NCT01580722

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

Same day

First QC Date

April 18, 2012

Last Update Submit

April 18, 2012

Conditions

Anterior Cruciate Ligament Tear

Keywords

Anterior Cruciate Ligament,Early,Delay,Reconstruction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Tegner activity score

    at 6 months post-operatively

  • Knee injury and Osteoarthritis Outcome Score

    at 6 months post-operatively

Study Arms (2)

early

OTHER

patients underwent \< 8 weeks reconstruction after injury

Procedure: early reconstruction

delay

OTHER

patients underwent \> 8 weeks reconstruction after injury

Procedure: delay reconstruction

Interventions

early reconstructionPROCEDURE

patients underwent \< 8 weeks reconstruction after injury

early
delay reconstructionPROCEDURE

patients underwent \> 8 weeks reconstruction after injury

delay

Eligibility Criteria

Age18 Years - 36 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • a. patients with confirmed anterior cruciate ligament tearing

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-zahra university hospital

Isfahan, Isfahan, Iran

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • hamidreza shemshaki, MD

    MD,research comittee

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle

Study Record Dates

First Submitted

April 18, 2012

First Posted

April 19, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2012

Study Completion

April 1, 2012

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations

IR(1)