Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction
- Conditions
- Anterior Cruciate Ligament Injury
- Interventions
- Procedure: single-bundle, single-hamstring ACL reconstructionProcedure: single-bundle, double-hamstring ACL reconstruction
- Registration Number
- NCT03626883
- Lead Sponsor
- Rafał Kamiński
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- chronic anterior knee instability with MRI-confirmed anterior cruciate ligament tear
- revision anterior cruciate ligament surgery
- other lower limb injuries
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 hamstring single-bundle, single-hamstring ACL reconstruction Patients will receive the intervention of 'single-bundle, single-hamstring ACL reconstruction'. 2 hamstrings single-bundle, double-hamstring ACL reconstruction Patients will receive the intervention of 'single-bundle, double-hamstring ACL reconstruction'.
- Primary Outcome Measures
Name Time Method Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points up to 5yrs
- Secondary Outcome Measures
Name Time Method 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. \[PubMed: 6896798\]
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
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 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 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 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
Trial Locations
- Locations (1)
Prof. A. Gruca Teaching Hospital, Centre for Postgraduate Medical Education
🇵🇱Otwock, Woj. Mazowieckie, Poland