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CTRI Number  CTRI/2024/08/072665 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 16/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Interlocking Nailing in Shaft of Humerus fracture in patients with 3 Stitch Technique 
Scientific Title of Study   Interlocking Nailing in Shaft of Humerus with Three Stitch Technique 
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 Shashwat Anand 
Designation  Junior resident 
Affiliation  Dy Patil hospital and school of medicine  
Address  Department of orthopaedic, DY Patil school of medicine , Nerul , Navi Mumbai

Mumbai
MAHARASHTRA
400706
India 
Phone  7349494101  
Fax    
Email  drshashwatanand97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sachin kale  
Designation  Professor 
Affiliation  Dy Patil hospital and school of medici 
Address  Department of Orthopaedic , DY Patil school of medicine , Nerul , Navi Mumbai

Mumbai
MAHARASHTRA
400706
India 
Phone  9821431687  
Fax    
Email  sachinkale@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sachin Kale 
Designation  Professor 
Affiliation  Dy Patil hospital and school of medicine  
Address  Department of orthopaedic,Dy Patil school of medicine,Nerul,Navi Mumbai

Mumbai
MAHARASHTRA
400706
India 
Phone  9821431687  
Fax    
Email  sachinkale@gmail.com  
 
Source of Monetary or Material Support  
Dr. D.Y Patil hospital and research centre, Nerul, Navi Mumbai- 400706 
 
Primary Sponsor  
Name  Dr Sachin kale 
Address  Dr DYPATIL school of medicine and hospital, Ayyappa temple road , vidyanagar , sector 5 , Nerul , Navi mumbai 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shashwat Anand   Dr. D. Y. Patil school of medicine and hospital  Department of orthopaedic, 3rd floor, Dr. D. Y. Patil school of medicine and hospital ,ayyappa temple road , Vidya nagar , sector 5 , Mumbai , Maharashtra
Mumbai
MAHARASHTRA 
7349494101

drshashwatanand97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
International ethics committee for biomedical and health research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patient with only humerus fracture 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. All patients giving consent to be part of this study.
2. Patients with history of trauma causing fracture of diaphyseal numeral shaft.
3. Patient showing X ray changes of fracture of diaphyseal humerus shaft.
4. Patient willing and motivated for surgery. 
 
ExclusionCriteria 
Details  Skeletally immature patients
Pathological fractures
Associated radial nerve palsy
Clinically detectable focus of active infection
Not willing for surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of three stitch technique as a surgical modality in treatment of fracture of shaft of humerus  12 weeks post operative period 
 
Secondary Outcome  
Outcome  TimePoints 
To study short term & long term functional outcome after use of interlocking nail for diaphyseal fracture of humerus using three stitch technique   2 , 4 weeks , 3 months 6 months, 1 year post operative period 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   18/09/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
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  

Humeral shaft fractures may be defined as the disruption of the bony cortex along the diaphyseal aspect of the humerus. Fractures of the shaft of the humerus account for 1% to 3% of all fractures and approximately 20% of all fractures involving the bone. There is a bimodal distribution of injury which peaks in the third and seventh decades, with high energy mechanisms for younger populations and low energy mechanisms for the elderly

elderly.

Treatment of these fractures involve both non-surgical and surgical management. N surgical interventions utilised includes shoulder spicas, abduction splints, Velpeau bandages, and Thomas arm splints. Surgical fixation by means of open reduction and internal fixation (ORIF), intramedullary nailing (IM nail) and minimally invasive plate osteosynthesis(MIPO) helps achieve fracture healing and early mobilisation of adjacent joints. Hence, the use of surgical techniques in the fixation of diaphyseal humeral fractures has increased in the last few years.

In open reduction and internal fixation (ORIF), fracture can be visualised using different approaches and a plate with screws is used.

Advantages include direct visualisation of the fracture site and a high probability of anatomic reduction, with absolute stability and direct bone healing. Disadvantages include extensive dissection, iatrogenic injuries, infection, and the possibility of further operation.

Plate osteosynthesis provides rigid fixation and a good functional recovery. However, it requires a wide surgical exposure increasing chances of intra-op complications and more time when compared with intramedullary fixation.

Intramedullary nailing (IM nail) for diaphyseal humeral fractures gained popularity due to the minimal dissection needed and the preservation of the fracture haematoma, utilising relative stability and indirect healing. The disadvantages of IM nails are a higher rate of shoulder pain and re-operation, as well as an increased risk of rotational malignment. Intramedullary nail act as load sharing and stress shielding devices. The most commonly used are the ante grade and retrograde humerus nailing.

However, there have been associated concerns like shoulder impairment due to rotator cuff violation, cartilage damage, proximal nail migration or adhesive capsulitis with the use of ante grade intramedullary nail. Also, the distal locking involves insertion of the antero-posterior screw at the transition zone of the lower third humerus which is difficult and carries a risk of neurovascular injury. Latero-medial locking, on the other hand, can cause injury to the radial or lateral cutaneous nerve.


Retrograde nailing was introduced in order to elude these aforementioned complications and technical difficulties. However, apart from being technically demanding procedure, this technique has pitfalls like posterior cortex comminution due to high nail resistance (due to the triangular geometry of distal the humerus providing less space for the nail insertion) and stiffness of the elbow joint due to the violation of triceps muscle.

So taking into consideration the benefits and disadvantages of various surgical techniques, we have come up with the three stitch technique for ante grade humerus nailing. The goal is to avoid all surgical difficulties and complications encountered during the use of traditional method of antegrade humerus nailing.

 
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