| CTRI Number |
CTRI/2026/01/101197 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Parameters evaluation in a cadaveric study |
|
Scientific Title of Study
|
Radiological morphological and histological evaluation of the os peroneum: A cadaveric 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 P S Mittal |
| Designation |
Professor |
| Affiliation |
Government Institute of Medical Sciences(GIMS) |
| Address |
Department of Anatomy GIMS, Greater Noida
Kasna
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9827395622 |
| Fax |
|
| Email |
pragatisheelmittal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharmendra Kumar |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences(GIMS) |
| Address |
Department of Anatomy GIMS, Greater Noida
Kasna
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8218777302 |
| Fax |
|
| Email |
dkgimsanat123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharmendra Kumar |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences(GIMS) |
| Address |
Department of Anatomy GIMS, Greater Noida
Kasna
UTTAR PRADESH
201310
India |
| Phone |
8218777302 |
| Fax |
|
| Email |
dkgimsanat123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Medical Sciences (GIMS) Kasna Greater Noida Gautam Buddha Nagar Uttar Pradesh Pin 201310 |
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Sciences (GIMS) |
| Address |
Kasna Greater Noida Gautam Buddha Nagar Uttar Pradesh Pin 201310 |
| 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 Dharmendra Kumar |
Government Institute of Medical Sciences(GIMS) |
Department of Anatomy Ground floor, Academic block Gims Hospital Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
8218777302
dkgimsanat123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GIMS Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
I. Cadavers received in GIMS Greater Noida ethnicity, aged 18 years and above.
II. Cadaveric specimens with well-preserved Right and Left foot structures.
III. Specimens with intact Os peroneum for histological examination.
IV. Cadaveric specimens of individuals originating from surrounding regions,
which are available at the Department of Anatomy, GIMS. |
|
| ExclusionCriteria |
| Details |
I. Cadaveric specimens with damaged or missing foot structures.
II. Specimens showing severe decomposition or poor preservation of the peroneus
Longus tendon and surrounding structures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a. Morphological characteristics of the Os Peroneum (size, shape, location,
number)
b. Radiological features (visibility, density, structure on X-ray) |
At the time of dissection at baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Histological composition (type of tissue, ossification, presence of cartilage
or bone)
b. Side-wise comparison outcomes (differences in features between right and
left) |
At the time of dissection at baseline only |
|
|
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)
|
25/02/2026 |
| 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="1"
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
|
1. Research Design: The study follows a descriptive, cross-sectional, observational, and cadaveric research design. 2. Research Setting: The present study will be conducted on 50 embalmed Lower Limbs; Consideration will be given to the sex of the specimens examined in comparing the Os Peroneum of two sides. In Radiological Study, The specimen of Os Peroneum will be exposed to X-rays to note the presence or absence of the Os Peroneum as it is visible when ossified only. In Cadaveric Study, Lateral part of foot and sole will be dissected to expose Peroneus Longus tendon and Os Peroneum. Various dimensions of Os Peroneum (max. length, max. breadth and max. thickness in accordance of its axis) and PL tendon (max. breadth and max. thickness, 1 cm proximal and distal to Os Peroneum) will be measured with the help of Scale and Digital Venire caliper. In Histological study, the specimen of Os Peroneum will be shifted for Histological study and will be stained with Haematoxylin and Eosin to be examined under Optical Microscope |