Anterior Cruciate Ligament RuptureNCT00434837

Initial Graft Tension and ACL Surgery

A study testing Initial graft tension during ACL reconstruction surgery in people with Anterior Cruciate Ligament Rupture, run by Rhode Island Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 15 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Anterior Cruciate Ligament Rupture
What is being tested?: Initial graft tension during ACL reconstruction surgery
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 168 participants
Where: 2 sitesUnited States
Study dates: Feb 2004to 29 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 15 to 50 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

ACL injury of only one knee (minor meniscal tears involving less than 1/3 of the meniscus are allowed)
Candidate for ACL reconstruction surgery using a bone-patellar tendon-bone graft or a four-stranded hamstring tendon graft (looped semitendinosus and gracilis muscles)
Tegner activity score of 5 or greater, indicating participant is at least moderately active
Tegner activity score of 5 or greater, indicating participant is at least moderately active

Who cannot join

ACL tear that has occurred more than 12 months prior to surgery
Moderate-sized fissures or lesions in knee articular cartilage
Meniscal tears requiring partial removal of meniscus (tears larger than 1/3 of the meniscus)
Previous injury to either knee
Increased laxity of the medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL), as compared to the uninjured knee
Radiographic evidence of degenerative arthritis
Pregnancy
Any disease that might place a participant at high risk for articular cartilage damage (e.g., rheumatoid arthritis, osteoporosis, metabolic diseases)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Rhode Island Hospital/Brown University
Providence, Rhode Island, 02903
Miriam Hospital/Brown University
Providence, Rhode Island, 02906

Other trials in United States

About this study

Official title: Effects of Initial Graft Tension on Anterior Cruciate Ligament Reconstruction

The anterior cruciate ligament (ACL) is one of four strong ligaments connecting the bones of the knee joint. If overstretched, the ACL can tear. Reconstruction of a torn ACL is now a common surgical procedure. The amount of tension applied to the ACL during reconstruction may indirectly affect the possible onset of arthritis over time. The purpose of this study is to determine the effect of initial graft tension set during ACL reconstruction surgery on the progression of knee arthritis over at least a 15-year period.

Read the detailed description

Damage to the ACL is a common injury that usually requires surgical reconstruction to restore function and prevent progression of post-traumatic osteoarthritis. However, the reconstruction procedure frequently causes degenerative changes to the knee joint over time. The amount of tension applied to the ACL during reconstruction may indirectly affect the possible onset of arthritis over time. High tension would result in less joint motion during the initial healing stages, which may make the onset of arthritis less likely. On the other hand, high tension would result in increased compressive forces between the joint surfaces, which could lead to arthritis. The purpose of this study is to evaluate the effect of initial graft tension set during ACL reconstruction surgery on joint cartilage and the development of knee arthritis over at least a 15-year period.

Participants will include candidates for ACL reconstruction surgery using patellar tendon or hamstring tendon grafts. Participants will be randomly assigned to one of two treatment groups:

Low tension (Group 1) participants will receive low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
High-tension (Group 2) participants will receive high-tension treatment with initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.

Participants will enroll in this 15-year study 1 to 6 weeks prior to ACL surgery. There will be two preoperative study visits: one will include magnetic resonance imaging (MRI) and the other will include a knee evaluation, dynamic function testing, and questionnaires. Postoperative visits occurred immediately following surgery and at 6, 12, 36, 60, 84, 120, 144 and 180 months following surgery. Strength testing, functional testing, x-rays, questionnaires, and a knee exam will occur at most postoperative visits. MRIs will occur at some postoperative visits. An additional group of participants with no evidence of knee injury will serve as a control. The control group will attend all study visits except for the 12-month visit. All participants may be followed for up to 15 years.

Conditions: Anterior Cruciate Ligament Rupture
Being tested: Initial graft tension during ACL reconstruction surgery
Keywords: Knee, Ligament, ACL, Reconstruction, Cartilage, Osteoarthritis
Medical subject headings: Anterior Cruciate Ligament Injuries, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Initial graft tension during ACL reconstruction surgeryProcedure or surgery
The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.

Study groups in NCT00434837
Study group	Role	What they receive
Low-tension	Experimental	Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee. Receives: Procedure: Initial graft tension during ACL reconstruction surgery
High-tension	Experimental	Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee. Receives: Procedure: Initial graft tension during ACL reconstruction surgery
Uninjured Control Group	No intervention	Uninjured age, sex, and race matched control group

What is being measured

The primary outcome is the main question the study is designed to answer.

Radiographic Joint Space Narrowing (Midpoint Method)
Medial joint space width measurements were obtained from radiographs preoperatively and postoperatively using the semiflexed metatarsophalangeal view. Radiographs were taken of each knee, and the medial compartment joint space width was measured by calculating the distance between the femoral and tibial intersections with the bisecting midpoint line. Analysis was conducted using a MATLAB program. (Mehta N, Duryea J, Badger GJ, et al. Comparison of 2 Radiographic Techniques for Measurement of Tibiofemoral Joint Space Width. Orthop J Sports Med. 2017;5(9):2325967117728675. Published 2017 Sep 26. doi:10.1177/2325967117728675) Subjects are identified as having radiographic signs of OA if they exhibit a change in the medial or lateral compartments greater than 0.30 mm over the study period.
This was the first method used for the study. It was used for baseline and 3-year follow-up prior to switching to the 'surface-fit' method at the 7-year follow-up.
Measured: 3 years
Radiographic Joint Space Narrowing (Surface-Fit Method)
Medial joint space width measurements were obtained from radiographs preoperatively and postoperatively using the semiflexed metatarsophalangeal view. Radiographs were taken of each knee, and the medial compartment joint space width was measured at the midline of the compartment in the coronal plane using a validated computer algorithm.
(Duryea et al., Trainable rule-based algorithm for the measurement of joint space width in digital radiographic images of the knee, Medical Physics 27, 580 (2000); doi: 10.1118/1.598897). Subjects are identified as having radiographic signs of OA if they exhibit a change in the medial or lateral compartments greater than 0.30mm over the study period.
The surface-fit method was used for the 7-year follow-up and baseline radiographs instead of the Midpoint Method, after confirming less variability across knees within a participant. (Mehta et al. 2017)
Measured: 7 years
Radiographic Joint Space Narrowing (Kiapour Method)
Joint space width measurements in the medial compartment were calculated from weightbearing radiographs using the semi-flexed metatarsophalangeal view. Radiographs were manually segmented to outline articular surfaces of femur and tibia using Mimics. A custom program in MATLAB developed by Dr. Ata Kiapour was used to calculate joint space width as the perpendicular distance between the femoral condyle and tibial plateau boundaries at 25% of total bicondylar width. Measured JSW values were then scaled using image distances between beads of a calibration standard taped to the fibular head.
This method was used for the baseline, 10-12, and 15-year follow-up as a comparable in-house method to the surface-fit method.
Subjects are identified as having radiographic signs of OA if they exhibit a change in the medial or lateral compartments greater than 0.30 mm over the study period.
Measured: 15 years

Secondary outcomes (21)

Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms
The five dimensions of Knee Osteoarthritis Outcome Score were scored separately: pain , symptoms ,activities of daily life function, sport and recreation function, and knee-related quality of life . Each sub score has a 0-100 scale. 0- extreme knee problems and 100- no knee problems.
Measured: 15 years
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain
The five dimensions of Knee Osteoarthritis Outcome Score were scored separately: pain , symptoms ,activities of daily life function, sport and recreation function, and knee-related quality of life . Each sub score has a 0-100 scale. 0- extreme knee problems and 100- no knee problems.
Measured: 15 years
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life
The five dimensions of Knee Osteoarthritis Outcome Score were scored separately: pain , symptoms ,activities of daily life function, sport and recreation function, and knee-related quality of life . Each sub score has a 0-100 scale. 0- extreme knee problems and 100- no knee problems.
Measured: 15 years
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport
The five dimensions of Knee Osteoarthritis Outcome Score were scored separately: pain , symptoms ,activities of daily life function, sport and recreation function, and knee-related quality of life . Each sub score has a 0-100 scale. 0- extreme knee problems and 100- no knee problems.
Measured: 15 years
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life
The five dimensions of Knee Osteoarthritis Outcome Score were scored separately: pain , symptoms ,activities of daily life function, sport and recreation function, and knee-related quality of life . Each sub score has a 0-100 scale. 0- extreme knee problems and 100- no knee problems.
Measured: 15 years
Knee Joint Laxity
Difference in Anterior-Posterior (A-P) knee laxity value; A-P laxity is defined as the amount of A-P directed translation of the tibia (relative to the femur) between the shear load limits of -90 N (posterior) and 133 N (anterior).
Measured: 15 years
Limb Strength International Knee Documentation Committee (IKDC) Score
Clinical outcome was assessed using the 2000 IKDC Knee Examination Score (http://www.sportsmed.org). The IKDC scores evaluate 4 categories: function, symptoms, range of knee motion, and clinical examination.The IKDC score rates knees as normal (A), nearly normal (B), abnormal (C), and severely abnormal (D), with the final IKDC rating based on the score of the worst category.
Measured: 15 years
Short Form-36 (SF-36) Health Survey Physical Functioning
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
Measured: 15 years
Short Form-36 (SF-36) Health Survey Physical Role
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
Measured: 15 years
Short Form-36 (SF-36) Health Survey General Health
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
Measured: 15 years
Short Form-36 (SF-36) Health Survey Bodily Pain
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
Measured: 15 years
Short Form-36 (SF-36) Health Survey Vitality
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
Measured: 15 years
Short Form-36 (SF-36) Health Survey Social Function
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
Measured: 15 years
Short Form-36 (SF-36) Health Survey Emotional Role
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
Measured: 15 years
Short Form-36 (SF-36) Health Survey Mental Health
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
Measured: 15 years
Muscle Atrophy
Thigh circumference 6 cm above the joint line for injured and contralateral knees. Muscle atrophy difference calculated as index-contralateral circumference.
Measured: 15 years
Whole Organ Magnetic Resonance Image Score (WORMS)
The OA status of the knee was assessed using the semiquantitative Whole Organ Magnetic Resonance Imaging Score (WORMS).The score uses magnetic resonance imaging (MRI) sequences to grade 14 independent features: cartilage signal and morphological characteristics, subarticular bone marrow abnormality, subarticular cysts, subarticular bone attrition, and marginal osteophytes evaluated in 15 regions. The condition of the menisci, cruciate and collateral ligaments, synovitis, loose bodies, and periarticular cysts was also included for a total possible score of 332 points.
0-indicates no damage in anatomical landmarks assessed. 332-severe damage to the anatomical landmarks assessed.
Measured: 15 years
One-legged Hop Test
Ratio of hop distance on the injured knee to the hop distance on the contralateral uninjured knee.
Measured: 15 years
Modified OsteoArthritis Research Society International (OARSI) Score
OARSI-The overall condition of the knee joints of both surgical and contralateral limbs were graded on radiographs by a radiologist. (0-83). 83-severe damage.0- no damage. The difference of the score between surgical and contralateral limbs is also presented.
Measured: 15 years
Isokinetic Strength
Strength of quadriceps muscles was quantified by averaging the peak torques of 3 repetitions and normalizing these values with respect to body weight.Percent torque of surgical compared to contralateral is presented. If the quadriceps muscle of the surgical limb had the same peak torque as the contralateral, it would be 100%.
Measured: 7 years
Tegner Activity Scale
The Tegner activity scale graded activity level based on work and sports activity on a scale of 1-10 with 1 representing physical disability due to knee problems and 10 indicating national or international level soccer participation.
Measured: 15-years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 200429 Feb 2024

First posted13 Feb 2007 (estimated)
Study startFeb 2004
Primary completion29 Feb 2024
Study completion29 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00434837
Sponsor's protocol ID: R01AR047910
Other IDs: R01AR047910, R01AR074973
Status last verified: Aug 2026
First submitted: 9 Feb 2007
Last updated: 25 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data are available upon request. Once the study is completed and published, the data records will be made available through ClinicalTrials.gov

Publications

Fleming BC, Hulstyn MJ, Oksendahl HL, Fadale PD. Ligament Injury, Reconstruction and Osteoarthritis. Curr Opin Orthop. 2005 Oct;16(5):354-362. doi: 10.1097/01.bco.0000176423.07865.d2.
PubMed 17710194
Brady MF, Bradley MP, Fleming BC, Fadale PD, Hulstyn MJ, Banerjee R. Effects of initial graft tension on the tibiofemoral compressive forces and joint position after anterior cruciate ligament reconstruction. Am J Sports Med. 2007 Mar;35(3):395-403. doi: 10.1177/0363546506294363. Epub 2007 Jan 11.
PubMed 17218659
Bowers ME, Tung GA, Trinh N, Leventhal E, Crisco JJ, Kimia B, Fleming BC. Effects of ACL interference screws on articular cartilage volume and thickness measurements with 1.5 T and 3 T MRI. Osteoarthritis Cartilage. 2008 May;16(5):572-8. doi: 10.1016/j.joca.2007.09.010. Epub 2007 Oct 22.
PubMed 17933559
Elsaid KA, Fleming BC, Oksendahl HL, Machan JT, Fadale PD, Hulstyn MJ, Shalvoy R, Jay GD. Decreased lubricin concentrations and markers of joint inflammation in the synovial fluid of patients with anterior cruciate ligament injury. Arthritis Rheum. 2008 Jun;58(6):1707-15. doi: 10.1002/art.23495.
PubMed 18512776
Fleming BC, Brady MF, Bradley MP, Banerjee R, Hulstyn MJ, Fadale PD. Tibiofemoral compression force differences using laxity- and force-based initial graft tensioning techniques in the anterior cruciate ligament-reconstructed cadaveric knee. Arthroscopy. 2008 Sep;24(9):1052-60. doi: 10.1016/j.arthro.2008.05.013. Epub 2008 Jun 30.
PubMed 18760214
Bowers ME, Trinh N, Tung GA, Crisco JJ, Kimia BB, Fleming BC. Quantitative MR imaging using "LiveWire" to measure tibiofemoral articular cartilage thickness. Osteoarthritis Cartilage. 2008 Oct;16(10):1167-73. doi: 10.1016/j.joca.2008.03.005. Epub 2008 Apr 14.
PubMed 18407529
Oksendahl HL, Gomez N, Thomas CS, Badger GD, Hulstyn MJ, Fadale PD, Fleming BC. Digital radiographic assessment of tibiofemoral joint space width: a variance component analysis. J Knee Surg. 2009 Jul;22(3):205-12. doi: 10.1055/s-0030-1247750.
PubMed 19634723
Fleming BC, Oksendahl HL, Mehan WA, Portnoy R, Fadale PD, Hulstyn MJ, Bowers ME, Machan JT, Tung GA. Delayed Gadolinium-Enhanced MR Imaging of Cartilage (dGEMRIC) following ACL injury. Osteoarthritis Cartilage. 2010 May;18(5):662-7. doi: 10.1016/j.joca.2010.01.009. Epub 2010 Feb 11.
PubMed 20188685
Mulcahey MK, Monchik KO, Yongpravat C, Badger GJ, Fadale PD, Hulstyn MJ, Fleming BC. Effects of single-bundle and double-bundle ACL reconstruction on tibiofemoral compressive stresses and joint kinematics during simulated squatting. Knee. 2012 Aug;19(4):469-76. doi: 10.1016/j.knee.2011.05.004. Epub 2011 Jun 22.
PubMed 21696962
Miranda DL, Rainbow MJ, Crisco JJ, Fleming BC. Kinematic differences between optical motion capture and biplanar videoradiography during a jump-cut maneuver. J Biomech. 2013 Feb 1;46(3):567-73. doi: 10.1016/j.jbiomech.2012.09.023. Epub 2012 Oct 22.
PubMed 23084785
Miranda DL, Schwartz JB, Loomis AC, Brainerd EL, Fleming BC, Crisco JJ. Static and dynamic error of a biplanar videoradiography system using marker-based and markerless tracking techniques. J Biomech Eng. 2011 Dec;133(12):121002. doi: 10.1115/1.4005471.
PubMed 22206419
Bowers ME, Tung GA, Oksendahl HL, Hulstyn MJ, Fadale PD, Machan JT, Fleming BC. Quantitative magnetic resonance imaging detects changes in meniscal volume in vivo after partial meniscectomy. Am J Sports Med. 2010 Aug;38(8):1631-7. doi: 10.1177/0363546510364054. Epub 2010 May 4.
PubMed 20442327
Coats-Thomas MS, Miranda DL, Badger GJ, Fleming BC. Effects of ACL reconstruction surgery on muscle activity of the lower limb during a jump-cut maneuver in males and females. J Orthop Res. 2013 Dec;31(12):1890-6. doi: 10.1002/jor.22470. Epub 2013 Aug 21.
PubMed 23966333
Rainbow MJ, Miranda DL, Cheung RT, Schwartz JB, Crisco JJ, Davis IS, Fleming BC. Automatic determination of an anatomical coordinate system for a three-dimensional model of the human patella. J Biomech. 2013 Aug 9;46(12):2093-6. doi: 10.1016/j.jbiomech.2013.05.024. Epub 2013 Jun 20.
PubMed 23791087
Miranda DL, Fadale PD, Hulstyn MJ, Shalvoy RM, Machan JT, Fleming BC. Knee biomechanics during a jump-cut maneuver: effects of sex and ACL surgery. Med Sci Sports Exerc. 2013 May;45(5):942-51. doi: 10.1249/MSS.0b013e31827bf0e4.
PubMed 23190595

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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ACL - Anterior Cruciate Ligament Rupture
Active, not recruiting
Over-the-Top vs. Anteromedial ACLR With Lateral Extraarticular Tenodesis
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Active, not recruiting
Active Noise-Cancelling Headphones With Closed-Loop Communication During Arthroscopic ACL Reconstruction
Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament (ACL) Tear

All Anterior Cruciate Ligament Rupture trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Initial Graft Tension on Anterior Cruciate Ligament Reconstruction
ClinicalTrials.gov ID: NCT00434837
Acronym / sponsor ID: R01AR047910
Conditions: Anterior Cruciate Ligament Rupture
Keywords: Knee, Ligament, ACL, Reconstruction, Cartilage, Osteoarthritis
Study type: Interventional
Recruitment status: Completed
Enrolment: 168 participants (actual)
Lead sponsor: Rhode Island HospitalUniversity, hospital or other
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study start: Feb 2004 (actual)
Primary completion: 29 Feb 2024 (actual)
Study completion: 29 Feb 2024 (actual)
First posted: 13 Feb 2007 (estimated)
Results: Posted 18 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Participants will include candidates for ACL reconstruction surgery using patellar tendon or hamstring tendon grafts. Participants will be randomly assigned to one of two treatment groups:

Low tension (Group 1) participants will receive low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
High-tension (Group 2) participants will receive high-tension treatment with initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Low-tension	Experimental	Procedure: Initial graft tension during ACL reconstruction surgeryPatients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
High-tension	Experimental	Procedure: Initial graft tension during ACL reconstruction surgeryPatients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Uninjured Control Group	No intervention	–Uninjured age, sex, and race matched control group

Who may qualify

Ages: 15 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

ACL injury of only one knee (minor meniscal tears involving less than 1/3 of the meniscus are allowed)
Candidate for ACL reconstruction surgery using a bone-patellar tendon-bone graft or a four-stranded hamstring tendon graft (looped semitendinosus and gracilis muscles)
Tegner activity score of 5 or greater, indicating participant is at least moderately active
Tegner activity score of 5 or greater, indicating participant is at least moderately active

Key exclusion criteria (8 listed)

ACL tear that has occurred more than 12 months prior to surgery
Moderate-sized fissures or lesions in knee articular cartilage
Meniscal tears requiring partial removal of meniscus (tears larger than 1/3 of the meniscus)
Previous injury to either knee
Increased laxity of the medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL), as compared to the uninjured knee

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
Initial graft tension during ACL reconstruction surgeryThe amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.	Procedure or surgery	High-tension, Low-tension

Primary outcome

Radiographic Joint Space Narrowing (Midpoint Method)
Time frame: 3 years
Medial joint space width measurements were obtained from radiographs preoperatively and postoperatively using the semiflexed metatarsophalangeal view. Radiographs were taken of each knee, and the medial compartment joint space width was measured by calculating the distance between the femoral and tibial intersections with the bisecting midpoint line. Analysis was conducted using a MATLAB program. (Mehta N, Duryea J, Badger GJ, et al. Comparison of 2 Radiographic Techniques for Measurement of Tibiofemoral Joint Space Width. Orthop J Sports Med. 2017;5(9):2325967117728675. Published 2017 Sep 26. doi:10.1177/2325967117728675) Subjects are identified as having radiographic signs of OA if they exhibit a change in the medial or lateral compartments greater than 0.30 mm over the study period. This was the first method used for the study. It was used for baseline and 3-year follow-up prior to switching to the 'surface-fit' method at the 7-year follow-up.
Radiographic Joint Space Narrowing (Surface-Fit Method)
Time frame: 7 years
Medial joint space width measurements were obtained from radiographs preoperatively and postoperatively using the semiflexed metatarsophalangeal view. Radiographs were taken of each knee, and the medial compartment joint space width was measured at the midline of the compartment in the coronal plane using a validated computer algorithm. (Duryea et al., Trainable rule-based algorithm for the measurement of joint space width in digital radiographic images of the knee, Medical Physics 27, 580 (2000); doi: 10.1118/1.598897). Subjects are identified as having radiographic signs of OA if they exhibit a change in the medial or lateral compartments greater than 0.30mm over the study period. The surface-fit method was used for the 7-year follow-up and baseline radiographs instead of the Midpoint Method, after confirming less variability across knees within a participant. (Mehta et al. 2017)
Radiographic Joint Space Narrowing (Kiapour Method)
Time frame: 15 years
Joint space width measurements in the medial compartment were calculated from weightbearing radiographs using the semi-flexed metatarsophalangeal view. Radiographs were manually segmented to outline articular surfaces of femur and tibia using Mimics. A custom program in MATLAB developed by Dr. Ata Kiapour was used to calculate joint space width as the perpendicular distance between the femoral condyle and tibial plateau boundaries at 25% of total bicondylar width. Measured JSW values were then scaled using image distances between beads of a calibration standard taped to the fibular head. This method was used for the baseline, 10-12, and 15-year follow-up as a comparable in-house method to the surface-fit method. Subjects are identified as having radiographic signs of OA if they exhibit a change in the medial or lateral compartments greater than 0.30 mm over the study period.

21 secondary outcomes

Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms
Time frame: 15 years
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain
Time frame: 15 years
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life
Time frame: 15 years
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport
Time frame: 15 years
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life
Time frame: 15 years
Knee Joint Laxity
Time frame: 15 years
Limb Strength International Knee Documentation Committee (IKDC) Score
Time frame: 15 years
Short Form-36 (SF-36) Health Survey Physical Functioning
Time frame: 15 years
Short Form-36 (SF-36) Health Survey Physical Role
Time frame: 15 years
Short Form-36 (SF-36) Health Survey General Health
Time frame: 15 years
Short Form-36 (SF-36) Health Survey Bodily Pain
Time frame: 15 years
Short Form-36 (SF-36) Health Survey Vitality
Time frame: 15 years
Short Form-36 (SF-36) Health Survey Social Function
Time frame: 15 years
Short Form-36 (SF-36) Health Survey Emotional Role
Time frame: 15 years
Short Form-36 (SF-36) Health Survey Mental Health
Time frame: 15 years
Muscle Atrophy
Time frame: 15 years
Whole Organ Magnetic Resonance Image Score (WORMS)
Time frame: 15 years
One-legged Hop Test
Time frame: 15 years
Modified OsteoArthritis Research Society International (OARSI) Score
Time frame: 15 years
Isokinetic Strength
Time frame: 7 years
Tegner Activity Scale
Time frame: 15-years

Results and safety

Results posted to the registry on 18 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low-tension	46	26
High-tension	44	21
Uninjured Control Group	60	30

Primary outcome: Radiographic Joint Space Narrowing (Midpoint Method)

Time frame: 3 years. Mean (95% Confidence Interval). Unit: mm

Measure	Low-tension n = 46	High-tension n = 44	Uninjured Control Group n = 60
Baseline	0.0613 (-0.1640 to 0.2870)	0.0634 (-0.1260 to 0.2530)	-0.0321 (-0.1850 to 0.1210)
1-year	0.1374 (-0.0420 to 0.3170)	0.1941 (0.0342 to 0.3540)	-0.2413 (-0.4090 to -0.0740)
3-years	0.0705 (-0.0700 to 0.2110)	0.0192 (-0.1200 to 0.1580)	-0.1321 (-0.3220 to 0.0575)

Low-tension vs High-tension vs Uninjured Control Group: p = .27, ANOVA

Population analysed: Insufficient time for imaging; loss to follow-up.

Primary outcome: Radiographic Joint Space Narrowing (Surface-Fit Method)

Time frame: 7 years. Mean (95% Confidence Interval). Unit: mm

Measure	Low-tension n = 46	High-tension n = 44	Uninjured Control Group n = 60
Baseline	0.1483 (-0.0979 to 0.3944)	0.0029 (-0.2001 to 0.2058)	-0.0492 (-0.2041 to 0.1058)
7-years	0.1858 (-0.0370 to 0.4086)	0.1969 (-0.0855 to 0.4792)	-0.2314 (-0.4259 to -0.0369)

Low-tension vs High-tension vs Uninjured Control Group: p = .08, ANOVA

Population analysed: Insufficient time for imaging; loss to follow-up. Baseline images of subjects presented at 7-year follow-up were analyzed again retroactively with this method.

Primary outcome: Radiographic Joint Space Narrowing (Kiapour Method)

Time frame: 15 years. Mean (95% Confidence Interval). Unit: mm

Measure	Low-tension n = 46	High-tension n = 44	Uninjured Control Group n = 60
Baseline	-0.1076 (-0.3421 to 0.1268)	0.0653 (-0.1947 to 0.3254)	-0.0876 (-0.3242 to 0.1490)
10-12-year	-0.1038 (-0.6593 to 0.4516)	0.3238 (-0.0686 to 0.7162)	0.3269 (-0.1281 to 0.7819)
15-year	0.1136 (-0.5391 to 0.7664)	0.5509 (-0.1457 to 1.2474)	-0.1553 (-0.5961 to 0.2856)

Low-tension vs High-tension vs Uninjured Control Group: p = .22, ANOVA

Population analysed: Insufficient time for imaging; loss to follow-up. Method was used retroactively for existing baseline images.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were self-reported by subjects at each follow-up time-point beginning at 6 months and ending with the 15-year follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low-tension	0 of 46 (0%)	11 of 46 (23.9%)	0 of 46
High-tension	0 of 44 (0%)	20 of 44 (45.5%)	0 of 44
Uninjured Control Group	0 of 60 (0%)	6 of 60 (10%)	0 of 60

Limitations and caveats (from the sponsor): The study participant retention rate dropped over time. It should be noted that the method used to determine the Radiographic Joint Space Narrowing outcome measure changed overtime. To account for this, the baseline measure was determined with each method at each timepoint.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17710194Fleming BC, Hulstyn MJ, Oksendahl HL, Fadale PD. Ligament Injury, Reconstruction and Osteoarthritis. Curr Opin Orthop. 2005 Oct;16(5):354-362. doi: 10.1097/01.bco.0000176423.07865.d2.
Background: PubMed 17218659Brady MF, Bradley MP, Fleming BC, Fadale PD, Hulstyn MJ, Banerjee R. Effects of initial graft tension on the tibiofemoral compressive forces and joint position after anterior cruciate ligament reconstruction. Am J Sports Med. 2007 Mar;35(3):395-403. doi: 10.1177/0363546506294363. Epub 2007 Jan 11.
Background: PubMed 17933559Bowers ME, Tung GA, Trinh N, Leventhal E, Crisco JJ, Kimia B, Fleming BC. Effects of ACL interference screws on articular cartilage volume and thickness measurements with 1.5 T and 3 T MRI. Osteoarthritis Cartilage. 2008 May;16(5):572-8. doi: 10.1016/j.joca.2007.09.010. Epub 2007 Oct 22.
Background: PubMed 18512776Elsaid KA, Fleming BC, Oksendahl HL, Machan JT, Fadale PD, Hulstyn MJ, Shalvoy R, Jay GD. Decreased lubricin concentrations and markers of joint inflammation in the synovial fluid of patients with anterior cruciate ligament injury. Arthritis Rheum. 2008 Jun;58(6):1707-15. doi: 10.1002/art.23495.
Background: PubMed 18760214Fleming BC, Brady MF, Bradley MP, Banerjee R, Hulstyn MJ, Fadale PD. Tibiofemoral compression force differences using laxity- and force-based initial graft tensioning techniques in the anterior cruciate ligament-reconstructed cadaveric knee. Arthroscopy. 2008 Sep;24(9):1052-60. doi: 10.1016/j.arthro.2008.05.013. Epub 2008 Jun 30.
Background: PubMed 18407529Bowers ME, Trinh N, Tung GA, Crisco JJ, Kimia BB, Fleming BC. Quantitative MR imaging using "LiveWire" to measure tibiofemoral articular cartilage thickness. Osteoarthritis Cartilage. 2008 Oct;16(10):1167-73. doi: 10.1016/j.joca.2008.03.005. Epub 2008 Apr 14.
Background: PubMed 19634723Oksendahl HL, Gomez N, Thomas CS, Badger GD, Hulstyn MJ, Fadale PD, Fleming BC. Digital radiographic assessment of tibiofemoral joint space width: a variance component analysis. J Knee Surg. 2009 Jul;22(3):205-12. doi: 10.1055/s-0030-1247750.
Background: PubMed 20188685Fleming BC, Oksendahl HL, Mehan WA, Portnoy R, Fadale PD, Hulstyn MJ, Bowers ME, Machan JT, Tung GA. Delayed Gadolinium-Enhanced MR Imaging of Cartilage (dGEMRIC) following ACL injury. Osteoarthritis Cartilage. 2010 May;18(5):662-7. doi: 10.1016/j.joca.2010.01.009. Epub 2010 Feb 11.
Background: PubMed 21696962Mulcahey MK, Monchik KO, Yongpravat C, Badger GJ, Fadale PD, Hulstyn MJ, Fleming BC. Effects of single-bundle and double-bundle ACL reconstruction on tibiofemoral compressive stresses and joint kinematics during simulated squatting. Knee. 2012 Aug;19(4):469-76. doi: 10.1016/j.knee.2011.05.004. Epub 2011 Jun 22.
Background: PubMed 23084785Miranda DL, Rainbow MJ, Crisco JJ, Fleming BC. Kinematic differences between optical motion capture and biplanar videoradiography during a jump-cut maneuver. J Biomech. 2013 Feb 1;46(3):567-73. doi: 10.1016/j.jbiomech.2012.09.023. Epub 2012 Oct 22.
Background: PubMed 22206419Miranda DL, Schwartz JB, Loomis AC, Brainerd EL, Fleming BC, Crisco JJ. Static and dynamic error of a biplanar videoradiography system using marker-based and markerless tracking techniques. J Biomech Eng. 2011 Dec;133(12):121002. doi: 10.1115/1.4005471.
Background: PubMed 20442327Bowers ME, Tung GA, Oksendahl HL, Hulstyn MJ, Fadale PD, Machan JT, Fleming BC. Quantitative magnetic resonance imaging detects changes in meniscal volume in vivo after partial meniscectomy. Am J Sports Med. 2010 Aug;38(8):1631-7. doi: 10.1177/0363546510364054. Epub 2010 May 4.
Individual participant dataSharing planned: Yes. Data are available upon request. Once the study is completed and published, the data records will be made available through ClinicalTrials.gov

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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.

Braden C. Fleming, PhD principal investigator

Rhode Island Hospital/Brown Medical School

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Initial graft tension during ACL reconstruction surgery in people with Anterior Cruciate Ligament Rupture, run by Rhode Island Hospital at 2 sites in United States.

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 4 inclusion and 8 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 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Yes. Results are posted in the registry (first posted 18 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Radiographic Joint Space Narrowing (Midpoint Method) (time frame: 3 years). The study lists 3 primary outcomes in all. 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 NCT00434837, which also lists 29 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 25 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.