Initial Graft Tension and ACL Surgery

April 11, 2024 updated by: Braden Fleming, Rhode Island Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital/Brown University
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital/Brown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-tension
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.
Procedure: Initial graft tension during ACL reconstruction 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.
Experimental: High-tension
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.
Procedure: Initial graft tension during ACL reconstruction 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.
No Intervention: Uninjured Control Group
Uninjured age, sex, and race matched control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic joint space narrowing
Time Frame: 15 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 that 0.30mm over the study period
15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee injury and osteoarthritis outcome score (KOOS)
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.
15 years
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).
15 years
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.
15 years
Short Form-36 (SF-36) health survey
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 years
Muscle atrophy
Time Frame: 15 years
Thigh circumference 6 cm above the joint line for injured and contralateral knees
15 years
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.
15 years
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.
15 years
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.
15 years
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%.
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Collaborators

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

Investigators

  • Principal Investigator: Braden C. Fleming, PhD, Rhode Island Hospital/Brown Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2004

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

February 9, 2007

First Submitted That Met QC Criteria

February 9, 2007

First Posted (Estimated)

February 13, 2007

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AR047910 (U.S. NIH Grant/Contract)
  • R01AR074973 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data are available upon request. Once the study is complete, the data records will be made available through a data repository

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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