ACTRN12606000389505RecruitingPhase 1
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).
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Queensland Health
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to ot stated (—)
- Sex
- All
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.
Investigators
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