Comparison of outcome of all inside anterior cruciate ligament reconstruction using semitendinosus autograft with and without augmentation, A prospective randomized control trial.â€

Phase 2/3

Not yet recruiting

• Conditions: Chronic instability of knee,

• Registration Number: CTRI/2020/03/023928
• Lead Sponsor: AIIMS NEW DELHI

Brief Summary

**Methodology**-

We will first clinically assess the patient withchronic ACL tear for signs (subjective tests) and symptoms of ACL injury. Allthe demographic information of the patient like age, sex, occupation, side ofaffected limb, mode of injury, injury operation interval involvement in sportsactivities will be collected. Patient will have to get preanesthetic clearance.Patient will be evaluated for Visual analogue score for pain, Lysholmfunctional knee score, Tegner activity scale, KT1000 Laxity measurement andsubjective tests for knee laxity and results will be recorded.  On the background of diagnosis and symptoms,patient fulfilling the above mentioned criteria will be allocated in two groupafter proper randomization and treated accordingly.  Post operatively patient will be followed upat 2, 4 and 6 months. In follow-up of the patient will be again evaluated forVisual analogue score for pain, Lysholm functional knee score, Tegner activityscale   KT1000 Laxity measurement and subjective testsfor knee laxity and results will be recorded.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-18
• Last Update Posted: 2020-08-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• INCLUSION CRITERIA: a)Isolated complete ACL tear b)ACL deficient Patients having symptom of instability or giving way of the involved knee.
• c)Patient age 16-40 year d)No radiological arthritic changes in affected knee.
• e)Patient willing to participate in study.

Exclusion Criteria

• EXCLUSION CRITERIA- a)ACL injury associated with other collateral ligament and posterior cruciate ligament injury.
• b)Asymptomatic ACL deficient patients c)Age less than 16 year or more than 40 year.
• d)Radiological arthritic changes in affected knee.
• e)Patient refused to participate in study f)Any prior surgery in ipsilateral knee.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Tegner activity scale	SIX MONTHS AFTER THE SURGERY
•KT 1000 arthrometer laxity measurements	SIX MONTHS AFTER THE SURGERY
•Lysholm functional knee score	SIX MONTHS AFTER THE SURGERY
•Subjective examination {Lachmen test, Anterior drawer test, Pivot shift test}	SIX MONTHS AFTER THE SURGERY
•Pain ( visual analogue scale)	SIX MONTHS AFTER THE SURGERY

Secondary Outcome Measures

Name	Time	Method
PROTECTIVE EFFECT OF AUGMENTATION	Post operatively patient will be followed up at 2, 4 and 6 months

Trial Locations

Locations (1)

All India Institute of MedicalScience NEW DELHI; 🇮🇳 East, DELHI, India

All India Institute of MedicalScience NEW DELHI

🇮🇳East, DELHI, India

DR SIDDHARTH JAIN

Principal investigator

8989097791

dr.sidrjain@gmail.com