Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction (1vs2ham)
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|ClinicalTrials.gov Identifier: NCT03626883|
Recruitment Status : Active, not recruiting
First Posted : August 13, 2018
Last Update Posted : April 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Injury||Procedure: single-bundle, single-hamstring ACL reconstruction Procedure: single-bundle, double-hamstring ACL reconstruction||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction. Clinical, Laboratory, Radiographic and Patient-reported Outcomes|
|Actual Study Start Date :||January 5, 2018|
|Actual Primary Completion Date :||January 30, 2020|
|Estimated Study Completion Date :||July 30, 2022|
Experimental: 1 hamstring
Patients will receive the intervention of 'single-bundle, single-hamstring ACL reconstruction'.
Procedure: single-bundle, single-hamstring ACL reconstruction
anterior cruciate ligament reconstruction with single hamstring tendon
Active Comparator: 2 hamstrings
Patients will receive the intervention of 'single-bundle, double-hamstring ACL reconstruction'.
Procedure: single-bundle, double-hamstring ACL reconstruction
anterior cruciate ligament reconstruction with 2 hamstring tendons
- Change from baseline Knee injury and Osteoarthritis Outcome Score at 104 weeks [ Time Frame: 104-weeks postop ]Knee injury and Osteoarthritis Outcome Score minimum score:0, maximum score:100 (full description available at koos.nu)
- Change from baseline International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at 104 weeks [ Time Frame: 104-weeks postop ]
Anderson, AF. Rating scales. In: Fu, FH.; Harner, CD.; Vince, KL., editors. Knee surgery.
Baltimore: Williams & Wilkins; 1994. p. 275-96.
- Change from baseline Tegner Activity Scale at 104 weeks [ Time Frame: 104-weeks postop ]Activity scale (patient-administered), minimum score: 0, maximum score: 10. Full description in: Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985; 198:43-9. [PubMed: 4028566]
- Change from baseline Lysholm Knee Questionnaire at 104 weeks [ Time Frame: 104-weeks postop ]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 [ Time Frame: 104-weeks postop ]
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 volume at 104 weeks [ Time Frame: 104-weeks postop ]Change from baseline tunnel volume will be calculated on magnetic resonance imaging images at 104 weeks postoperatively
- Change from baseline tunnel diameter at 104 weeks [ Time Frame: 104-weeks postop ]Change from baseline tunnel diameter will be calculated on standing knee x-rays at 104 weeks postoperatively
- Change from baseline knee stability at 104 weeks [ Time Frame: 104-weeks postop ]Change from baseline knee stability will be measured with KT-1000 arthrometer.
- Need for arthrocentesis, revision surgery, additional procedures up to 104 weeks [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626883
|Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education|
|Otwock, Woj. Mazowieckie, Poland, 05-400|
|Principal Investigator:||Marcin K Wasko, M.D., Ph.D.||The Medical Centre of Postgraduate Education in Warsaw|