| CTRI Number |
CTRI/2025/09/095071 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of accuracy between Long vs Short leg X rays with Non-contrast computerized tomography (NCCT) for evaluation of posterior tibial slope in adult patients |
|
Scientific Title of Study
|
Comparison of accuracy between Long vs Short leg X rays with Non-contrast computerized tomography (NCCT) for evaluation of posterior tibial slope in adult patients-A Prospective 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 |
Arunachalam |
| Designation |
Orthopedic Junior resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Orthopedic department
Jawaharlal institute of postgraduate medical education and research
Dhanvantari Nagar
Gorimedu,Puducherry. Orthopedic department
Jawaharlal institute of postgraduate medical education and research
Dhanvantari Nagar
Gorimedu,Puducherry. Pondicherry PONDICHERRY 605006 India |
| Phone |
7639003711 |
| Fax |
0413-2272067 |
| Email |
arunaamresh1922@gamil.com |
|
Details of Contact Person Scientific Query
|
| Name |
Gopishankar |
| Designation |
Professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Orthopedic department
Jawaharlal institute of postgraduate medical education and research
Dhanvantari Nagar
Gorimedu,Puducherry. Orthopedic department
Jawaharlal institute of postgraduate medical education and research
Dhanvantari Nagar
Gorimedu,Puducherry. Pondicherry PONDICHERRY 605006 India |
| Phone |
9360330582 |
| Fax |
0413-2272067 |
| Email |
drgopi9596@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Gopishankar |
| Designation |
Professor |
| Affiliation |
JIPMER |
| Address |
Orthopedic department
Jawaharlal institute of postgraduate medical education and research
Dhanvantari Nagar
Gorimedu,Puducherry. Orthopedic department
Jawaharlal institute of postgraduate medical education and research
Dhanvantari Nagar
Gorimedu,Puducherry. Pondicherry PONDICHERRY 605006 India |
| Phone |
9360330582 |
| Fax |
0413-2272067 |
| Email |
drgopi9596@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal institute of postgraduate medical education and research |
| Jawaharlal institute of postgraduate medical education and research |
|
|
Primary Sponsor
|
| Name |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Orthopedic department
Jawaharlal institute of postgraduate medical education and research
Dhanvantari Nagar
Gorimedu,Puducherry. |
| 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 Arunachalam |
JIPMER |
Orthopedic department
Jawaharlal institute of postgraduate medical education and research
Dhanvantari Nagar
Gorimedu,Puducherry. Pondicherry PONDICHERRY |
7639003711 - arunaamresh1922@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Who is coming to OPD with complaints of knee pain |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age of 18 years and above
2.Patients presenting with knee pain more than 1 month.
|
|
| ExclusionCriteria |
| Details |
1.patients with past h/o any orthopaedic intervention on the same limb
2.patients with medical disease like hemophilia, rheumatoid arthritis etc..
3.patients with suspected tumor. on the same limb
4.patient with previous fracture or deformity(coronal , sagittal plane ) in same limb
5.patients with radiological osteoarthritis kellgren and Lawrence grade 3 and 4 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out gold standard investigation for evaluation of posterior tibial slope |
6months to 1 year morning x-ray followed by evening CT to measure the tibial slope angle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To get benefits for future people |
6 months to 2 years |
|
|
Target Sample Size
|
Total Sample Size="104" Sample Size from India="104"
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)
|
01/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/10/2025 |
| 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
|
Tibial slope is defined as the angle between the perpendicular to the middle part of the diaphysis of the tibia and the line representing the posterior inclination of the tibial plateau. A common knee radiograph: the connection of two points equidistant between the anterior and posterior border of the tibia, one just below the tibial tubercle [on average 5 cm (2.36 in.) below the most proximal point of the tibia and the other 15 cm (6.3 in.) below the most proximal point]. It is not clear how the results of this measurement technique relate to the PTS defined by the mechanical axis of the lower limb During weight bearing, as the slope of the tibial plateau increases, the magnitude of the anteriorly directed shear force component that is as associated with the compressive joint force on the tibia also increases. The geometry of the tibial plateau also has been studied as an important factor in total knee arthroplasty, anterior cruciate ligament injury and cases in which osteotomy is performed to restore normal alignment of the knee. The main identifying measurement is the posterior slope as measured on lateral radiographs, on which the medial and lateral tibial plateaus are superimposed. However, the measured slope is a two-dimensional approximation of a complex, asymmetric, and three-dimensional surface; it ignores the differences in the medial and lateral aspects of the tibia.
|