Reduced Knee Flexion Strength 18 Years After ACL Reconstruction in Hamstring Group Compared to Patellar Tendon Group
NCT ID: NCT05876013
Last Updated: 2025-06-06
Study Results
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Basic Information
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COMPLETED
114 participants
OBSERVATIONAL
2022-03-14
2022-10-07
Brief Summary
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Purpose: To compare the results after using either BPTB grafts or hamstring grafts 18 years after ACL reconstruction.
Study design: Randomized controlled trial; Level of evidence II. Methods: 114 patients with ACL rupture between 2001 and 2004 were randomized to reconstruction with either BPTB graft or a hamstring graft. Patients were operated at four major hospitals. The 18-year follow-up evaluation included isokinetic testing of muscle strength, patient-reported outcome measures, clinical knee examination and an assessment of radiological osteoarthritis using the Kellgren-Lawrence classification.
Hypothesis:Hypothesis is that there will be no difference in the long-term outcome between the two groups, as well hypothesis of no difference in patients with prosthesis after ACL reconstruction, arthrosis difference in operated knees and the rate of graft failure between the two groups. Previous follow-up studies showed a significant difference in total flexion work between the two groups, so detecting a persistent difference between the groups will be point of interest.
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Detailed Description
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The aim of this prospective randomized multicenter study is to compare the use of bone-patellar tendon-bone (BPTB) grafts and double-looped semitendinosus gracilis (DLSG) grafts for reconstruction of the anterior cruciate ligament, 17-20 years after the surgery. The null hypothesis is that there will be no significant differences at this long-term follow-up evaluation between the two methods.
Method and material of the first study- Drogset et al. recruited 115 patients with rupture of the anterior cruciate ligament in the period of 2001-2004, and randomized them to either reconstruction with bone-patellar tendon-bone (BPTB) grafts fixed with metal interference screw graft, or double-looped semitendinosus gracilis (DLSG) grafts fixed with Bone Mulch Screws and WasherLoc Screws. The surgeries were performed at four different hospitals.
After one and two years, the patients were examined by an independent observer, using a series of objective tests, as well as recording the patients' subjective opinion of their knee function. The subjective tests used were Tegner's activity score, Lysholm's functional score and Modified Cincinnati Score. The objective tests used were Lachmann's test, pivot shift and KT-1000, as well as Cybex and Biodex to measure muscle strength.
Method and material- The present study is a long-term follow-up of a prospective randomized multicenter study. The patient recorded outcome scores will be Tegner's activity score, Lysholms's functional score and the Knee injury Osteoarthritis Outcome Score (KOOS). The examinations include Lachmann's test, pivot shift and KT-1000. We also plan to include radiographs to evaluate the degree of arthrosis 17-20 years after the surgery, and Cybex or Biodex to examine the hamstring and quadriceps strength. The radiographic positioning will be knee AP weight-bearing standing bilateral and lateral view, as well as skyline projection. The Kellgren-Lawrence classification will be used to assess the degree of osteoarthritis.
Even though 115 patients were included in the original study, we will only attempt to contact 114 due to lost inclusion-papers between the 2-year and 7-year follow-up \[8\]. During the spring of 2022, the patients will receive an invite to participate in the follow-up study. Following this, patients will be contacted to uncover different circumstances that might exclude certain patients from the clinical assessment. This includes revision of the reconstruction in question, total knee replacement or total knee arthroplasty, and if the knee had been injured beforehand. The clinical examination will be carried out by both a medical student and an experienced orthopedic surgeon. Hopefully all the patients will be examined over the course of two days at each location, and if needed, the rest will be examined at a later date.
Hypothesis- Current hypothesis is that there will be no difference in the long-term outcome between the two groups. However, it will be interesting to see how many patients have received a prosthesis, and how many patients struggle with arthrosis. As the previous follow-up studies showed a significant difference in total flexion work between the two groups, we will be interested in detecting a persistent difference between the groups.
Another interesting aspect will be the rate of graft failure between the two groups.
Feasibility- The strength of the study is the randomization and the long follow-up period of 17-20 years. The possible limitations are the fact that there may be a problem recruiting enough patients to the follow-up, and that it might not be able to get x-rays of the patients at the different hospitals, as this is a matter of cost and availability. In addition, the different hospitals may not have a Biodex available.
Publicity plan- The goal for the paper is to be published in an international journal and probably be presented at conferences. For article, that hopefully will be published in journals, Marko Popovic will stand as first author, and Julie Holen and Julie Myhre as contributing authors. Jon Olav Drogset will be listed last, as the main supervisor.
Ethics- The REK-application was submitted on the 24th of December 2021. Application number: 391796. Additionally, the project will be reported to NSD when the REK-application is approved.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BPTB group
Bone-patellar tendon- bone graft used for ACL reconstruction.
ACL reconstruction
Randomized between hamstring and patellar tendon graft
Hamstring group
Double-looped semitendinosus and gracilis graft used for ACL reconstruction
ACL reconstruction
Randomized between hamstring and patellar tendon graft
Interventions
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ACL reconstruction
Randomized between hamstring and patellar tendon graft
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient must understand and accept the written consent. The written consent must be signed by the patient before surgery.
* Normal two-plane X-ray of the knee.
Exclusion Criteria
* Patient with major additional injury in the knee: combined instability, cartilage injuries Outerbridge grade 3-4 and at least 1cm in diameter on the femoral condyle and major meniscal lesions with meniscal repairs.
* Patients having problems following the protocol.
* The patient does not understand the written consent or will not sign it.
* Patients with a history of alcohol or drug abuse the last three years.
* The patient has received any investigational drugs within 30 days prior to admittance to this study.
* The patient has O.A., podagra, RA, Bechterew's disease or chondrocalcinosis.
* The patient has malalignment with more than 5 degrees valgus and no varus compared to a normal knee.
* The patient has patellofemoral instability.
* The patient is obese with BMI\>30.
* The patient has a present or former serious illness that makes follow-up or rehabilitation of the patient difficult.
* Former major surgical procedures in the same knee, including prosthesis.
* Treated or untreated anterior cruciate ligament injury in the other knee.
18 Years
45 Years
ALL
No
Sponsors
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Lovisenberg Diakonale Hospital
OTHER
Haraldsplass Deaconess Hospital
OTHER
St. Olavs Hospital
OTHER
Responsible Party
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Principal Investigators
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Jon O. Drogset, PhD
Role: STUDY_CHAIR
St Olav Hospital Trondheim
Locations
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St Olav Hospital
Trondheim, Trøndelag, Norway
Countries
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References
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Bourke HE, Salmon LJ, Waller A, Patterson V, Pinczewski LA. Survival of the anterior cruciate ligament graft and the contralateral ACL at a minimum of 15 years. Am J Sports Med. 2012 Sep;40(9):1985-92. doi: 10.1177/0363546512454414. Epub 2012 Aug 6.
Leys T, Salmon L, Waller A, Linklater J, Pinczewski L. Clinical results and risk factors for reinjury 15 years after anterior cruciate ligament reconstruction: a prospective study of hamstring and patellar tendon grafts. Am J Sports Med. 2012 Mar;40(3):595-605. doi: 10.1177/0363546511430375. Epub 2011 Dec 19.
Freedman KB, D'Amato MJ, Nedeff DD, Kaz A, Bach BR Jr. Arthroscopic anterior cruciate ligament reconstruction: a metaanalysis comparing patellar tendon and hamstring tendon autografts. Am J Sports Med. 2003 Jan-Feb;31(1):2-11. doi: 10.1177/03635465030310011501.
Gifstad T, Foss OA, Engebretsen L, Lind M, Forssblad M, Albrektsen G, Drogset JO. Lower risk of revision with patellar tendon autografts compared with hamstring autografts: a registry study based on 45,998 primary ACL reconstructions in Scandinavia. Am J Sports Med. 2014 Oct;42(10):2319-28. doi: 10.1177/0363546514548164. Epub 2014 Sep 8.
Gifstad T, Sole A, Strand T, Uppheim G, Grontvedt T, Drogset JO. Long-term follow-up of patellar tendon grafts or hamstring tendon grafts in endoscopic ACL reconstructions. Knee Surg Sports Traumatol Arthrosc. 2013 Mar;21(3):576-83. doi: 10.1007/s00167-012-1947-0. Epub 2012 Mar 10.
Drogset JO, Strand T, Uppheim G, Odegard B, Boe A, Grontvedt T. Autologous patellar tendon and quadrupled hamstring grafts in anterior cruciate ligament reconstruction: a prospective randomized multicenter review of different fixation methods. Knee Surg Sports Traumatol Arthrosc. 2010 Aug;18(8):1085-93. doi: 10.1007/s00167-009-0996-5. Epub 2009 Dec 3.
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Costa-Paz M, Garcia-Mansilla I, Marciano S, Ayerza MA, Muscolo DL. Knee-related quality of life, functional results and osteoarthritis at a minimum of 20 years' follow-up after anterior cruciate ligament reconstruction. Knee. 2019 Jun;26(3):666-672. doi: 10.1016/j.knee.2019.04.010. Epub 2019 May 15.
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Persson A, Fjeldsgaard K, Gjertsen JE, Kjellsen AB, Engebretsen L, Hole RM, Fevang JM. Increased risk of revision with hamstring tendon grafts compared with patellar tendon grafts after anterior cruciate ligament reconstruction: a study of 12,643 patients from the Norwegian Cruciate Ligament Registry, 2004-2012. Am J Sports Med. 2014 Feb;42(2):285-91. doi: 10.1177/0363546513511419. Epub 2013 Dec 9.
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Holm I, Oiestad BE, Risberg MA, Aune AK. No difference in knee function or prevalence of osteoarthritis after reconstruction of the anterior cruciate ligament with 4-strand hamstring autograft versus patellar tendon-bone autograft: a randomized study with 10-year follow-up. Am J Sports Med. 2010 Mar;38(3):448-54. doi: 10.1177/0363546509350301. Epub 2010 Jan 23.
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Popovic M, Myhre JR, Holen JIH, Gifstad T, Strand IL, Strand T, Mo IF, Fischer-Bredenbeck C, Drogset JO. Reduced Knee Flexion Strength 18 Years After ACL Reconstruction With Hamstring Tendon Versus Patellar Tendon. Am J Sports Med. 2024 Sep;52(11):2750-2757. doi: 10.1177/03635465241271524. Epub 2024 Sep 2.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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391796
Identifier Type: -
Identifier Source: org_study_id
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