NCT00221273

Brief Summary

Compares tension of an ACL graft when using a commercial device vs. the tension of the graft applied by a physician during surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

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

First Submitted

Initial submission to the registry

September 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
5.2 years until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2012

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

September 18, 2005

Last Update Submit

March 1, 2017

Conditions

Torn Anterior Cruciate Ligament (Knee)

Outcome Measures

Primary Outcomes (1)

  • Endpoints Measured at 6, 12, 18 months post op compared to pre-op

Interventions

ACL surgeryPROCEDURE

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Torn ACL amenable to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • J Leith, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2005

First Posted

September 22, 2005

Study Start

December 1, 2010

Primary Completion

May 18, 2012

Study Completion

May 18, 2012

Last Updated

March 3, 2017

Record last verified: 2017-03