ACLStudie ACLNCT05876013
Reduced Knee Flexion Strength 18 Years After ACL Reconstruction in Hamstring Group Compared to Patellar Tendon Group
An observational study of ACL and ACL Injury, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- ACL, ACL Injury, Cruciate Ligament Rupture
- What is being tested?
- ACL reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 114 participants
- Where
- 1 siteNorway
- Study dates
- 14 Mar 2022to 7 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Norwegian citizens. Patients from Trondelag county operated in Trondheim (StOlav Hospital), patients from Oslo operated at Lovisenberg Diaconal Hospital Oslo, patients from Hordaland operated at Haraldsplass Deaconess Hospital Bergen. Few patients from other counties who wanted operation at spesific hospital were also included if inclusion criteria were met.
Who may be able to join
- 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.
Who cannot join
- ->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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduced Knee Flexion Strength 18 Years After ACL Reconstruction in Hamstring Group
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.
Read more
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.
Read the detailed description
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
- ACL, ACL Injury, Cruciate Ligament Rupture, ACL Tear, Surgery
- Being tested
- ACL reconstruction
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstructionProcedure or surgery
Also called Graft choice,
Randomized between hamstring and patellar tendon graft
| Study group | Role | What they receive |
|---|---|---|
| BPTB group | Bone-patellar tendon- bone graft used for ACL reconstruction. Receives: Procedure: ACL reconstruction | |
| Hamstring group | Double-looped semitendinosus and gracilis graft used for ACL reconstruction Receives: Procedure: ACL reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
KT-1000 arthrometer
KT-1000 test- The KT1000 arthrometer was designed to measure the anterior translation of the tibia while maintaing the femur in position. The results obtained provide an objective diagnostic of the state of the ACL to the medical practitioner.
Measured: Examination day, 1 day.
Secondary outcomes (7)
Gonarthrosis measurement
Kellgren Lawrence classification was used to determine grade of gonarthrosis in operated and non-operated knee, both in patello-femoral and tibio-femoral joint.
Measured: Examination day, 1 day
Biodex isokinetic testing
Biodex is a isokinetic machine used to measure muscle strength and identify weaknesses in certain muscle groups. It can be used in different degrees to measure muscle strength in different positions of the joint.
Measured: Examination day, 1 day.
KOOS score
The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. This direction, 100 indicating no problems, is common in orthopaedic instruments and generic measures like the SF-36.
Measured: Examination day, 1 day
Lysholm's functional score
In the modified Lysholm system the maximum score is 100 points, in which: 91 to 100 points is considered excellent; 84 to 90, good; 65 to 83, fair; and 64 or less, unsatisfactory. Lysholm's system is an evaluation system that includes three functional criteria and five subjective criteria.
Measured: Examination day, 1 day
Tegner's activity score
The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
Measured: Examination day, 1 day.
Pivot shift test
Pivot shift test- positive test is indicated by subluxation of the tibia while the femur rotates externally followed by a reduction of the tibia at 30-40 degrees of flexion.
Measured: Examination day, 1 day.
Lachmann test
Lachmann test- Anterior translation of the tibia associated with a soft or a mushy end-feel indicates a positive test. More than about 2mm of anterior translation compared to the uninvolved knee suggests a torn ACL ("soft end-feel"), as does 10mm of total anterior translation.
Measured: Examination day, 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start14 Mar 2022
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for ACLStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lovisenberg Diakonale Hospital, Haraldsplass Deaconess Hospital
- Responsible party
- Sponsor
- Investigators
- Jon O. Drogset, PhD, Study chair, St Olav Hospital Trondheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876013
- Sponsor's protocol ID
- 391796
- Acronym
- Studie ACL
- Status last verified
- Jun 2025
- First submitted
- 17 Apr 2023
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22869626Leys 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.
PubMed 22184280Freedman 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.
PubMed 12531750Gifstad 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.
PubMed 25201444Gifstad 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.
PubMed 22407182Drogset 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.
PubMed 19956928Herzog 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.
PubMed 30355175Costa-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.
PubMed 31103415Risberg 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.
PubMed 26912282Mohtadi 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.
PubMed 21901700Persson 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.
PubMed 24322979Goldblatt 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.
PubMed 16012491Holm 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.
PubMed 20097928Mascarenhas 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.
PubMed 22048746Sajovic 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.
PubMed 16923826
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Knee Flexion Strength 18 Years After ACL Reconstruction in Hamstring Group
- ClinicalTrials.gov ID
- NCT05876013
- Acronym / sponsor ID
- Studie ACL / 391796
- Conditions
- ACL, ACL Injury, Cruciate Ligament Rupture, ACL Tear, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Lovisenberg Diakonale Hospital, Haraldsplass Deaconess Hospital
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPTB group | – | Procedure: ACL reconstructionBone-patellar tendon- bone graft used for ACL reconstruction. |
| Hamstring group | – | Procedure: ACL reconstructionDouble-looped semitendinosus and gracilis graft used for ACL reconstruction |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Norwegian citizens. Patients from Trondelag county operated in Trondheim (StOlav Hospital), patients from Oslo operated at Lovisenberg Diaconal Hospital Oslo, patients from Hordaland operated at Haraldsplass Deaconess Hospital Bergen. Few patients from other counties who wanted operation at spesific hospital were also included if inclusion criteria were met.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- ->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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL reconstructionAlso: Graft choice,Randomized between hamstring and patellar tendon graft | Procedure or surgery | BPTB group, Hamstring group |
Primary outcome
KT-1000 arthrometer
Time frame: Examination day, 1 day.
KT-1000 test- The KT1000 arthrometer was designed to measure the anterior translation of the tibia while maintaing the femur in position. The results obtained provide an objective diagnostic of the state of the ACL to the medical practitioner.
7 secondary outcomes
Gonarthrosis measurement
Time frame: Examination day, 1 day
Biodex isokinetic testing
Time frame: Examination day, 1 day.
KOOS score
Time frame: Examination day, 1 day
Lysholm's functional score
Time frame: Examination day, 1 day
Tegner's activity score
Time frame: Examination day, 1 day.
Pivot shift test
Time frame: Examination day, 1 day.
Lachmann test
Time frame: Examination day, 1 day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Background: PubMed 22869626Bourke 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.
- Background: PubMed 22184280Leys 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.
- Background: PubMed 12531750Freedman 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.
- Background: PubMed 25201444Gifstad 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.
- Background: PubMed 22407182Gifstad 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.
- Background: PubMed 19956928Drogset 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.
- Background: PubMed 30355175Herzog 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.
- Background: PubMed 31103415Costa-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.
- Background: PubMed 26912282Risberg 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.
- Background: PubMed 21901700Mohtadi 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.
- Background: PubMed 24322979Persson 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.
- Background: PubMed 16012491Goldblatt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon O. Drogset, PhD study chair
St Olav Hospital Trondheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL and ACL Injury, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KT-1000 arthrometer (time frame: Examination day, 1 day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05876013, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.