Initial Graft Tension and ACL Surgery

Not Applicable

Completed

Conditions: Anterior Cruciate Ligament Rupture

Interventions: Procedure: Initial graft tension during ACL reconstruction surgery

Registration Number: NCT00434837

Lead Sponsor: Rhode Island Hospital

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 168

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-tension	Initial graft tension during ACL reconstruction surgery	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.
Low-tension	Initial graft tension during ACL reconstruction surgery	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.

Primary Outcome Measures

Name	Time	Method
Radiographic Joint Space Narrowing (Midpoint Method)	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)	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)	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 Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms	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.
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain	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.
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life	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.
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport	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.
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life	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.
Knee Joint Laxity	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).
Limb Strength International Knee Documentation Committee (IKDC) Score	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.
Short Form-36 (SF-36) Health Survey Physical Functioning	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.
Short Form-36 (SF-36) Health Survey Physical Role	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.
Short Form-36 (SF-36) Health Survey General Health	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.
Short Form-36 (SF-36) Health Survey Bodily Pain	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.
Short Form-36 (SF-36) Health Survey Vitality	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.
Short Form-36 (SF-36) Health Survey Social Function	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.
Short Form-36 (SF-36) Health Survey Emotional Role	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.
Short Form-36 (SF-36) Health Survey Mental Health	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.
Muscle Atrophy	15 years	Thigh circumference 6 cm above the joint line for injured and contralateral knees. Muscle atrophy difference calculated as index-contralateral circumference.
Whole Organ Magnetic Resonance Image Score (WORMS)	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.
One-legged Hop Test	15 years	Ratio of hop distance on the injured knee to the hop distance on the contralateral uninjured knee.
Modified OsteoArthritis Research Society International (OARSI) Score	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.
Isokinetic Strength	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%.
Tegner Activity Scale	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.

Trial Locations

Locations (2): Rhode Island Hospital/Brown University
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Providence, Rhode Island, United States
Miriam Hospital/Brown University
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Providence, Rhode Island, United States