Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing

Anterior Cruciate Ligament Tear Clinical Trial

Official title:

Study of Surgical Methods for Anterior Cruciate Ligament Tearing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580722
• Other study ID #: ASD-1213-100
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2012
• Last updated: April 18, 2012
• Start date: March 2012
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 36 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Tear

Intervention

Procedure:
• early reconstruction
patients underwent < 8 weeks reconstruction after injury
• delay reconstruction
patients underwent > 8 weeks reconstruction after injury

Locations

Country	Name	City	State
Iran, Islamic Republic of	Al-zahra university hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life	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.	at 6 months post-operatively	Yes
Secondary	Tegner activity score	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.	at 6 months post-operatively	Yes
Secondary	Knee injury and Osteoarthritis Outcome Score	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 ) .	at 6 months post-operatively	Yes

External Links

•   Isfahan university of medical science