| CTRI Number |
CTRI/2024/12/078774 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study among participants that includes patients with hip pain by using anthropometry, biomechanics and radiography as an intervention to assess its prevalence in the Indian population |
|
Scientific Title of Study
|
Prevalence of Femoro-Acetabular impingement amongst patients presenting with hip pain: An arthro-kinetic and
radiography-based 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 |
Garvit Gupta |
| Designation |
1st year MBBS student |
| Affiliation |
AIIMS Rajkot |
| Address |
AIIMS Rajkot, Gujarat
Rajkot
GUJARAT
360110
India |
| Phone |
8619445818 |
| Fax |
|
| Email |
garvitgupta823@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sundip Charmode |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Anatomy, Academic block, AIIMS Rajkot, KHANDHERI, RAJKOT-360110
Rajkot
GUJARAT
360110
India |
| Phone |
09633239685 |
| Fax |
|
| Email |
sundip.charmode@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sundip Charmode |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Anatomy, Academic block, AIIMS Rajkot, KHANDHERI, RAJKOT-360110
Rajkot
GUJARAT
360110
India |
| Phone |
09633239685 |
| Fax |
|
| Email |
sundip.charmode@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS) Rajkot, Gujarat-360110 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences (AIIMS) Rajkot |
| Address |
AIIMS Rajkot, KHANDHERI, RAJKOT, GUJARAT-360110 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sundip Charmode |
Department of Anatomy, Academic block, AIIMS Rajkot, KHANDHERI, RAJKOT, GUJARAT-360110 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sundip Charmode |
Anthropometry lab, AIIMS Rajkot |
Department of Anatomy, Academic block, AIIMS Rajkot, KHANDHERI, RAJKOT-360110
Rajkot
GUJARAT |
9633239685
sundip.charmode@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, AIIMS Rajkot |
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 |
16.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Those who will give written consent for the study
Those whose age is more than or equal to 16 years and less than 75 years.
Those who have symptoms of hip pain with or without clicking, catching or giving way
sensation.
Those who have X ray evidence of pincer and/ or cam-type FAI, defined as
a. Cam morphology that is alpha angle more than or equal to 60°
b. Pincer morphology that is lateral centre edge angle of more than 40° |
|
| ExclusionCriteria |
| Details |
Those who did not give written consent for the study,
Those whose age is less than 16 years,
Those who have previous history of significant hip pathology such as Perthes’ disease, slipped upper femoral epiphysis or avascular necrosis.
Those having previous history of hip injury such as acetabular fracture, hip dislocation or femoral neck fracture.
Those who have previous h/o any procedure either open or arthroscopic in the hip. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To determine the prevalence of Femoro-acetabular impingement (FAI) in patients
presenting with hip pain through radiographic analysis.
2. To elucidate the correlation between radiographic manifestations of FAI and the
biomechanics of the hip joint.
3. To identify variations in hip morphology contributing to the development of
Femoro-acetabular impingement syndrome.
4. To enhance awareness among FAI patients about the significance of physical
therapy, lifestyle adjustments, and modifications in gait and posture. |
In the month of May and June 2024: Conceptualize, develop & submission (online) of research concept note.
In between 2nd & 3rd professional year i.e. in the month of May and June 2025: Collection of data.
In between 3rd & 4th professional year i.e. in the month of May and June 2026: Analysis of data, preparation & submission (online) of report.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. This study shall facilitate the student to learn radiographic analytical skills of
femoro-acetabular impingement.
2. This study shall enable the student to learn how to conduct anthropometric and
biomechanical assessment of hip joint.
3. The study observations will help to determine the prevalence of femoro-acetabular
impingement in different age groups, occupation wise groups, and its sexual
dimorphism.
4. This study seek to correlate symptoms of femoro-acetabular impingement (FAI)
with radiographic findings and biomechanical measurements, aiming to delineate
whether management strategies should be dictated by functional demands or
clinical assessments. |
In the month of May and June 2024: Conceptualize, develop & submission (online) of research concept note.
In between 2nd & 3rd professional year i.e. in the month of May and June 2025: Collection of data.
In between 3rd & 4th professional year i.e. in the month of May and June 2026: Analysis of data, preparation & submission (online) of report.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/01/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response (Others) - The observations of this study which will be the qualitative and quantitative data arising from the study patients will be shared in an unidentified form in the publication arising out of this study. This shall be done only after taking the informed consent from the participants/patients. The host institute AIIMS Rajkot shall be intimated about it and all the study participants will also be informed about their research findings at the end of the study.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response (Others) - Those authors who wish to conduct a systematic review and meta-analysis shall get the access of the above-mentioned data provided they follow all the journal rules, regulations and ethical considerations. In this regard, permission will also have to be taken from ICMR, AIIMS Rajkot and the principal investigator and his guide.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sundip.charmode@yahoo.com].
- For how long will this data be available start date provided 26-12-2027 and end date provided 26-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This cross-sectional observational study focuses on the prevalence of Femoro-acetabular impingement (FAI) among patients presenting with hip pain in an orthopedic outpatient setting in AIIMS Rajkot. FAI is caused by abnormal bone shapes at the femoral head-neck junction (cam-type) or acetabulum (pincer-type), leading to joint damage during extreme or repetitive hip motions. despite its clinical significance, FAI is often overlooked in India, where primary hip osteoarthritis is rare. The study aims to determine the prevalence of FAI using radiographic analysis, correlate radiographic manifestations with hip biomechanics, and identify morphological variations contributing to FAI syndrome. Additionally, it seeks to raise awareness about the role of physical therapy, lifestyle changes and gait/posture modifications in preventing FAI progression to osteoarthritis. This cross-sectional observational study will involve 60 participants aged 16 years and above, randomly selected from patients with hip pain. Data collection will include demographic details, lifestyle factors, clinical symptoms, and radiographic findings, with the latter evaluated through alpha angles and lateral center-edge angles for cam and pincer morphologies. This data collection shall be done using a specially designed questionnaire/patient record form. Biomechanical assessments will measure hip joint range of motion and correlate these with radiographic findings. The radiographic findings (X ray scans) will be assessed by inserting the X ray scan copies into RADIANT DICOM VIEWER software. This entire data collection and its analysis shall be done by the principal investigator who is a MBBS student. He shall be thoroughly guided by a GUIDE who is a medical faculty, in the Department of Anatomy in the same institute. Data will be analyzed using SPSS, with statistical significance set at p<0.05. The findings will provide insights into FAI prevalence across different age groups, genders, and occupational categories, while contributing to improved diagnostic and management strategies. Furthermore, the study aims to educate healthcare providers and patients on preventive measures to mitigate long term complications like hip osteoarthritis. |