hospital, mahe, Manipal |
Room no. 4, Department of Orthopaedics, Kasturba hospital , Manipal, Karnataka 576104 Udupi KARNATAKA |
9892786911
sadekarsoham898@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S720||Fracture of head and neck of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients [aged above 18 years] diagnosed with fracture neck of femur and treated with internal fixation by femoral neck system at Kasturba hospital, Manipal |
|
| ExclusionCriteria |
| Details |
-Patients with other associated lower limb/hip fractures in ipsilateral or contralateral limb
-Patients with diagnosed psychiatric disorders or cognitive dysfunction unable to rpovide accurate history/complains
-Patients with pathological fractures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Fracture union rate(RUSH)
-time to union
-Loss of fixation
-non-unions
-development of Avascular necrosis
-Harris hip score
-Visual analogue scale. |
-Immediate post-op
-6 weeks
-3 months
-6 months
-9 months
-1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Time to union
-Loss of fixation
-non-unions
-development of Avascular necrosis |
-Immediate post op
-6 weeks
-3 months
-6 months
-9 months
-1 year |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Purpose of this study is to assess the results of Femoral neck system in treatment of fracture neck of femur. This study will be conducted from December 2024 to April 2026 and will recruit 50 or more participants. The study will involve analyzing the results of Femoral neck system in fracture neck of femur by observing the progress in patients treated with the same. This will include detailed history taking, clinical examination, study of X-rays of the participants. Femoral neck system is standard of care in fracture neck of femur. All adult patientswithFemur neck fractures planned for Internal fixation with Femoral neck system will be included in this study. Pre-operative clinical assessment will include Recording Harris hip score, Charite mobility index and pain as per visual analogue scale for all patients at presentation. Radiological assessment will include Recording femur neck length and femur neck shaft angles from X-rays at presentation. Post-operative assessment will be done Immediate post-op and at 6 weeks, 3 months, 6 months, 9 months and 1 year follow-ups [The follow up durations are routinely followed as standard of care and not done for purpose of study] which will include Recording Harris hip scores, Charite mobility index and pain. Radiological assessment will include noting Fracture union [RUSH), Non-union, loss of fixation, Avascular necrosis of femoral head. Femoral neck fractures are very common and account for over 50% of all hip fractures. Standard treatment for fracture neck of femur is surgical. The surgical treatment can either be internal fixation or arthroplasty depending on the age of the patient. The novel technique of FNS developed in 2018 is a relatively minimally invasive procedure which reduces blood loss and infection risk. Biomechanical studies have shown axial and rotational stability, operative time, union rates and stability of FNS are similar to other surgical options while being superior in terms of intraoperative blood loss, non- union, internal fixation failure and betterment of Harris hip scores. There are few reports discussing clinical implementation of FNS out of which most are retrospective in nature and include a small cluster of patients. Intra-operative and Post-operative parameters of FNS have not been fully explored. This study will increase the available data on femoral neck system surgery and may provide more clarity on its outcomes. It will also help in validating the previous studies done by reproducing the results.
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