Anterior Cruciate Ligament RuptureNCT07470944
Arthroscopic ACL Reconstruction: Quadriceps Tendon vs Hamstring Tendon Autograft - A Prospective RCT
A study testing Arthroscopic ACL Reconstruction in people with Anterior Cruciate Ligament Rupture, run by Sawai Mansingh Medical College at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Arthroscopic ACL Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Grade 3 ACL tear confirmed on MRI • Age 15-55 years • Medically fit for surgery • Willing and able to complete 6-month follow-up
Who cannot join
- • Multi-ligament knee injury • Complex meniscal tears requiring additional procedures • Intra-articular fractures • Pre-existing osteoarthritis • Inability to attend follow-up
Trial locations and contacts
1 site in 1 country.
India1 site
Sawai Man Singh Medical College and Associated Hospitals
Jaipur, Rajasthan, 302004
About this study
Official title: 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.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Arthroscopic ACL Reconstruction
- Keywords
- ACL reconstruction; quadriceps tendon; hamstring tendon; autograft; knee; arthroscopy., ACL reconstruction; quadriceps tendon; hamstring tendon; autograft; knee; arthroscopy
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic ACL ReconstructionProcedure or surgery
Arthroscopic ACL reconstruction under tourniquet control using interference screw fixation
| Study group | Role | What they receive |
|---|---|---|
| Group A - Quadriceps Tendon Autograft | Active comparator | Arthroscopic ACL reconstruction using partial-thickness quadriceps tendon autograft without bone block Receives: Procedure: Arthroscopic ACL Reconstruction |
| Group B - Hamstring Tendon Autograft | Active comparator | Arthroscopic ACL reconstruction using semitendinosus and gracilis tendon autograft Receives: Procedure: Arthroscopic ACL Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
IKDC Subjective Knee Evaluation Score
Patient-reported functional outcome score (0-100, higher = better)
Measured: Pre-operative, 3 months, and 6 months post-surgery
Lysholm Knee Scoring Scale
Knee function scoring scale (0-100, higher = better)
Measured: Pre-operative, 3 months, and 6 months post-surgery
Secondary outcomes (3)
Lachman Test
Clinical test for anterior tibial translation at 30° knee flexion (positive/negative)
Measured: Pre-operative, 3 months, and 6 months post-surgery
Anterior Drawer Test
Clinical test for anterior tibial translation at 90° knee flexion (positive/negative)
Measured: Pre-operative, 3 months, and 6 months post-surgery
Pivot Shift Test
Clinical test for rotational knee instability (positive/negative)
Measured: Pre-operative, 3 months, and 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Jan 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sawai Mansingh Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sahil Jangra, Sawai Mansingh Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470944
- Sponsor's protocol ID
- SMSMC/ORTHO/ACL/2023
- Other IDs
- IEC SMS Medical College Jaipur
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Study on Functional Outcome of Arthroscopic Reconstruction of Anterior Cruciate Ligament Using Quadriceps Tendon Graft Versus Hamstrings Graft
- ClinicalTrials.gov ID
- NCT07470944
- Acronym / sponsor ID
- SMSMC/ORTHO/ACL/2023
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- ACL reconstruction; quadriceps tendon; hamstring tendon; autograft; knee; arthroscopy., ACL reconstruction; quadriceps tendon; hamstring tendon; autograft; knee; arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sawai Mansingh Medical CollegeOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Quadriceps Tendon Autograft | Active comparator | Procedure: Arthroscopic ACL ReconstructionArthroscopic ACL reconstruction using partial-thickness quadriceps tendon autograft without bone block |
| Group B - Hamstring Tendon Autograft | Active comparator | Procedure: Arthroscopic ACL ReconstructionArthroscopic ACL reconstruction using semitendinosus and gracilis tendon autograft |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Grade 3 ACL tear confirmed on MRI • Age 15-55 years • Medically fit for surgery • Willing and able to complete 6-month follow-up
Key exclusion criteria (1 listed)
- • Multi-ligament knee injury • Complex meniscal tears requiring additional procedures • Intra-articular fractures • Pre-existing osteoarthritis • Inability to attend follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic ACL ReconstructionArthroscopic ACL reconstruction under tourniquet control using interference screw fixation | Procedure or surgery | Group A - Quadriceps Tendon Autograft, Group B - Hamstring Tendon Autograft |
Primary outcome
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)
Lysholm Knee Scoring Scale
Time frame: Pre-operative, 3 months, and 6 months post-surgery
Knee function scoring scale (0-100, higher = better)
3 secondary outcomes
Lachman Test
Time frame: Pre-operative, 3 months, and 6 months post-surgery
Anterior Drawer Test
Time frame: Pre-operative, 3 months, and 6 months post-surgery
Pivot Shift Test
Time frame: Pre-operative, 3 months, and 6 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic ACL Reconstruction in people with Anterior Cruciate Ligament Rupture, run by Sawai Mansingh Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IKDC Subjective Knee Evaluation Score (time frame: Pre-operative, 3 months, and 6 months post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.