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CTRI Number  CTRI/2026/03/105216 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 01/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Does cutting or preserving the ankle ligament during heel fracture surgery improve recovery. 
Scientific Title of Study   Impact of calcaneofibular ligament sectioning versus preservation during surgery on outcomes of displaced intra-articular calcaneal fractures: A Preliminary 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  Dr Shivam Mittal 
Designation  Junior resident 
Affiliation  AIIMS , New Delhi 
Address  Department of orthopaedics, AIIMS New Delhi

South
DELHI
110029
India 
Phone  7374040028  
Fax    
Email  mittalsh16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivam Mittal 
Designation  Junior resident 
Affiliation  AIIMS , New Delhi 
Address  Department of orthopaedics, AIIMS New Delhi

South
DELHI
110029
India 
Phone  7374040028  
Fax    
Email  mittalsh16@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shivam Mittal 
Designation  Junior resident 
Affiliation  AIIMS , New Delhi 
Address  Department of orthopaedics, AIIMS New Delhi

South
DELHI
110029
India 
Phone  7374040028  
Fax    
Email  mittalsh16@gmail.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi, India PIN Code : 110029 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Office of Dean Academics, AIIMS New Delhi , India Pin code : 110029 
Type of Sponsor  Government medical college 
 
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 Arvind Kumar   JPN apex trauma centre , AIIMS New Delhi  Department of orthopaedics ,JPN apex trauma centre, AIIMS New Delhi
South
DELHI 
9873181197

arvindmamc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Calcaneofibular ligament (CFL) preservation group  In the calcaneofibular ligament (CFL) preservation group, the calcaneal insertion of the CFL will be identified, osteotomized, and retracted along with the skin flap. The osteotomized fragment will be buried within the calcaneus beneath the calcaneal plate during positioning and secured to the plate with No. 2 FiberWire after definitive fixation.  
Comparator Agent  Calcaneofibular ligament (CFL) sectioning group   In the CFL section group, the ligament will be cut at the level of the subtalar joint and later repaired during closure using No. 1 vicryl suture.. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ISOLATED DISPLACED INTRA-ARTICULAR CALCANEAL FRACTURES SANDERS TYPE 2,3,4 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the Ankle/Foot function after ORIF of displaced Intra-articular calcaneal fractures in both the groups using MOXFQ at 3 months and 6 months and to compare it with the baseline ankle functions.
 
Baseline , 3 months , 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Radiological outcomes on Xray , CT scan  Immediate post op , 6 weeks , 3 month , 6 month 
Ankle/Hindfoot stability  3 month & 6 month 
Surgical parameters & complications  From surgery till 6 month 
 
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)   12/03/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Calcaneal fractures are complex, intra-articular injuries that significantly impair mobility and quality of life. Calcaneal fractures, especially displaced intraarticular variants (Sanders II-IV), pose challenging management issues due to their complexity and impact on hindfoot function. Standard operative management using the extensile lateral approach offers excellent visualization and reduction but often requires sectioning the calcaneofibular ligament (CFL) to access the posterior facet. Traditionally, ligament is cut at its insertion and repaired as a soft tissue structure; however, this is less robust than anatomical bone-to-bone healing and may limit restoration of native biomechanics.

Bone-to-bone healing, wherein the CFL is osteotomized with a bone fragment and reattached, is biologically superior to purely ligament-bone repair and is hypothesized to restore both biomechanical integrity and proprioception more completely. Literature shows CFL repair improves postoperative ankle stability but past studies have not employed bone-to-bone methods. This study aims to provide first-of-its-kind comparative data on functional  and detailed radiological outcomes between CFL repaired and unrepaired groups.

However not yet recruiting patients for this trial.
 
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