Condition category
Injury, Occupational Diseases, Poisoning
Date applied
12/01/2011
Date assigned
31/01/2011
Last edited
30/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Shahril Shaarani

ORCID ID

Contact details

Cappagh National Orthopaedic Hospital
Finglas
Dublin
11
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of prehabilitation on the outcome of anterior cruciate ligament reconstruction: a two centre prospective, single surgeon, randomly allocated study

Acronym

Study hypothesis

To determine whether prehabilitation would result in equal quadriceps strength 3 month post anterior cruciate ligament (ACL) reconstruction.

As of 20/09/2011 the anticipated end date for this trial has been extended from 30/06/2011 to 30/06/2012.

Ethics approval

1. Cappagh National Orthopaedic Hospital Research Ethics Committee approved on the 1st December 2009 (ref: JOB.10.2009.28)
2. Sports Surgery Clinic Research and Ethics Committee approved on the 8th February 2010

Study design

Single surgeon multicentre prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Anterior cruciate ligament tear

Intervention

This interventional trial will recruit 30 patients: 15 in the prehabilitation exercise group, 15 control patients recieving standard pre- and post-operative care. The prehabilitation group will recieve 6 weeks pre-operative physiotherapy programme comprising of 2 gym and 2 home sessions per week.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Isokinetic quadriceps strength testing
2. Magnetic resonance imaging cross-sectional area of the quadriceps (MRI CSA)
3. Physical performance test: single leg hop test and in-line lunge
4. Disease specific questionnaire: Modified Cincinnatti Knee Score, Tegner Lysholm Knee Score, Tegnaer Activity Scale
5. Muscle biopsy of quadriceps: looking for down-regulation of muscle atrophy genes and up-regulation in IGF-1 pathways in muscle hypertrophy
Patients will undergo all the above test at time of recruitment, 6 weeks post exercise and 3 months postoperatively.

6. Time to return to sports activities

Secondary outcome measures

1. To determine the effect of a pre-operative exercise programme on isokinetic hamstring strength
2. To assess the validity, reliability and responsiveness of:
2.1. Isokinetic dynamometry
2.2. Physical performance tests
2.3. Questionnaires

Overall trial start date

13/01/2011

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with isolated anterior cruciate ligament tear
2. Males aged 18 - 40 years

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

30

Participant exclusion criteria

1. Patients with age less than 18 or over 40 years
2. Patients living outside Greater Dublin area (for practical reasons regarding exercise supervision)
3. Patients with associated fractures, meniscal repair and collateral ligament injury
4. Patients with co-morbidities (contra-indication to relatively high physical exertion)

Recruitment start date

13/01/2011

Recruitment end date

30/06/2012

Locations

Countries of recruitment

Ireland

Trial participating centre

Cappagh National Orthopaedic Hospital
Dublin
11
Ireland

Sponsor information

Organisation

Cappagh National Orthopaedic Hospital (Ireland)

Sponsor details

Finglas
Dublin
11
Ireland

Sponsor type

Hospital/treatment centre

Website

http://www.cappagh.ie

Funders

Funder type

Other

Funder name

Investigator initated and funded (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23845398

Publication citations

  1. Results

    Shaarani SR, O'Hare C, Quinn A, Moyna N, Moran R, O'Byrne JM, Effect of prehabilitation on the outcome of anterior cruciate ligament reconstruction., Am J Sports Med, 2013, 41, 9, 2117-2127, doi: 10.1177/0363546513493594.

Additional files

Editorial Notes