Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing

Phase 2

Completed

• Conditions: Anterior Cruciate Ligament Tear
• Interventions: Procedure: early reconstruction; Procedure: delay reconstruction

• Registration Number: NCT01580722
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

The purpose of this study is to determine which surgical method is better for anterior cruciate ligament teas in outcomes.

Detailed Description

The anterior cruciate ligament (ACL) is one of the most commonly injured ligaments of the knee. This study was conducted to determine whether the outcome of treatment is superior in early surgical reconstruction compared with optional delay reconstruction.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-03
• Status Verified: 2012-04
• Study Completion: 2012-04
• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2012-04-18
• Last Update Submitted: 2012-04-18
• Study First Posted: 2012-04-19
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

a. patients with confirmed anterior cruciate ligament tearing

Exclusion Criteria

One of the following associated injuries to the index knee as visualized on MRI and/or arthroscopy:

1. An unstable longitudinal meniscus tear that requires repair and where the following postoperative treatment (i.e. bracing and limited ROM) interferes with the rehabilitation protocol
2. Bi-compartmental extensive meniscus resections
3. A cartilage injury representing a full thickness loss down to bone
4. A total rupture of MCL/LCL as visualized on MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early	early reconstruction	patients underwent \< 8 weeks reconstruction after injury
delay	delay reconstruction	patients underwent \> 8 weeks reconstruction after injury

Primary Outcome Measures

Name	Time	Method
quality of life	at 6 months post-operatively	SF-36 questionnaire consists of 36 questions (two main components: physical and mental), each of which was assigned a score ranging from 0 to 100.

Secondary Outcome Measures

Name	Time	Method
Tegner activity score	at 6 months post-operatively	The Tegner Activity Scale depicts the level of sporting activity and allows us to compare and document the preinjury activity level with the present activity level. This numeric score ranging from 1 to 10 where 1 is the least strenuous activity for the knee and 10 is the hardest.
Knee injury and Osteoarthritis Outcome Score	at 6 months post-operatively	The Knee injury and Osteoarthritis Outcome Score is the extended form of The Western Ontario and McMaster Universities Arthritis Index (WOMAC) with 42 - items in 5 subscales consisting : pain ( 9 items ) , other symptoms ( 7 items ) , activities of daily living ( 17 items ) , sports and recreational function ( sport / rec ) ( 5 items ) , and knee - related quality of life ( QOL ) ( 4 items ) .

Trial Locations

Locations (1)

Al-zahra university hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of