| 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
|
|
|
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
|
|
|
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. |