Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing

Study of Surgical Methods for Anterior Cruciate Ligament Tearing

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01580722

Enrollment

202

Registered

2012-04-19

Start date

2012-03-31

Completion date

2012-04-30

Last updated

2012-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Tear

Keywords

Anterior Cruciate Ligament,Early,Delay,Reconstruction

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.

Interventions

PROCEDUREearly reconstruction

patients underwent \< 8 weeks reconstruction after injury

PROCEDUREdelay reconstruction

patients underwent \> 8 weeks reconstruction after injury

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 36 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 ) .

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026