| CTRI Number |
CTRI/2024/05/067569 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between kneecap position and knee pain in collegiate players |
|
Scientific Title of Study
|
Association between patellar mal-alignment and anterior knee pain in collegiate players |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gayatri Kode |
| Designation |
Student |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9619855924 |
| Fax |
|
| Email |
gayatri1.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ganesh Balthillaya M |
| Designation |
Assistant Professor, Selection Grade |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448263631 |
| Fax |
|
| Email |
ganesh.bm@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Gayatri Kode |
| Designation |
Student |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9619855924 |
| Fax |
|
| Email |
gayatri1.mchpmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, MAHE, Udupi, Karnataka - 576104, India |
|
|
Primary Sponsor
|
| Name |
Gayatri Kode |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
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 John Solomon M |
Kasturba Hospital |
Room no. 101, Department of Physiotherapy, N1 OPD
Udupi
KARNATAKA |
9619855924
gayatri1.mchpmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patellar mal-alignment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
For case group – Complaints of anterior knee pain in addition to the inclusion criteria given below.
For control group – No complaints of anterior knee pain in addition to the inclusion criteria given below.
1. Age range: 18 - 28
2. Collegiate players – represent college in competition, in any sport (physically active games: Basketball, Volleyball, Athletics, Badminton, Swimming) for 1 year, practice more than 6 hours per week.
|
|
| ExclusionCriteria |
| Details |
1. Any recent lower limb fractures
2. Lower limb known ligament injuries.
3. Lower limb neurological conditions
4. Less than 3 months of soft tissue injuries
5. Diagnosed degenerative condition: Osteoarthritis, Chondromalacia patellae
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patellar mal-alignment |
one - at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL known |
NIL known |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
Final Enrollment numbers achieved (Total)= "94"
Final Enrollment numbers achieved (India)="94" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/05/2024 |
| Date of Study Completion (India) |
08/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The study will be conducted after receiving IRC and IEC approval and CTRI registration. Once IRC, IEC approvals and CTRI registration are completed, collegiate players aged 18 to 28, who represent the college in physically active sports and complain of anterior knee pain as well as those who do not complain of anterior knee pain will be recruited for the study to investigate the association between patellar mal-alignment and anterior knee pain. Study specifics will be explained to the participant and informed consent will be obtained. The patellar position will be evaluated using McConnell’s patellar orientation, jsign, and the ratio of patellar length to patellar tendon length in all the participants. Data analysis will be done using Jamovi software 2.3.28. |