N/A
N=150
Initial Graft Tension and ACL Surgery
Anterior Cruciate Ligament Rupture
Bottom Line
View on ClinicalTrials.gov: NCT00434837 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Radiographic Joint Space Narrowing (Midpoint Method) — 0.0613; 0.0634; -0.0321; 0.1374 mm — p=.27
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Initial graft tension during ACL reconstruction surgery (Procedure)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Rhode Island Hospital
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiographic Joint Space Narrowing (Midpoint Method) |
0.0613; 0.0634; -0.0321; 0.1374; 0.1941; -0.2413 | .27 |
| PRIMARY Radiographic Joint Space Narrowing (Surface-Fit Method) |
0.1483; 0.0029; -0.0492; 0.1858; 0.1969; -0.2314 | .08 |
| PRIMARY Radiographic Joint Space Narrowing (Kiapour Method) |
-0.1076; 0.0653; -0.0876; -0.1038; 0.3238; 0.3269 | .22 |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms |
70.3704; 70.4319; 96.7292; 79.5168; 78.4184; 84.1270 | .0078 sig |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain |
75.3549; 77.0187; 98.8889; 86.6422; 86.2302; 90.2317 | .0018 sig |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life |
85.7680; 84.3365; 99.9755; 94.8097; 90.5462; 94.5440 | .015 sig |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport |
54.7866; 54.8882; 98.0720; 75.7059; 73.9286; 79.5708 | .003 sig |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life |
35.6944; 37.9360; 97.3517; 61.2132; 58.1250; 74.0612 | .0006 sig |
| SECONDARY Knee Joint Laxity |
4.5107; 4.1532; 0.4383; 1.6605; 0.8389; 2.3026 | .15 |
| SECONDARY Limb Strength International Knee Documentation Committee (IKDC) Score |
0; 0; 58; 27; 28; 2 | .34 |
| SECONDARY Short Form-36 (SF-36) Health Survey Physical Functioning |
70.0000; 70.1163; 98.3333; 83.8971; 83.1429; 89.1667 | .17 |
| SECONDARY Short Form-36 (SF-36) Health Survey Physical Role |
59.5833; 54.0698; 97.6389; 86.3971; 82.5840; 91.8403 | .25 |
| SECONDARY Short Form-36 (SF-36) Health Survey General Health |
81.9111; 84.9767; 86.1667; 83.4412; 82.2286; 84.9722 | .61 |
| SECONDARY Short Form-36 (SF-36) Health Survey Bodily Pain |
62.3778; 61.0000; 86.6500; 80.2727; 77.5571; 82.4167 | .15 |
| SECONDARY Short Form-36 (SF-36) Health Survey Vitality |
62.6733; 64.0988; 73.2292; 65.3409; 73.3929; 69.7917 | .53 |
| SECONDARY Short Form-36 (SF-36) Health Survey Social Function |
81.1111; 75.5814; 96.4583; 88.6364; 90.0000; 92.7083 | .82 |
| SECONDARY Short Form-36 (SF-36) Health Survey Emotional Role |
85.3704; 85.3175; 96.6667; 89.3930; 91.9188; 92.1278 | .03 sig |
| SECONDARY Short Form-36 (SF-36) Health Survey Mental Health |
74.1111; 74.8837; 84.1667; 80.0000; 83.5714; 78.4722 | .67 |
| SECONDARY Muscle Atrophy |
-0.0267; -0.2093; 0.0293; 0.9324; 0.7071; 0.6579 | — |
| SECONDARY Whole Organ Magnetic Resonance Image Score (WORMS) |
3.7941; 6.1875; 0.9167; 3.5278; 6.9286; -0.9583 | .051 |
| SECONDARY One-legged Hop Test |
76.8510; 76.9565; 101.0724; 91.2106; 93.0460; 100.6628 | .14 |
| SECONDARY Modified OsteoArthritis Research Society International (OARSI) Score |
-0.0541; -0.1081; -0.2604; 0; 0.3400; -0.3125 | .067 |
| SECONDARY Isokinetic Strength |
80.0994; 74.6156; 101.8830; 86.6887; 82.6245; 105.7979 | .54 |
| SECONDARY Tegner Activity Scale |
7.6087; 7.6363; 6.5333; 6.1282; 6.6000; 6.3111 | .08 |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00434837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.