NCT07470944

Brief 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. Outcomes assessed using IKDC score, Lysholm score, and clinical stability tests at pre-operative, 3-month, and 6-month intervals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

March 10, 2026

Last Update Submit

March 10, 2026

Conditions

Keywords

ACL reconstruction; quadriceps tendon; hamstring tendon; autograft; knee; arthroscopy.ACL reconstruction; quadriceps tendon; hamstring tendon; autograft; knee; arthroscopy

Outcome Measures

Primary Outcomes (2)

  • IKDC Subjective Knee Evaluation Score

    Patient-reported functional outcome score (0-100, higher = better)

    Pre-operative, 3 months, and 6 months post-surgery

  • Lysholm Knee Scoring Scale

    Knee function scoring scale (0-100, higher = better)

    Pre-operative, 3 months, and 6 months post-surgery

Secondary Outcomes (3)

  • Lachman Test

    Pre-operative, 3 months, and 6 months post-surgery

  • Anterior Drawer Test

    Pre-operative, 3 months, and 6 months post-surgery

  • Pivot Shift Test

    Pre-operative, 3 months, and 6 months post-surgery

Study Arms (2)

Group A - Quadriceps Tendon Autograft

ACTIVE COMPARATOR

Arthroscopic ACL reconstruction using partial-thickness quadriceps tendon autograft without bone block

Procedure: Arthroscopic ACL Reconstruction

Group B - Hamstring Tendon Autograft

ACTIVE COMPARATOR

Arthroscopic ACL reconstruction using semitendinosus and gracilis tendon autograft

Procedure: Arthroscopic ACL Reconstruction

Interventions

Arthroscopic ACL reconstruction under tourniquet control using interference screw fixation

Group A - Quadriceps Tendon AutograftGroup B - Hamstring Tendon Autograft

Eligibility Criteria

Age15 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Grade 3 ACL tear confirmed on MRI • Age 15-55 years • Medically fit for surgery • Willing and able to complete 6-month follow-up

You may not qualify if:

  • Multi-ligament knee injury • Complex meniscal tears requiring additional procedures • Intra-articular fractures • Pre-existing osteoarthritis • Inability to attend follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sawai Man Singh Medical College and Associated Hospitals

Jaipur, Rajasthan, 302004, India

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Resident, Department of Orthopaedics

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start

January 1, 2023

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations