Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction. Clinical, Laboratory, Radiographic and Patient-reported Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points
Study Overview
Brief Summary
The aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective and objective outcomes of primary anterior cruciate ligament reconstruction.
Detailed Description
The aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective (patient-reported outcome measures) and objective (instrument-tested and imaging studies) outcomes of primary anterior cruciate ligament reconstruction.
The study will recruit 60 patients per each of two arms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •chronic anterior knee instability with MRI-confirmed anterior cruciate ligament tear
Exclusion Criteria
- •revision anterior cruciate ligament surgery
- •other lower limb injuries
Outcomes
Primary Outcomes
Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points
Time Frame: up to 5yrs
Secondary Outcomes
- Change from baseline Lysholm Knee Questionnaire at 104 weeks(up to 5yrs)
- Need for arthrocentesis, revision surgery, additional procedures up to 104 weeks(up to 5yrs)
- Change from baseline tunnel volume at 104 weeks(104-weeks postop)
- Change from baseline tunnel diameter at 104 weeks(104-weeks postop)
- Change from baseline International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at 104 weeks(up to 5yrs)
- Change from baseline Knee injury and Osteoarthritis Outcome Score at up to 5yrs(up to 5yrs)
- Change from baseline Visual Analog Scale for Pain at 104 weeks(up to 5yrs)
Investigators
Rafał Kamiński
MD, PhD
Centre of Postgraduate Medical Education
