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Trial registered on ANZCTR


Registration number
ACTRN12606000389505
Ethics application status
Approved
Date submitted
28/08/2006
Date registered
5/09/2006
Date last updated
4/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of knee stability and functions following ACL reconstruction (semitendinosus/gracillis grafts) comparing manually versus mechanically tensioned grafts (using a tensioning device).
Scientific title
An evaluation of knee stability and functions following Anterior Cruciate Ligament (ACL) reconstruction (semitendinosus/gracillis grafts) comparing manually versus mechanically tensioned grafts (using a tensioning device).
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knees requiring ACL-Anterior Cruciate Ligament reconstruction 1355 0
Condition category
Condition code
Musculoskeletal 1446 1446 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two tensioning methods for ACL reconstruction will be used: 1.Manual Tensioning (control group-semitendinosus/gracillis grafts) 2.Tensioning with a Graft Tensioner (intervention group-a tensioning device). Both groups will follow the same postoperative protocols.

Estimated time for procedure 70 mins

Surgical protocol
Tensioning Device Intervention Group:
The graft is fixed to the tensioning device via suture tying
The grafts are tensioned to 60 N for Semitendinosis and 40 Nfor gracillis
The knee is cycled 15 times through full range of motion
The tension is checked and adjusted so that 50 N remain on the semitendinosis graft and 30 N on the gracillis graft
The tibial screw is then fixed in situ with the tension maintained
The femoral fixation will be standardised

Post Operative Management
Both groups will be reconstructed using the semitendinosus/gracilis graft. The same postoperative protocols will be adhered to which involves an accelerated rehabilitation approach. The aim of this protocol is normal gait no aids by 2 weeks, normal range of movement, and minimal swelling within 6 weeks, and the aim of returning to sport in 6-9 months. Patients will be assessed preoperatively, and at 2 weeks, 3, 6 and 12 months post operatively using the measures outlined above.
Intervention code [1] 1333 0
Treatment: Surgery
Comparator / control treatment

Manually Tensioned Control Group:
Tension and fixation will follow the accepted standard practice of graft fixation
The sutures on the end of the hamstring grafts will be held by the surgeon with force applied whilst the knee is cycled 15 times through a full range of motion
The tibial screw will be fixed in situ with the manually applied tension
The femoral fixation is standardised
Control group
Active

Outcomes
Primary outcome [1] 1996 0
1.ACL integrity using the KT1000 (a measure of antero-posterior laxity).
Timepoint [1] 1996 0
Collected in the preoperative period, 2 weeks, 6 months, and 12 months post operatively
Primary outcome [2] 1997 0
2.Functional Hop Test (a measure of confidence and function).
Timepoint [2] 1997 0
Measured only at Pre-op 6 and 12 months.
Secondary outcome [1] 3458 0
Lysholm Knee Score, Tegner Activity Level, and the International Knee Documentation Committee (IKDC) Score.
Timepoint [1] 3458 0
Measured preoperatively (within 4 weeks), and postoperatively at 2 weeks 3, 6, and 12 months.

Eligibility
Key inclusion criteria
Adult participants.The expected age range of subjects undergoing ACL surgery is between 18-40 years.Patients undergoing primary ACL reconstructionDiagnosis of ACL ruptureHealthy and no comorbidities that would prevent participating in the required rehabilitation programmeNormal mentation with the ability to accurately follow commandsAbility to participate voluntarily and provide signed informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Persons with concomitant medical conditions such as malignant tumours or severe Chronic Obstructive Pulmonary Disease that would prevent participation in their rehabilitation programmeInability to follow commandsPersons not able to mobilise in a bipedal manner with or without a walking aid.Conditions preventing full weight bearing post-operativelyThe inability to provide signed informed consentRevision ACL or any previous major arthrotomy on the knee to be operated onPersons not suitable for a gracilis/semitendinosus graftConcomitant meniscal or collateral ligament injuries or any lower limb injury affecting the knee.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation. Ratio 1:1
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Physiotherapist blind to intervention collects all measures at each assessment point. Participants blinded to intervention. Surgeon not involved in data collection.
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1584 0
Government body
Name [1] 1584 0
Queensland Health
Country [1] 1584 0
Australia
Primary sponsor type
Government body
Name
Queensland Health
Address
QLD Health - QEII Jubilee Hospital
Kessels Rd
Nathan, Brisbane QLD
Country
Australia
Secondary sponsor category [1] 1391 0
None
Name [1] 1391 0
Nil
Address [1] 1391 0
Country [1] 1391 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3009 0
088/060
Ethics committee address [1] 3009 0
Ethics committee country [1] 3009 0
Australia
Date submitted for ethics approval [1] 3009 0
Approval date [1] 3009 0
25/05/2006
Ethics approval number [1] 3009 0
2006/072

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27940 0
Address 27940 0
Country 27940 0
Phone 27940 0
Fax 27940 0
Email 27940 0
Contact person for public queries
Name 10522 0
Michael Bourke
Address 10522 0
QEII Jubile Hospital
PMB 2
Acacia Ridge
Brisbane QLD 4110
Country 10522 0
Australia
Phone 10522 0
+61 7 32756173
Fax 10522 0
+61 7 32756579
Email 10522 0
michael_bourke@health.qld.gov.au
Contact person for scientific queries
Name 1450 0
Garry Kirwan
Address 1450 0
QEII Jubile Hospital
PMB 2
Acacia Ridge
Brisbane QLD 4110
Country 1450 0
Australia
Phone 1450 0
+61 7 32756331
Fax 1450 0
+61 7 32756579
Email 1450 0
garry_kirwan@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.