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Initial Graft Tension and ACL Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00434837
First Posted: February 13, 2007
Last Update Posted: December 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Braden Fleming, Rhode Island Hospital
  Purpose
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 12-year period.

Condition Intervention
Anterior Cruciate Ligament Rupture Procedure: Initial graft tension during ACL reconstruction surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Initial Graft Tension on Anterior Cruciate Ligament Reconstruction

Resource links provided by NLM:


Further study details as provided by Braden Fleming, Rhode Island Hospital:

Primary Outcome Measures:
  • Radiographic joint space narrowing [ Time Frame: 12 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



Secondary Outcome Measures:
  • Knee injury and osteoarthritis outcome score (KOOS) [ Time Frame: 12 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 [ Time Frame: 12 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 [ Time Frame: 12 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 [ Time Frame: 12 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 [ Time Frame: 12 years ]
    Thigh circumference 6 cm above the joint line for injured and contralateral knees

  • Whole Organ Magnetic Resonance Image Score (WORMS) [ Time Frame: 12 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 [ Time Frame: 12 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 [ Time Frame: 12 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 [ Time Frame: 12 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%.


Enrollment: 168
Actual Study Start Date: February 2004
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 12-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 12-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 and 144 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 10 years.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434837


Locations
United States, Rhode Island
Rhode Island Hospital/Brown University
Providence, Rhode Island, United States, 02903
Miriam Hospital/Brown University
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Rhode Island Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Braden C. Fleming, PhD Rhode Island Hospital/Brown Medical School
  Study Documents (Full-Text)

Documents provided by Braden Fleming, Rhode Island Hospital:
  More Information

Publications:

Responsible Party: Braden Fleming, Professor, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00434837     History of Changes
Other Study ID Numbers: R01AR047910 ( U.S. NIH Grant/Contract )
First Submitted: February 9, 2007
First Posted: February 13, 2007
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data are available upon request. Once the study is complete, the data records will be made available through a data repository
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Braden Fleming, Rhode Island Hospital:
Knee
Ligament
ACL
Reconstruction
Cartilage
Osteoarthritis

Additional relevant MeSH terms:
Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries