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

Results pending

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-14

Study Completion Date

2022-10-07

Brief Summary

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Background: Bone-patellar tendon-bone (BPTB) and a double-looped semitendinosus gracilis (hamstring group) graft are commonly used for ACL reconstruction. Short-term and mid-term studies show little to no significant difference between the two groups, and there are a few long term studies to compare results between the two grafts.

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.

Detailed Description

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Introduction Rupture of the anterior cruciate ligament (ACL) is a common soft-tissue knee injury, and has increased in number over the last twenty years. Reconstructing the ligament may be important for maintaining the stability and preventing further damaging of the knee. The two most commonly used grafts in reconstructions are the autologous patellar tendon grafts and hamstring tendon grafts There is yet to be a universally established agreement regarding which reconstruction method of an ACL is preferred. The method using the central third of the patellar tendon with proximal and distal bone blocks as the replacement has been used since the late 80s and is well documented with good results. When the technique using the hamstring tendon grafts was introduced, its popularity increased. Arguments favoring each of the methods depend on which variables one values the most. In some studies, the patellar tendon group reported problems regarding anterior knee pain and decreased sensitivity of the knee, whereas for the hamstring tendon group there was reported increased weakness of the hamstring muscles and knee laxity. However, the overall assessment and satisfaction in multiple short-term/semi-long studies have shown little to no difference .

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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ACL ACL Injury Cruciate Ligament Rupture ACL Tear Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BPTB group

Bone-patellar tendon- bone graft used for ACL reconstruction.

ACL reconstruction

Intervention Type PROCEDURE

Randomized between hamstring and patellar tendon graft

Hamstring group

Double-looped semitendinosus and gracilis graft used for ACL reconstruction

ACL reconstruction

Intervention Type PROCEDURE

Randomized between hamstring and patellar tendon graft

Interventions

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ACL reconstruction

Randomized between hamstring and patellar tendon graft

Intervention Type PROCEDURE

Other Intervention Names

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Graft choice,

Eligibility Criteria

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Inclusion Criteria

* Primary reconstructions of isolated ACL-ruptures. Surgery at least 6 weeks after injury. Age 18-45 years.
* 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

-\>5mm + chronic MCL-injury in the same knee.

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lovisenberg Diakonale Hospital

OTHER

Sponsor Role collaborator

Haraldsplass Deaconess Hospital

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Norway

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.

Reference Type BACKGROUND
PMID: 22869626 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22184280 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12531750 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25201444 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22407182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19956928 (View on PubMed)

Herzog MM, Marshall SW, Lund JL, Pate V, Mack CD, Spang JT. Trends in Incidence of ACL Reconstruction and Concomitant Procedures Among Commercially Insured Individuals in the United States, 2002-2014. Sports Health. 2018 Nov/Dec;10(6):523-531. doi: 10.1177/1941738118803616.

Reference Type BACKGROUND
PMID: 30355175 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31103415 (View on PubMed)

Risberg MA, Oiestad BE, Gunderson R, Aune AK, Engebretsen L, Culvenor A, Holm I. Changes in Knee Osteoarthritis, Symptoms, and Function After Anterior Cruciate Ligament Reconstruction: A 20-Year Prospective Follow-up Study. Am J Sports Med. 2016 May;44(5):1215-24. doi: 10.1177/0363546515626539. Epub 2016 Feb 24.

Reference Type BACKGROUND
PMID: 26912282 (View on PubMed)

Mohtadi NG, Chan DS, Dainty KN, Whelan DB. Patellar tendon versus hamstring tendon autograft for anterior cruciate ligament rupture in adults. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD005960. doi: 10.1002/14651858.CD005960.pub2.

Reference Type BACKGROUND
PMID: 21901700 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24322979 (View on PubMed)

Goldblatt JP, Fitzsimmons SE, Balk E, Richmond JC. Reconstruction of the anterior cruciate ligament: meta-analysis of patellar tendon versus hamstring tendon autograft. Arthroscopy. 2005 Jul;21(7):791-803. doi: 10.1016/j.arthro.2005.04.107.

Reference Type BACKGROUND
PMID: 16012491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20097928 (View on PubMed)

Mascarenhas R, Tranovich MJ, Kropf EJ, Fu FH, Harner CD. Bone-patellar tendon-bone autograft versus hamstring autograft anterior cruciate ligament reconstruction in the young athlete: a retrospective matched analysis with 2-10 year follow-up. Knee Surg Sports Traumatol Arthrosc. 2012 Aug;20(8):1520-7. doi: 10.1007/s00167-011-1735-2. Epub 2011 Nov 3.

Reference Type BACKGROUND
PMID: 22048746 (View on PubMed)

Sajovic M, Vengust V, Komadina R, Tavcar R, Skaza K. A prospective, randomized comparison of semitendinosus and gracilis tendon versus patellar tendon autografts for anterior cruciate ligament reconstruction: five-year follow-up. Am J Sports Med. 2006 Dec;34(12):1933-40. doi: 10.1177/0363546506290726. Epub 2006 Aug 21.

Reference Type BACKGROUND
PMID: 16923826 (View on PubMed)

Xie X, Liu X, Chen Z, Yu Y, Peng S, Li Q. A meta-analysis of bone-patellar tendon-bone autograft versus four-strand hamstring tendon autograft for anterior cruciate ligament reconstruction. Knee. 2015 Mar;22(2):100-10. doi: 10.1016/j.knee.2014.11.014. Epub 2014 Dec 11.

Reference Type BACKGROUND
PMID: 25547048 (View on PubMed)

Bjornsson H, Samuelsson K, Sundemo D, Desai N, Sernert N, Rostgard-Christensen L, Karlsson J, Kartus J. A Randomized Controlled Trial With Mean 16-Year Follow-up Comparing Hamstring and Patellar Tendon Autografts in Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2016 Sep;44(9):2304-13. doi: 10.1177/0363546516646378. Epub 2016 May 26.

Reference Type BACKGROUND
PMID: 27229354 (View on PubMed)

Coffey R, Bordoni B. Lachman Test. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554415/

Reference Type BACKGROUND
PMID: 32119302 (View on PubMed)

Sajovic M, Stropnik D, Skaza K. Long-term Comparison of Semitendinosus and Gracilis Tendon Versus Patellar Tendon Autografts for Anterior Cruciate Ligament Reconstruction: A 17-Year Follow-up of a Randomized Controlled Trial. Am J Sports Med. 2018 Jul;46(8):1800-1808. doi: 10.1177/0363546518768768. Epub 2018 May 9.

Reference Type BACKGROUND
PMID: 29741911 (View on PubMed)

Vaudreuil NJ, Rothrauff BB, de Sa D, Musahl V. The Pivot Shift: Current Experimental Methodology and Clinical Utility for Anterior Cruciate Ligament Rupture and Associated Injury. Curr Rev Musculoskelet Med. 2019 Mar;12(1):41-49. doi: 10.1007/s12178-019-09529-7.

Reference Type BACKGROUND
PMID: 30706283 (View on PubMed)

Arneja S, Leith J. Review article: Validity of the KT-1000 knee ligament arthrometer. J Orthop Surg (Hong Kong). 2009 Apr;17(1):77-9. doi: 10.1177/230949900901700117.

Reference Type BACKGROUND
PMID: 19398799 (View on PubMed)

Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.

Reference Type BACKGROUND
PMID: 4028566 (View on PubMed)

Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003 May 25;1:17. doi: 10.1186/1477-7525-1-17.

Reference Type BACKGROUND
PMID: 12801417 (View on PubMed)

Kohn MD, Sassoon AA, Fernando ND. Classifications in Brief: Kellgren-Lawrence Classification of Osteoarthritis. Clin Orthop Relat Res. 2016 Aug;474(8):1886-93. doi: 10.1007/s11999-016-4732-4. Epub 2016 Feb 12. No abstract available.

Reference Type BACKGROUND
PMID: 26872913 (View on PubMed)

Pinczewski LA, Lyman J, Salmon LJ, Russell VJ, Roe J, Linklater J. A 10-year comparison of anterior cruciate ligament reconstructions with hamstring tendon and patellar tendon autograft: a controlled, prospective trial. Am J Sports Med. 2007 Apr;35(4):564-74. doi: 10.1177/0363546506296042. Epub 2007 Jan 29.

Reference Type BACKGROUND
PMID: 17261567 (View on PubMed)

Thompson SM, Salmon LJ, Waller A, Linklater J, Roe JP, Pinczewski LA. Twenty-Year Outcome of a Longitudinal Prospective Evaluation of Isolated Endoscopic Anterior Cruciate Ligament Reconstruction With Patellar Tendon or Hamstring Autograft. Am J Sports Med. 2016 Dec;44(12):3083-3094. doi: 10.1177/0363546516658041. Epub 2016 Aug 4.

Reference Type BACKGROUND
PMID: 27492972 (View on PubMed)

Konrads C, Reppenhagen S, Plumhoff P, Hoberg M, Rudert M, Barthel T. No significant difference in clinical outcome and knee stability between patellar tendon and semitendinosus tendon in anterior cruciate ligament reconstruction. Arch Orthop Trauma Surg. 2016 Apr;136(4):521-5. doi: 10.1007/s00402-015-2386-4. Epub 2016 Jan 2.

Reference Type BACKGROUND
PMID: 26725050 (View on PubMed)

Bourke HE, Gordon DJ, Salmon LJ, Waller A, Linklater J, Pinczewski LA. The outcome at 15 years of endoscopic anterior cruciate ligament reconstruction using hamstring tendon autograft for 'isolated' anterior cruciate ligament rupture. J Bone Joint Surg Br. 2012 May;94(5):630-7. doi: 10.1302/0301-620X.94B5.28675.

Reference Type BACKGROUND
PMID: 22529082 (View on PubMed)

Webster KE, Feller JA, Hartnett N, Leigh WB, Richmond AK. Comparison of Patellar Tendon and Hamstring Tendon Anterior Cruciate Ligament Reconstruction: A 15-Year Follow-up of a Randomized Controlled Trial. Am J Sports Med. 2016 Jan;44(1):83-90. doi: 10.1177/0363546515611886. Epub 2015 Nov 17.

Reference Type BACKGROUND
PMID: 26578718 (View on PubMed)

Samuelsen BT, Webster KE, Johnson NR, Hewett TE, Krych AJ. Hamstring Autograft versus Patellar Tendon Autograft for ACL Reconstruction: Is There a Difference in Graft Failure Rate? A Meta-analysis of 47,613 Patients. Clin Orthop Relat Res. 2017 Oct;475(10):2459-2468. doi: 10.1007/s11999-017-5278-9.

Reference Type BACKGROUND
PMID: 28205075 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39221503 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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391796

Identifier Type: -

Identifier Source: org_study_id

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