Status:
COMPLETED
Initial Graft Tension and ACL Surgery
Lead Sponsor:
Rhode Island Hospital
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Anterior Cruciate Ligament Rupture
Eligibility:
All Genders
15-50 years
Phase:
NA
Brief 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 p...
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 f...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2024
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00434837
Start Date
February 1 2004
End Date
February 29 2024
Last Update
April 1 2025
Active Locations (2)
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1
Rhode Island Hospital/Brown University
Providence, Rhode Island, United States, 02903
2
Miriam Hospital/Brown University
Providence, Rhode Island, United States, 02906