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NCT Number: NCT00434837

Initial Graft Tension and ACL Surgery

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.

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Key information

Conditions

Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injuries Arthritis Joint Diseases Knee Injuries Leg Injuries Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Wounds and Injuries

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miriam Hospital/Brown University, Providence, Rhode Island, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Groups 1 and 2:

  • 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

Exclusion criteria

for Groups 1 and 2:

  • 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)

Inclusion criteria

for the Control Group:

  • Tegner activity score of 5 or greater, indicating participant is at least moderately active

Exclusion criteria

for All Participants:

  • 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)

Treatment and study plan

Initial graft tension during ACL reconstruction surgery

Procedure

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.

Primary outcomes

  1. 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.

  2. 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)

  3. 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.

Secondary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms

    Time frame: 15 years

    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.

  2. Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain

    Time frame: 15 years

    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.

  3. Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life

    Time frame: 15 years

    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.

  4. Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport

    Time frame: 15 years

    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.

  5. Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life

    Time frame: 15 years

    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.

  6. Knee Joint Laxity

    Time frame: 15 years

    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).

  7. Limb Strength International Knee Documentation Committee (IKDC) Score

    Time frame: 15 years

    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.

  8. Short Form-36 (SF-36) Health Survey Physical Functioning

    Time frame: 15 years

    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.

  9. Short Form-36 (SF-36) Health Survey Physical Role

    Time frame: 15 years

    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.

  10. Short Form-36 (SF-36) Health Survey General Health

    Time frame: 15 years

    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.

  11. Short Form-36 (SF-36) Health Survey Bodily Pain

    Time frame: 15 years

    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.

  12. Short Form-36 (SF-36) Health Survey Vitality

    Time frame: 15 years

    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.

  13. Short Form-36 (SF-36) Health Survey Social Function

    Time frame: 15 years

    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.

  14. Short Form-36 (SF-36) Health Survey Emotional Role

    Time frame: 15 years

    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.

  15. Short Form-36 (SF-36) Health Survey Mental Health

    Time frame: 15 years

    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.

  16. Muscle Atrophy

    Time frame: 15 years

    Thigh circumference 6 cm above the joint line for injured and contralateral knees. Muscle atrophy difference calculated as index-contralateral circumference.

  17. Whole Organ Magnetic Resonance Image Score (WORMS)

    Time frame: 15 years

    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.

  18. One-legged Hop Test

    Time frame: 15 years

    Ratio of hop distance on the injured knee to the hop distance on the contralateral uninjured knee.

  19. Modified OsteoArthritis Research Society International (OARSI) Score

    Time frame: 15 years

    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.

  20. Isokinetic Strength

    Time frame: 7 years

    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%.

  21. Tegner Activity Scale

    Time frame: 15-years

    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.

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Effects of Initial Graft Tension on Anterior Cruciate Ligament Reconstruction

Important dates

Study start
2004
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2007
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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