NCT01537588

Brief Summary

The aim of this study is to gain new knowledge on the impact of hamstring tendon harvest and apply that knowledge to the treatment and management of patients who undergo anterior cruciate ligament (ACL) reconstruction. There are three main components of this study:

  1. 1.How do muscle shape, size, strength, and ability to function change following hamstring grafting for ACL reconstruction;
  2. 2.How does physical activity change following ACL reconstruction;
  3. 3.Is there a difference in outcome if graft harvest is done from the injured versus uninjured limbs

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable

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

July 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

3 years

First QC Date

February 14, 2012

Last Update Submit

March 9, 2015

Conditions

Isolated Anterior Cruciate Ligament Rupture

Keywords

anterior cruciate ligamenthamstringsemitendinosusgracilisgraft

Outcome Measures

Primary Outcomes (1)

  • Muscle cross sectional area

    Measured on bilateral MRI taken from ischial tuberosity to 10 cm below knee joint line

    12 months post-surgery

Secondary Outcomes (2)

  • Knee flexion and extension isokinetic strength

    12-months post-surgery

  • Physical activity

    12 months post-surgery

Study Arms (3)

Standard

ACTIVE COMPARATOR

ACL reconstruction with autograft harvest of STG from ACL-deficient leg

Other: Autograft STG harvest from ACL-deficient leg

Autograft harvest of STG from ACL-deficient leg

EXPERIMENTAL

Autograft harvest of STG from leg contralateral to ACL-deficient leg

Other: Autograft harvest contralateral to ACL-deficient leg

Normal matched

NO INTERVENTION

Interventions

Autograft STG harvest from ACL-deficient legOTHER

Semitendinosus-gracilis graft harvest is undertaken on same limb that is undergoing ACL reconstruction

Standard
Autograft harvest contralateral to ACL-deficient legOTHER

Semitendinosus-gracilis graft harvest is undertaken on limb contralateral to that undergoing ACL reconstruction

Autograft harvest of STG from ACL-deficient leg

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • between 18 and 50 years old; isolated ACL rupture confirmed on MRI

You may not qualify if:

  • other physical or mental health issues that affect ability to complete rehabilitation and/or study follow-ups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Location

Study Officials

  • Sheila McRae, MSc

    University of Manitoba, Pan Am Clinic Foundation

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 14, 2012

First Posted

February 23, 2012

Study Start

July 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

CA(1)