NCT00564837

Brief Summary

This study was designed to determine whether or not there were any differences in knee range of motion, both statically and during gait, sagittal plane knee laxity, and quadriceps and hamstrings strength in patients three months post-ACL reconstruction with a bone-patellar tendon-bone autograft based on their performance of a primarily home based rehabilitation program or a standard physiotherapy-supervised program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 1999

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

September 1, 1999

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2001

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 28, 2007

Completed
Last Updated

January 12, 2010

Status Verified

January 1, 2010

Enrollment Period

1.4 years

First QC Date

November 26, 2007

Last Update Submit

January 11, 2010

Conditions

ACL Reconstruction

Keywords

Anterior cruciate ligamentReconstructionRehabilitationHome-based

Outcome Measures

Primary Outcomes (1)

  • Active assisted knee flexion and passive knee extension range of motion

    pre-op, 6 & 12 weeks post-op

Secondary Outcomes (3)

  • Knee flexion and extension range of motion during gait

    pre-op, 6 & 12 wks post-op

  • Sagittal plane laxity of the knee

    pre-op, 6 & 12 wks post-op

  • Isokinetic quadriceps and hamstrings strength

    pre-op and 12wks post-op

Study Arms (2)

Home-based

EXPERIMENTAL

Home-based post-operative rehabilitation program with 4 scheduled physiotherapy sessions over the first 3 post-op months

Procedure: Home-based rehabilitation program

Physiotherapy supervised

ACTIVE COMPARATOR

Physiotherapy-supervised rehabilitation program including 17 scheduled physiotherapy sessions in the first 3 post-op months

Procedure: Physiotherapy-supervised rehabilitation program

Interventions

Home-based rehabilitation programPROCEDURE

Home-based rehabilitation program that includes 4 physiotherapy sessions in the first 3 post-op months

Home-based
Physiotherapy-supervised rehabilitation programPROCEDURE

Physiotherapy-supervised rehabilitation program that includes 17 scheduled physiotherapy sessions in the first 3 post-op months

Physiotherapy supervised

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Surgery at least 6 weeks after injury to allow for a return of full range of motion, minimize swelling, and offset strength deficits due to pain/swelling14,28
  • ACL reconstruction with a bone-patellar tendon-bone autograft

You may not qualify if:

  • Previous or concomitant reconstruction of any knee ligament to either knee
  • Ongoing knee abnormality unrelated to the ACL injury (eg, evidence of changes on radiographs consistent with osteoarthritis)
  • Professional athletes or workers' compensation patients
  • Complications during surgery (eg, inadequate graft fixation requiring protocol modification)
  • Patients without access to local physical therapy services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary Sport Medicine Centre

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (1)

  • Grant JA, Mohtadi NG, Maitland ME, Zernicke RF. Comparison of home versus physical therapy-supervised rehabilitation programs after anterior cruciate ligament reconstruction: a randomized clinical trial. Am J Sports Med. 2005 Sep;33(9):1288-97. doi: 10.1177/0363546504273051. Epub 2005 Jul 7.

    PMID: 16002493RESULT

Study Officials

  • Nicholas G. Mohtadi, MD, MSc

    University of Calgary Sport Medicine Centre

    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

Study Record Dates

First Submitted

November 26, 2007

First Posted

November 28, 2007

Study Start

September 1, 1999

Primary Completion

February 1, 2001

Study Completion

February 1, 2001

Last Updated

January 12, 2010

Record last verified: 2010-01

Locations

CA(1)