Initial Graft Tension and ACL Surgery (NCT00434837) | Clinical Trial Compass
CompletedNot Applicable
Initial Graft Tension and ACL Surgery
United States168 participantsStarted 2004-02
Plain-language 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.
Who can participate
Age range
15 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Radiographic Joint Space Narrowing (Midpoint Method)
Timeframe: 3 years
2
Radiographic Joint Space Narrowing (Surface-Fit Method)
Timeframe: 7 years
3
Radiographic Joint Space Narrowing (Kiapour Method)