| CTRI Number |
CTRI/2025/11/098207 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING GRAFT AND ITS ADVANTAGES |
|
Scientific Title of Study
|
A prospective study to analyse functional outcome, Donor site morbitity and complications in hamstring tendon autograft for anterior cruciate ligament reconstruction in a tertiary care centre |
| 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 SHARATHGOWDA KN |
| Designation |
POST GRADUATE |
| Affiliation |
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
| Address |
Rooms no 16
Department of Orthopaedics SIMS AND RC
SAPTHAGIRI CAMPUS
CHIKKABANAVARA
Bangalore Rural
KARNATAKA
560090
India |
| Phone |
8867615832 |
| Fax |
|
| Email |
sharathgowda95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DEEPAK B V |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
| Address |
Room no 16
Department of Orthopaedics SIMS AND RC
SAPTHAGIRI CAMPUS
CHIKKABANAVARA
Bangalore Rural
KARNATAKA
560090
India |
| Phone |
9620426964 |
| Fax |
|
| Email |
bv.deepak975@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHARATHGOWDA KN |
| Designation |
POST GRADUATE |
| Affiliation |
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
| Address |
Room no 16
Department of Orthopaedics SIMS AND RC
SAPTHAGIRI CAMPUS
CHIKKABANAVARA
Bangalore Rural
KARNATAKA
560090
India |
| Phone |
8867615832 |
| Fax |
|
| Email |
sharathgowda95@gmail.com |
|
|
Source of Monetary or Material Support
|
| SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
SAPTHAGIRI CAMPUS
CHIKKABANAVARA
BENGALURU 560090
KARNATAKA
INDIA |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF ORTHOPAEDICS |
| Address |
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
HESARAGHATTA ROAD, CHIKKABANAVARA
BENGALURU 560090 |
| 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 |
| Sharath Gowda K N |
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
DEPARTMENT OF ORTHOPAEDICS, SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE, NAVY LAYOUT, CHIKKASANDRA, CHIKKABANAVARA, HESARAGHATTA ROAD, BENGALURU - 560090
Bangalore
KARNATAKA |
9483676762
sharathgowda95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SIMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
arthroscopic surgery |
Arthroscopic Anterior Cruciate Ligament Reconstruction with Hamstring graft |
| Comparator Agent |
Not Applicable |
Not Applicable as here only ACL reconstruction with hamstring graft and its advantages are assessed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Symptomatic anterior cruciate ligament insufficiency associated with or without meniscal or chondral injury.
MRI evidence of anterior cruciate ligament tear.
Examination under anaesthesia showing evidence of anterior cruciate ligament insufficiency like Lachman test and pivot shift test positive |
|
| ExclusionCriteria |
| Details |
Dislocated knee joint.
Grade 3 collateral ligament insufficiency.
Multi ligamentous injury.
Neurovascular insufficiency of affected limb. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the functional outcome and donor site morbidity of arthroscopic anterior cruciate ligament reconstruction with hamstring tendon autograft.
To analyse complications in above mentioned procedure. |
At 4 weeks, At 8 weeks and At 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyse complications in above mentioned procedure. |
At 4 weeks, At 8 weeks & At 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/12/2025 |
| 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) |
Open to Recruitment |
|
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 most common significant ligamentous injury to the knee joint is an anterior cruciate ligament tear. Recurrent injuries have a higher risk of intra-articular damage, particularly to the meniscus. The ACL reconstruction aims to restore knee stability, allow the patient to return to regular activities, including sports, and delay the onset of osteoarthritis. The choice of graft plays a vital role and the most popular autograft for reconstruction is the hamstring tendon graft. The aim of this study is to assess the functional outcome and donor site morbidity and analyse complications. A total of 30 patients who fulfill the criteria will be included and observed prospectively for a period of 6 months. Functional scores will be recorded preoperatively and 6 months after surgery. Donor site morbidities will be assessed with MRC grading for hamstring- flexion at knee and extension at hip. |