Repair versus reconstruction for proximal anterior cruciate ligament tears: a study protocol for a prospective multicenter randomized controlled trial
Abstract Background For active patients with a tear of the anterior cruciate ligament (ACL) who would like to return to active level of sports, the current surgical gold standard is reconstruction of the ACL. Recently, there has been renewed interest in repairing the ACL in selected patients with a...
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| Format: | Article |
| Language: | English |
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BMC
2021-04-01
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| Series: | BMC Musculoskeletal Disorders |
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| Online Access: | https://doi.org/10.1186/s12891-021-04280-y |
| _version_ | 1818561803380064256 |
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| author | Jelle P. van der List Harmen D. Vermeijden Inger N. Sierevelt Maarten V. Rademakers Mark L. M. Falke Gijs T. T. Helmerhorst Roy A. G. Hoogeslag Wybren A. van der Wal Arthur van Noort Gino M. M. J. Kerkhoffs |
| author_facet | Jelle P. van der List Harmen D. Vermeijden Inger N. Sierevelt Maarten V. Rademakers Mark L. M. Falke Gijs T. T. Helmerhorst Roy A. G. Hoogeslag Wybren A. van der Wal Arthur van Noort Gino M. M. J. Kerkhoffs |
| author_sort | Jelle P. van der List |
| collection | DOAJ |
| description | Abstract Background For active patients with a tear of the anterior cruciate ligament (ACL) who would like to return to active level of sports, the current surgical gold standard is reconstruction of the ACL. Recently, there has been renewed interest in repairing the ACL in selected patients with a proximally torn ligament. Repair of the ligament has (potential) advantages over reconstruction of the ligament such as decreased surgical morbidity, faster return of range of motion, and potentially decreased awareness of the knee. Studies comparing both treatments in a prospective randomized method are currently lacking. Methods This study is a multicenter prospective block randomized controlled trial. A total of 74 patients with acute proximal isolated ACL tears will be assigned in a 1:1 allocation ratio to either (I) ACL repair using cortical button fixation and additional suture augmentation or (II) ACL reconstruction using an all-inside autologous hamstring graft technique. The primary objective is to assess if ACL repair is non-inferior to ACL reconstruction regarding the subjective International Knee Documentation Committee (IKDC) score at two-years postoperatively. The secondary objectives are to assess if ACL repair is non-inferior with regards to (I) other patient-reported outcomes measures (i.e. Knee Injury and Osteoarthritis Outcome Score, Lysholm score, Forgotten Joint Score, patient satisfaction and pain), (II) objective outcome measures (i.e. failure of repair or graft defined as rerupture or symptomatic instability, reoperation, contralateral injury, and stability using the objective IKDC score and Rollimeter/KT-2000), (III) return to sports assessed by Tegner activity score and the ACL-Return to Sports Index at two-year follow-up, and (IV) long-term osteoarthritis at 10-year follow-up. Discussion Over the last decade there has been a resurgence of interest in repair of proximally torn ACLs. Several cohort studies have shown encouraging short-term and mid-term results using these techniques, but prospective randomized studies are lacking. Therefore, this randomized controlled trial has been designed to assess whether ACL repair is at least equivalent to the current gold standard of ACL reconstruction in both subjective and objective outcome scores. Trial registration Registered at Netherlands Trial Register ( NL9072 ) on 25th of November 2020. |
| first_indexed | 2024-12-14T00:55:30Z |
| format | Article |
| id | doaj.art-90ff73278dbe4a6c8a4fb2df5e76b4f7 |
| institution | Directory Open Access Journal |
| issn | 1471-2474 |
| language | English |
| last_indexed | 2024-12-14T00:55:30Z |
| publishDate | 2021-04-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Musculoskeletal Disorders |
| spelling | doaj.art-90ff73278dbe4a6c8a4fb2df5e76b4f72022-12-21T23:23:36ZengBMCBMC Musculoskeletal Disorders1471-24742021-04-0122111010.1186/s12891-021-04280-yRepair versus reconstruction for proximal anterior cruciate ligament tears: a study protocol for a prospective multicenter randomized controlled trialJelle P. van der List0Harmen D. Vermeijden1Inger N. Sierevelt2Maarten V. Rademakers3Mark L. M. Falke4Gijs T. T. Helmerhorst5Roy A. G. Hoogeslag6Wybren A. van der Wal7Arthur van Noort8Gino M. M. J. Kerkhoffs9Department of Orthopaedic Surgery, Amsterdam UMC, University of AmsterdamOrthopaedic Trauma Service, Department of Orthopaedic Surgery, Hospital for Special SurgeryDepartment of Orthopaedic Surgery, Amsterdam UMC, University of AmsterdamDepartment of Orthopaedic Surgery, Spaarne GasthuisDepartment of Orthopaedic Surgery, FlevoziekenhuisDepartment of Orthopaedic Surgery, FlevoziekenhuisDepartment of Orthopaedic Surgery, Centre for Orthopaedic Surgery OCONDepartment of Orthopaedic Surgery, Ziekenhuis Gelderse ValleiDepartment of Orthopaedic Surgery, Spaarne GasthuisDepartment of Orthopaedic Surgery, Amsterdam UMC, University of AmsterdamAbstract Background For active patients with a tear of the anterior cruciate ligament (ACL) who would like to return to active level of sports, the current surgical gold standard is reconstruction of the ACL. Recently, there has been renewed interest in repairing the ACL in selected patients with a proximally torn ligament. Repair of the ligament has (potential) advantages over reconstruction of the ligament such as decreased surgical morbidity, faster return of range of motion, and potentially decreased awareness of the knee. Studies comparing both treatments in a prospective randomized method are currently lacking. Methods This study is a multicenter prospective block randomized controlled trial. A total of 74 patients with acute proximal isolated ACL tears will be assigned in a 1:1 allocation ratio to either (I) ACL repair using cortical button fixation and additional suture augmentation or (II) ACL reconstruction using an all-inside autologous hamstring graft technique. The primary objective is to assess if ACL repair is non-inferior to ACL reconstruction regarding the subjective International Knee Documentation Committee (IKDC) score at two-years postoperatively. The secondary objectives are to assess if ACL repair is non-inferior with regards to (I) other patient-reported outcomes measures (i.e. Knee Injury and Osteoarthritis Outcome Score, Lysholm score, Forgotten Joint Score, patient satisfaction and pain), (II) objective outcome measures (i.e. failure of repair or graft defined as rerupture or symptomatic instability, reoperation, contralateral injury, and stability using the objective IKDC score and Rollimeter/KT-2000), (III) return to sports assessed by Tegner activity score and the ACL-Return to Sports Index at two-year follow-up, and (IV) long-term osteoarthritis at 10-year follow-up. Discussion Over the last decade there has been a resurgence of interest in repair of proximally torn ACLs. Several cohort studies have shown encouraging short-term and mid-term results using these techniques, but prospective randomized studies are lacking. Therefore, this randomized controlled trial has been designed to assess whether ACL repair is at least equivalent to the current gold standard of ACL reconstruction in both subjective and objective outcome scores. Trial registration Registered at Netherlands Trial Register ( NL9072 ) on 25th of November 2020.https://doi.org/10.1186/s12891-021-04280-yAnterior cruciate ligamentAnterior cruciate ligament reconstructionAnterior cruciate ligament repairPrimary repairProximal tearKnee injury |
| spellingShingle | Jelle P. van der List Harmen D. Vermeijden Inger N. Sierevelt Maarten V. Rademakers Mark L. M. Falke Gijs T. T. Helmerhorst Roy A. G. Hoogeslag Wybren A. van der Wal Arthur van Noort Gino M. M. J. Kerkhoffs Repair versus reconstruction for proximal anterior cruciate ligament tears: a study protocol for a prospective multicenter randomized controlled trial BMC Musculoskeletal Disorders Anterior cruciate ligament Anterior cruciate ligament reconstruction Anterior cruciate ligament repair Primary repair Proximal tear Knee injury |
| title | Repair versus reconstruction for proximal anterior cruciate ligament tears: a study protocol for a prospective multicenter randomized controlled trial |
| title_full | Repair versus reconstruction for proximal anterior cruciate ligament tears: a study protocol for a prospective multicenter randomized controlled trial |
| title_fullStr | Repair versus reconstruction for proximal anterior cruciate ligament tears: a study protocol for a prospective multicenter randomized controlled trial |
| title_full_unstemmed | Repair versus reconstruction for proximal anterior cruciate ligament tears: a study protocol for a prospective multicenter randomized controlled trial |
| title_short | Repair versus reconstruction for proximal anterior cruciate ligament tears: a study protocol for a prospective multicenter randomized controlled trial |
| title_sort | repair versus reconstruction for proximal anterior cruciate ligament tears a study protocol for a prospective multicenter randomized controlled trial |
| topic | Anterior cruciate ligament Anterior cruciate ligament reconstruction Anterior cruciate ligament repair Primary repair Proximal tear Knee injury |
| url | https://doi.org/10.1186/s12891-021-04280-y |
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