Overview

This trial is active, not recruiting.

Condition anterior cruciate ligament rupture
Treatment initial graft tension during acl reconstruction surgery
Sponsor Rhode Island Hospital
Collaborator National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Start date February 2004
End date May 2020
Trial size 168 participants
Trial identifier NCT00434837, R01 AR047910, R01AR047910

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 12-year period.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
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.
(Experimental)
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.
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.

Primary Outcomes

Measure
Radiographic joint space narrowing
time frame: 12 years
MRI cartilage volume and thickness
time frame: 12 years
Knee injury and osteoarthritis outcome score
time frame: 12 years

Secondary Outcomes

Measure
Knee joint laxity
time frame: 12 years
Limb strength international knee documentation committee score
time frame: 12 years
SF-36 health survey
time frame: 12 years
Muscle atrophy
time frame: 12 years
Whole Organ Magnetic Resonance Image Score
time frame: 12 years

Eligibility Criteria

Male or female participants from 15 years up to 50 years old.

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)

Additional Information

Official title Effects of Initial Graft Tension on Anterior Cruciate Ligament Reconstruction
Principal investigator Braden C. Fleming, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Rhode Island Hospital.