Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction. Clinical, Laboratory, Radiographic and Patient-reported Outcomes

Conditions
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Anterior Cruciate Ligament Injury

Intervention / Treatment
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* Procedure: single-bundle, single-hamstring ACL reconstruction
* Procedure: single-bundle, double-hamstring ACL reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic anterior knee instability with MRI-confirmed anterior cruciate ligament tear Exclusion Criteria: revision anterior cruciate ligament surgery other lower limb injuries

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 hamstring<br>Patients will receive the intervention of 'single-bundle, single-hamstring ACL reconstruction'. | Procedure: single-bundle, single-hamstring ACL reconstruction<br>* anterior cruciate ligament reconstruction with single hamstring tendon<br>|
| Active Comparator: 2 hamstrings<br>Patients will receive the intervention of 'single-bundle, double-hamstring ACL reconstruction'. | Procedure: single-bundle, double-hamstring ACL reconstruction<br>* anterior cruciate ligament reconstruction with 2 hamstring tendons<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points |  | up to 5yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at 104 weeks | Anderson, AF. Rating scales. In: Fu, FH.; Harner, CD.; Vince, KL., editors. Knee surgery. Baltimore: Williams & Wilkins; 1994. p. 275-96. | up to 5yrs | 
| Change from baseline Knee injury and Osteoarthritis Outcome Score at up to 5yrs | Knee injury and Osteoarthritis Outcome Score minimum score:0, maximum score:100 Baltimore: Williams & Wilkins; 1994. p. 275-96. | up to 5yrs | 
| Change from baseline Lysholm Knee Questionnaire at 104 weeks | Knee function questionnaire (patient-administered), minimum score: 0, maximum score: 100. Full description in: Lysholm J, Gillquist J. Evaluation of knee ligament surgery results with special emphasis on use of a scoring scale. Am J Sports Med. 1982; 10:150-4. [PubMed: 6896798] | up to 5yrs | 
| Change from baseline Visual Analog Scale for Pain at 104 weeks | Separate Outcome Measure, with minimum 0 and maximum of 10. Full description in: Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi:10.1002/acr.20543. | up to 5yrs | 
| Change from baseline tunnel volume at 104 weeks | Change from baseline tunnel volume will be calculated on magnetic resonance imaging images at 104 weeks postoperatively | 104-weeks postop | 
| Change from baseline tunnel diameter at 104 weeks | Change from baseline tunnel diameter will be calculated on standing knee x-rays at 104 weeks postoperatively | 104-weeks postop | 
| Need for arthrocentesis, revision surgery, additional procedures up to 104 weeks | The medical records will be prospectively abstracted and analyzed for any arthrocentesis, revision surgery or additional procedures performed in the study group up top 104 weeks after index surgery. | up to 5yrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arthroscopy