| CTRI Number |
CTRI/2024/05/067655 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Hamstring lengthening vs. Hamstring lengthening and transfer for treating Knee Flexion Deformity in Cerebral Palsy - A comparative study |
|
Scientific Title of Study
|
Comparison of Medial Hamstring Lengthening with Combined Hamstring Lengthening and Semi-tendinosus Transfer for treatment of Knee Flexion Deformity in Cerebral Palsy |
| 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 Utkarsh Singhal |
| Designation |
Postgraduate Resident |
| Affiliation |
Lady Hardinge Medical College and Associated Hospitals, New Delhi |
| Address |
Department of Orthopaedics, Lady Hardinge Medical College and Associated Hospitals
Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
8882738338 |
| Fax |
|
| Email |
dr.utkarshsinghal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Alok Sud |
| Designation |
Director Professor and Head, Department of Orthopaedics |
| Affiliation |
Lady Hardinge Medical College and Associated Hospitals, New Delhi |
| Address |
Department of Orthopaedics, Lady Hardinge Medical College and Associated Hospitals
Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
avimukta2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Utkarsh Singhal |
| Designation |
Postgraduate Resident |
| Affiliation |
Lady Hardinge Medical College and Associated Hospitals, New Delhi |
| Address |
Department of Orthopaedics, Lady Hardinge Medical College and Associated Hospitals
Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
8882738338 |
| Fax |
|
| Email |
dr.utkarshsinghal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College and Associated Hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi - 110001 |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College and Associated Hospitals |
| Address |
Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi - 110001 |
| 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 Utkarsh Singhal |
Lady Hardinge Medical College and Associated Hospitals |
Out Patient Department, Emergency Department, and Cerebral Palsy Clinic, Department of Orthopaedics, Lady Hardinge Medical College and Associated Hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi - 110001
New Delhi
DELHI |
8882738338
dr.utkarshsinghal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Lady Hardinge Medical College and Associated Hospitals, Shaheed Bhagat Singh Marg, New Delhi - 110001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, (3) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combined Medial Hamstring Lengthening and Semi-tendinosus Transfer surgery |
Intra-muscular tenotomy of the Gracilis, Fractional lengthening of the Semi-membranosus, and transfer of the Semi-tendinosus onto the Adductor tubercle of Distal Femur. 15 patients will undergo the Intervention procedure, and the outcomes will be compared with those of the comparator over a follow up period of 6 months. |
| Comparator Agent |
Medial Hamstring Lengthening surgery |
Intra-muscular tenotomy of the Gracilis, Fractional lengthening of the Semi-membranosus, and Z-lengthening of the Semi-tendinosus muscle. 15 patients will undergo the Comparator procedure, and the outcomes will be compared with those of the intervention over a follow up period of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 7-12 years old, diagnosed with spastic hemiplegic/diplegic Cerebral Palsy with Knee flexion deformity (of all degrees of severity) of unilateral/bilateral knees showing flexed knee gait |
|
| ExclusionCriteria |
| Details |
Patients with GMFCS Score greater than 3, Patients with history of past surgical intervention for knee deformity correction, Patients with cognitive disorders or syndromes |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with completely corrected knee flexion deformity |
3 weeks, 3 months, 6 months post-op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in flexion deformity |
3 weeks, 3 months, 6 months post-op |
| Change in popliteal angle |
3 weeks, 3 months, 6 months post-op |
Change in bilateral popliteal angle
|
3 weeks, 3 months, 6 months post-op |
| Post-op Anterior Pelvic Tilt |
3 weeks, 3 months, 6 months post-op |
| Change in GMFCS Score |
3 weeks, 3 months, 6 months post-op |
| Improvement in gait |
3 weeks, 3 months, 6 months post-op |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/06/2024 |
| Date of Study Completion (India) |
10/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/07/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
Modification(s)
|
The trial is a comparison of 2 standard surgical procedures for knee flexion deformity correction - Medial Hamstring lengthening, compared with Combined Medial Hamstring lengthening with Semi-tendinosus transfer. The aim of the study is to compare the post-operative outcomes of both the surgeries to aid orthopedic surgeons in choosing one procedure over the other. The primary and secondary outcome variables will be assesed at a period of 3 weeks, 3 months, and 6 months post-op and analysed. |