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Completed

NCT Number: NCT01580722

Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing

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

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Key information

Conditions

Anterior Cruciate Ligament Tear Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–36 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Al-zahra university hospital

Isfahan, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • 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
  • Bi-compartmental extensive meniscus resections
  • A cartilage injury representing a full thickness loss down to bone
  • A total rupture of MCL/LCL as visualized on MRI

Treatment and study plan

early reconstruction

Procedure

patients underwent < 8 weeks reconstruction after injury

delay reconstruction

Procedure

patients underwent > 8 weeks reconstruction after injury

Primary outcomes

  1. quality of life

    Time frame: 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 outcomes

  1. Tegner activity score

    Time frame: 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.

  2. Knee injury and Osteoarthritis Outcome Score

    Time frame: 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 ) .

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Study of Surgical Methods for Anterior Cruciate Ligament Tearing

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 19, 2012
Registry last updated
Apr 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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