Initial Graft Tension and ACL Surgery
Key facts
- Who runs it
- Rhode Island Hospital
- Where
- Providence, United StatesSee the 2 sites
- Trial code
- Status
- Completed
- People taking part
- 168 people enrolled
- Started
- Feb 2004
- Ended
- 29 Feb 2024
- Type of study
- Interventional, 3 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Initial graft tension during ACL reconstruction surgery
- Record updated
- 25 August 2026
Who can take part
- Age
- 15 years to 50 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
- Tegner activity score of 5 or greater, indicating participant is at least moderately active
Who cannot take part
- ACL tear that has occurred more than 12 months prior to surgery
- Previous injury to either knee
- Any disease that might place a participant at high risk for articular cartilage damage (e.g., rheumatoid arthritis, osteoporosis, metabolic diseases)
- Moderate-sized fissures or lesions in knee articular cartilage
- Meniscal tears requiring partial removal of meniscus (tears larger than 1/3 of the meniscus)
- 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
Where in United States
- Miriam Hospital/Brown UniversityProvidence, United StatesNo longer taking part
- Rhode Island Hospital, Brown UniversityProvidence, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Low-tensionTreatment being tested
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.
Treatment: Initial graft tension during ACL reconstruction surgery
- High-tensionTreatment being tested
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.
Treatment: Initial graft tension during ACL reconstruction surgery
- Uninjured Control GroupNo study treatment, for comparison
Uninjured age, sex, and race matched control group
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects of Initial Graft Tension on Anterior Cruciate Ligament Reconstruction
- Record updated
- 25 August 2026