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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00434837 |
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 3-year period.
Condition | Intervention |
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Anterior Cruciate Ligament Rupture |
Procedure: Initial graft tension during ACL reconstruction surgery |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Effects of Initial Graft Tension on Anterior Cruciate Ligament Reconstruction |
Enrollment: | 168 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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.
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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. 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. Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
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2: Experimental
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.
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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. 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. Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
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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 3-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:
Participants will enroll in this 3-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 will occur immediately following surgery and at 6, 12, and 36 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.
Ages Eligible for Study: | 15 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for Groups 1 and 2:
Exclusion Criteria for Groups 1 and 2:
Inclusion Criteria for the Control Group:
Exclusion Criteria for All Participants:
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 |
Principal Investigator: | Braden C. Fleming, PhD | Rhode Island Hospital/Brown Medical School |
Responsible Party: | Rhode Island Hospital ( Braden Fleming/Associate Professor ) |
Study ID Numbers: | R01 AR047910, R01 AR047910 |
Study First Received: | February 9, 2007 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00434837 |
Health Authority: | United States: Federal Government |
Knee Ligament ACL |
Reconstruction Cartilage Osteoarthritis |
Osteoarthritis Rupture |