| 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
|
|
|
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
|
|
|
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 |
|
|
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. |