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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
anterior cruciate ligament reconstruction with single hamstring tendon
anterior cruciate ligament reconstruction with 2 hamstring tendons
Prof. A. Gruca Teaching Hospital, Centre for Postgraduate Medical Education
Otwock, Woj. Mazowieckie, Poland
Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points
Time frame: up to 5yrs
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.
Time frame: 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.
Time frame: 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. \[PubMed: 6896798\]
Time frame: 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.
Time frame: up to 5yrs
Change from baseline tunnel volume at 104 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change from baseline tunnel volume will be calculated on magnetic resonance imaging images at 104 weeks postoperatively
Time frame: 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
Time frame: 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.
Time frame: up to 5yrs