| CTRI Number |
CTRI/2024/11/076612 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study between surgical TENS treatment versus and conservative figure of 8 bandage treatment in mid clavicle fracture |
|
Scientific Title of Study
|
STUDY OF FUNCTIONAL OUTCOME OF OPERATIVE -TITANIUM ELASTIC NAILING SYSTEM (TENS) VERSUS NON-OPERATIVE FIGURE OF 8 BANDAGE TREATMENT FOR ALLMAN GROUP I DISPLACED MIDDLE ONE-THIRD CLAVICLE FRACTURE – A RANDOMIZED CONTROL STUDY SYSTEM (TENS) VERSUS NON-OPERATIVE FIGURE OF 8 BANDAGE TREATMENT FOR ALLMAN GROUP I DISPLACED MIDDLE ONE-THIRD CLAVICLE FRACTURE- A RANDOMIZED CONTROL STUDY |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Viswanathan V |
| Designation |
post gratuate |
| Affiliation |
|
| Address |
OPD 6 , Indira Ghandhi medical college and reasearch institute ,Kathirkamam
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9952165312 |
| Fax |
|
| Email |
visun3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VISWANATHAN V |
| Designation |
post gratuate |
| Affiliation |
INDIRA GANDHI MEDICAL COLLEGE AND REASEARCH INSTITUTE |
| Address |
OPD 6 , INDIRA GHANDHI MEDICAL COLLEGE AND REASEARCH INSTITUTE ,kathirkamam
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9952165312 |
| Fax |
|
| Email |
visun3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Viswanathan V |
| Designation |
post gratuate |
| Affiliation |
|
| Address |
OPD 6 , Indira Ghandhi medical college and reasearch institute ,Kathirkamam
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9952165312 |
| Fax |
|
| Email |
visun3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of orthopaedics , Indira Gandhi medical College and reasearch institute, kathirkamam, Puducherry, India -605009 |
|
|
Primary Sponsor
|
| Name |
Department of Orthopaedics |
| Address |
Indira Ghandhi medical college and reasearch institute ,Kathirkamam |
| Type of Sponsor |
Government medical college |
|
|
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 Ravikumar N |
Indira Ghandhi medical college and reaserch institute |
Department of othopaedics , OPD 6 , Indira Ghandhi medical college and reasearch institute ,Kathirkamam
Pondicherry
PONDICHERRY |
7598500694
amurfriend2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Commitee , Indira Ghandhi medical college and reaserch institue |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S420||Fracture of clavicle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conservaive figure of 8 bandage |
For patients assigned to conservative treatment, follow-up started at the day of inclusion. During the first 2 weeks, patients used a sling and were advised to perform non-weight-bearing pendulum exercises after instruction by a physiotherapist, followed by more active movement up to the horizontal plane. After 6 weeks, full range of motion was permitted and strengthening exercises were started. After treatment, radiological assessments will be assessed immediately after figure of bandage application, two weeks, six weeks and six months and functional assessment will be done after six weeks, three months, six months. |
| Intervention |
Oprative TENS treatment |
Patients assigned to operative treatment had the operation within 3 weeks after injury. Follow-up started on the day of the operation. The postoperative mobilization protocol was the same as for conservative treated patients. After treatment, radiological assessments will be assessed on POD one, two weeks, six weeks and six months and functional assessment will be done after six weeks, three months, six months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Simple closed displaced middle one third clavicle fractures
• Comminuted fracture mid-shaft clavicle. |
|
| ExclusionCriteria |
| Details |
• Compound fractures of clavicle
• Pathological fractures
• Patient with hemiparesis on the affected side
• Associated rib fracture in the affected side
• Associated pneumothorax
• Bilateral clavicle fracture
• Associated scapular fracture
• Known immuno-deficiencies
• Old malunions and non-unions of clavicle
• Associated with neurovascular injury
• Patients with head injury |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Operative TENS treatment is better than conservative figure of 8 bandage treatment |
Outcome assessed in 2 weeks, 6 weeks, 3months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Figure of 8 bandage treatment is better than conservative operative TENS treatment |
Outcome assessed in 2 weeks, 6 weeks,3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/11/2024 |
| Date of Study Completion (India) |
31/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Clavicle is the only vertical long bone that connects thorax and shoulder griddle and helps in free movement around the shoulder joint . 4-12% of all the fractures of the body contributed by clavicle and among that 80% is only by mid shaft clavicle fracture . Traditionally, most of the mid clavicle fractures are managed conservatively by using figure of 8 bandage and arm sling. It has a advantage of being non-invasive and there is no exposure to anaesthesia. Conservative management has a risk of non-union, residual deformity and higher patient dissatisfaction as it need regular adjustment and regular fallow up but still most of the mid clavicle fractures managed conservatively without any serious consequences . Recent study shows there is a increasing trend of surgical management for mid clavicle fractures due to higher malunion rate 15 % and patients dissatisfaction rate of 31 % . Most commonly used surgical methods for management of mid clavicle fracture are plating and intramedullary nailing with TENS. Both these methods showed superior functional results compared to non-conservative treatment. Compared to plating TENS has a benefit of minimally invasive with good cosmetic result and aim at exact restoration of length and early return to activity |