- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07470944
Arthroscopic ACL Reconstruction: Quadriceps Tendon vs Hamstring Tendon Autograft - A Prospective RCT
March 10, 2026 updated by: Sahil Jangra, Sawai Mansingh Medical College
Prospective Comparative Study on Functional Outcome of Arthroscopic Reconstruction of Anterior Cruciate Ligament Using Quadriceps Tendon Graft Versus Hamstrings Graft
A prospective randomized controlled trial comparing functional outcomes of arthroscopic anterior cruciate ligament reconstruction using quadriceps tendon autograft versus hamstring tendon autograft at SMS Medical College, Jaipur.
Outcomes assessed using IKDC score, Lysholm score, and clinical stability tests at pre-operative, 3-month, and 6-month intervals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rajasthan
-
Jaipur, Rajasthan, India, 302004
- Sawai Man Singh Medical College and Associated Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Grade 3 ACL tear confirmed on MRI • Age 15-55 years • Medically fit for surgery • Willing and able to complete 6-month follow-up
Exclusion Criteria:
- • Multi-ligament knee injury • Complex meniscal tears requiring additional procedures • Intra-articular fractures • Pre-existing osteoarthritis • Inability to attend follow-up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A - Quadriceps Tendon Autograft
Arthroscopic ACL reconstruction using partial-thickness quadriceps tendon autograft without bone block
|
Arthroscopic ACL reconstruction under tourniquet control using interference screw fixation
|
|
Active Comparator: Group B - Hamstring Tendon Autograft
Arthroscopic ACL reconstruction using semitendinosus and gracilis tendon autograft
|
Arthroscopic ACL reconstruction under tourniquet control using interference screw fixation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IKDC Subjective Knee Evaluation Score
Time Frame: Pre-operative, 3 months, and 6 months post-surgery
|
Patient-reported functional outcome score (0-100, higher = better)
|
Pre-operative, 3 months, and 6 months post-surgery
|
|
Lysholm Knee Scoring Scale
Time Frame: Pre-operative, 3 months, and 6 months post-surgery
|
Knee function scoring scale (0-100, higher = better)
|
Pre-operative, 3 months, and 6 months post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lachman Test
Time Frame: Pre-operative, 3 months, and 6 months post-surgery
|
Clinical test for anterior tibial translation at 30° knee flexion (positive/negative)
|
Pre-operative, 3 months, and 6 months post-surgery
|
|
Anterior Drawer Test
Time Frame: Pre-operative, 3 months, and 6 months post-surgery
|
Clinical test for anterior tibial translation at 90° knee flexion (positive/negative)
|
Pre-operative, 3 months, and 6 months post-surgery
|
|
Pivot Shift Test
Time Frame: Pre-operative, 3 months, and 6 months post-surgery
|
Clinical test for rotational knee instability (positive/negative)
|
Pre-operative, 3 months, and 6 months post-surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
May 31, 2024
Study Completion (Actual)
May 31, 2024
Study Registration Dates
First Submitted
March 10, 2026
First Submitted That Met QC Criteria
March 10, 2026
First Posted (Actual)
March 13, 2026
Study Record Updates
Last Update Posted (Actual)
March 13, 2026
Last Update Submitted That Met QC Criteria
March 10, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMSMC/ORTHO/ACL/2023
- IEC SMS Medical College Jaipur (Other Identifier: SMS Medical College Jaipur)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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