Anterior Cruciate Ligament Injury
Conditions
Keywords
arthroscopy
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.
Interventions
PROCEDUREsingle-bundle, single-hamstring ACL reconstruction
anterior cruciate ligament reconstruction with single hamstring tendon
PROCEDUREsingle-bundle, double-hamstring ACL reconstruction
anterior cruciate ligament reconstruction with 2 hamstring tendons
Sponsors
Rafał Kamiński
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points | up to 5yrs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Knee injury and Osteoarthritis Outcome Score at up to 5yrs | up to 5yrs | Knee injury and Osteoarthritis Outcome Score minimum score:0, maximum score:100 Baltimore: Williams & Wilkins; 1994. p. 275-96. |
| Change from baseline Lysholm Knee Questionnaire at 104 weeks | up to 5yrs | 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. \[PubMed: 6896798\] |
| Change from baseline Visual Analog Scale for Pain at 104 weeks | up to 5yrs | 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. |
| Change from baseline International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at 104 weeks | up to 5yrs | Anderson, AF. Rating scales. In: Fu, FH.; Harner, CD.; Vince, KL., editors. Knee surgery. Baltimore: Williams & Wilkins; 1994. p. 275-96. |
| Change from baseline tunnel diameter at 104 weeks | 104-weeks postop | Change from baseline tunnel diameter will be calculated on standing knee x-rays at 104 weeks postoperatively |
| Need for arthrocentesis, revision surgery, additional procedures up to 104 weeks | up to 5yrs | 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. |
| Change from baseline tunnel volume at 104 weeks | 104-weeks postop | Change from baseline tunnel volume will be calculated on magnetic resonance imaging images at 104 weeks postoperatively |
Countries
Poland
Outcome results
None listed