Initial Graft Tension and ACL Surgery

• Radiographic joint space narrowing [ Time Frame: 7 years ] [ Designated as safety issue: No ]
• MRI cartilage volume and thickness [ Time Frame: 7 years ] [ Designated as safety issue: No ]
• Knee injury and osteoarthritis outcome score [ Time Frame: 7 years ] [ Designated as safety issue: No ]

• Radiographic joint space narrowing (measured at Year 3)
• MRI cartilage volume and thickness (measured at Year 3)
• knee injury and osteoarthritis outcome score (measured at Year 3)
• whole organ MRI score (measured at Year 3)

• Knee joint laxity [ Time Frame: 7 years ] [ Designated as safety issue: No ]
• Limb strength international knee documentation committee score [ Time Frame: 7 years ] [ Designated as safety issue: No ]
• SF-36 health survey [ Time Frame: Year 3 ] [ Designated as safety issue: No ]
• Muscle atrophy [ Time Frame: 7 years ] [ Designated as safety issue: No ]
• Whole Organ Magnetic Resonance Image Score [ Time Frame: 7 years ] [ Designated as safety issue: No ]

• Knee joint laxity (measured at Year 3)
• limb strength international knee documentation committee score (measured at Year 3)
• SF-36 health survey (measured at Year 3)
• muscle atrophy (measured at Year 3)

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 7-year period.

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 7-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 7-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 will occur immediately following surgery and at 6, 12, 36, 60, and 84 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.

• Experimental: Low-tension
  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.
  Intervention: Procedure: Initial graft tension during ACL reconstruction surgery
• Experimental: High-tension
  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.
  Intervention: Procedure: Initial graft tension during ACL reconstruction surgery

• Fleming BC, Fadale PD, Hulstyn MJ, Shalvoy RM, Oksendahl HL, Badger GJ, Tung GA. The Effect of Initial Graft Tension After Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial With 36-Month Follow-up. Am J Sports Med. 2012 Nov 9. [Epub ahead of print]
• Fleming BC, Hulstyn MJ, Oksendahl HL, Fadale PD. Ligament Injury, Reconstruction and Osteoarthritis. Curr Opin Orthop. 2005 Oct;16(5):354-362.
• Brady MF, Bradley MP, Fleming BC, Fadale PD, Hulstyn MJ, Banerjee R. Effects of initial graft tension on the tibiofemoral compressive forces and joint position after anterior cruciate ligament reconstruction. Am J Sports Med. 2007 Mar;35(3):395-403. Epub 2007 Jan 11.
• Bowers ME, Tung GA, Trinh N, Leventhal E, Crisco JJ, Kimia B, Fleming BC. Effects of ACL interference screws on articular cartilage volume and thickness measurements with 1.5 T and 3 T MRI. Osteoarthritis Cartilage. 2008 May;16(5):572-8. Epub 2007 Oct 22.
• Elsaid KA, Fleming BC, Oksendahl HL, Machan JT, Fadale PD, Hulstyn MJ, Shalvoy R, Jay GD. Decreased lubricin concentrations and markers of joint inflammation in the synovial fluid of patients with anterior cruciate ligament injury. Arthritis Rheum. 2008 Jun;58(6):1707-15.
• Fleming BC, Brady MF, Bradley MP, Banerjee R, Hulstyn MJ, Fadale PD. Tibiofemoral compression force differences using laxity- and force-based initial graft tensioning techniques in the anterior cruciate ligament-reconstructed cadaveric knee. Arthroscopy. 2008 Sep;24(9):1052-60. Epub 2008 Jun 30.
• Bowers ME, Trinh N, Tung GA, Crisco JJ, Kimia BB, Fleming BC. Quantitative MR imaging using "LiveWire" to measure tibiofemoral articular cartilage thickness. Osteoarthritis Cartilage. 2008 Oct;16(10):1167-73. Epub 2008 Apr 14.
• Oksendahl HL, Gomez N, Thomas CS, Badger GD, Hulstyn MJ, Fadale PD, Fleming BC. Digital radiographic assessment of tibiofemoral joint space width: a variance component analysis. J Knee Surg. 2009 Jul;22(3):205-12.
• Fleming BC, Oksendahl HL, Mehan WA, Portnoy R, Fadale PD, Hulstyn MJ, Bowers ME, Machan JT, Tung GA. Delayed Gadolinium-Enhanced MR Imaging of Cartilage (dGEMRIC) following ACL injury. Osteoarthritis Cartilage. 2010 May;18(5):662-7. Epub 2010 Feb 11.
• Mulcahey MK, Monchik KO, Yongpravat C, Badger GJ, Fadale PD, Hulstyn MJ, Fleming BC. Effects of single-bundle and double-bundle ACL reconstruction on tibiofemoral compressive stresses and joint kinematics during simulated squatting. Knee. 2011 Jun 20; [Epub ahead of print]
• Miranda DL, Rainbow MJ, Crisco JJ, Fleming BC. Kinematic differences between optical motion capture and biplanar videoradiography during a jump-cut maneuver. J Biomech. 2012 Oct 18. doi:pii: S0021-9290(12)00568-4. 10.1016/j.jbiomech.2012.09.023. [Epub ahead of print]
• Miranda DL, Schwartz JB, Loomis AC, Brainerd EL, Fleming BC, Crisco JJ. Static and dynamic error of a biplanar videoradiography system using marker-based and markerless tracking techniques. J Biomech Eng. 2011 Dec;133(12):121002.
• Bowers ME, Tung GA, Oksendahl HL, Hulstyn MJ, Fadale PD, Machan JT, Fleming BC. Quantitative magnetic resonance imaging detects changes in meniscal volume in vivo after partial meniscectomy. Am J Sports Med. 2010 Aug;38(8):1631-7. Epub 2010 May 4.

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)