An evaluation of knee stability and functions following ACL reconstruction (semitendinosus/gracillis grafts) comparing manually versus mechanically tensioned grafts (using a tensioning device).

Phase 1

Recruiting

• Conditions: Knees requiring ACL-Anterior Cruciate Ligament reconstruction; Musculoskeletal - Other surgery

• Registration Number: ACTRN12606000389505
• Lead Sponsor: Queensland Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.ACL integrity using the KT1000 (a measure of antero-posterior laxity). [Collected in the preoperative period, 2 weeks, 6 months, and 12 months post operatively];2.Functional Hop Test (a measure of confidence and function).[Measured only at Pre-op 6 and 12 months.]

Secondary Outcome Measures

Name	Time	Method
ysholm Knee Score, Tegner Activity Level, and the International Knee Documentation Committee (IKDC) Score.[Measured preoperatively (within 4 weeks), and postoperatively at 2 weeks 3, 6, and 12 months.]