NCT01025895

Brief Summary

ACL tear is a common injury among athletes. The recommended treatment includes reconstruction of the ligament. The common reconstruction technique is single bundle reconstruction. However, this technique does not simulate the natural structure of the ligament. The purpose of the study is to compare between the common procedure, Single Bundle reconstruction with the Double Bundle reconstruction technique.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2010

Typical duration for phase_4

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed
28 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

December 4, 2009

Status Verified

July 1, 2009

Enrollment Period

1 year

First QC Date

December 3, 2009

Last Update Submit

December 3, 2009

Conditions

Anterior Cruciate Ligament Tear

Keywords

arthroscopic surgical procedure

Outcome Measures

Primary Outcomes (1)

  • WOMAC, VAS, SF-36, Lisholm, Knee society score, isokinetic muscle strength testing, Single HOP test , Tripple Hop Test

    pre-op. 1 day post op., 7-14 days post op., 6 weeks post op., 12 weeks post op., 26 weeks post op., 1 year post op., 2 years post op.

Study Arms (2)

single bundle

ACTIVE COMPARATOR

acl reconstruction - single bundle technique

Procedure: acle reconstruction - single bundle technique

double bundle

EXPERIMENTAL

acl reconstruction - double bundle technique

Procedure: acl reconstruction - double bundle technique

Interventions

acl reconstruction - double bundle techniquePROCEDURE
double bundle
acle reconstruction - single bundle techniquePROCEDURE
single bundle

Eligibility Criteria

Age16 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • knee instability with a history of ACL tear
  • diagnosed ACL tear according to MRI
  • age range 16-40.

You may not qualify if:

  • previous surgery in the knees
  • multiple ligament raptures
  • partial ACL tear
  • severe cartilage degeneration
  • genovaruse/genovalgus
  • thin hamstrings tendons
  • oper epiphysis in the knee joint
  • patient with muscle/neurological problem that increases the tendency to fall

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 4, 2009

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2013

Last Updated

December 4, 2009

Record last verified: 2009-07