Initial Graft Tension and ACL Surgery

NCT00434837 | Completed Results DMC

• 2 other identifiers: R01AR047910R01AR074973
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Anterior Cruciate Ligament Rupture

Keywords

Knee; Ligament; ACL; Reconstruction; Cartilage; Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• Radiographic Joint Space Narrowing (Midpoint Method)

  Medial joint space width measurements were obtained from radiographs preoperatively and postoperatively using the semiflexed metatarsophalangeal view. Radiographs were taken of each knee, and the medial compartment joint space width was measured by calculating the distance between the femoral and tibial intersections with the bisecting midpoint line. Analysis was conducted using a MATLAB program. (Mehta N, Duryea J, Badger GJ, et al. Comparison of 2 Radiographic Techniques for Measurement of Tibiofemoral Joint Space Width. Orthop J Sports Med. 2017;5(9):2325967117728675. Published 2017 Sep 26. doi:10.1177/2325967117728675) Subjects are identified as having radiographic signs of OA if they exhibit a change in the medial or lateral compartments greater than 0.30 mm over the study period. This was the first method used for the study. It was used for baseline and 3-year follow-up prior to switching to the 'surface-fit' method at the 7-year follow-up.

  3 years

• Radiographic Joint Space Narrowing (Surface-Fit Method)

  Medial joint space width measurements were obtained from radiographs preoperatively and postoperatively using the semiflexed metatarsophalangeal view. Radiographs were taken of each knee, and the medial compartment joint space width was measured at the midline of the compartment in the coronal plane using a validated computer algorithm. (Duryea et al., Trainable rule-based algorithm for the measurement of joint space width in digital radiographic images of the knee, Medical Physics 27, 580 (2000); doi: 10.1118/1.598897). Subjects are identified as having radiographic signs of OA if they exhibit a change in the medial or lateral compartments greater than 0.30mm over the study period. The surface-fit method was used for the 7-year follow-up and baseline radiographs instead of the Midpoint Method, after confirming less variability across knees within a participant. (Mehta et al. 2017)

  7 years

• Radiographic Joint Space Narrowing (Kiapour Method)

  Joint space width measurements in the medial compartment were calculated from weightbearing radiographs using the semi-flexed metatarsophalangeal view. Radiographs were manually segmented to outline articular surfaces of femur and tibia using Mimics. A custom program in MATLAB developed by Dr. Ata Kiapour was used to calculate joint space width as the perpendicular distance between the femoral condyle and tibial plateau boundaries at 25% of total bicondylar width. Measured JSW values were then scaled using image distances between beads of a calibration standard taped to the fibular head. This method was used for the baseline, 10-12, and 15-year follow-up as a comparable in-house method to the surface-fit method. Subjects are identified as having radiographic signs of OA if they exhibit a change in the medial or lateral compartments greater than 0.30 mm over the study period.

  15 years

Secondary Outcomes (21)

• Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms

  15 years

• Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain

  15 years

• Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life

  15 years

• Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport

  15 years

• Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life

  15 years

Study Arms (3)

Low-tension

EXPERIMENTAL

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.

Procedure: Initial graft tension during ACL reconstruction surgery

High-tension

EXPERIMENTAL

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.

Procedure: Initial graft tension during ACL reconstruction surgery

Uninjured Control Group

NO INTERVENTION

Uninjured age, sex, and race matched control group

Interventions

Initial graft tension during ACL reconstruction surgery PROCEDURE

The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.

High-tension; Low-tension

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Tegner activity score of 5 or greater, indicating participant is at least moderately active
• 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)

Sponsors & Collaborators

• Rhode Island Hospital: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (2)

Rhode Island Hospital/Brown University

Providence, Rhode Island, 02903, United States

Location

Miriam Hospital/Brown University

Providence, Rhode Island, 02906, United States

Location

Related Publications (28)

• Fleming BC, Hulstyn MJ, Oksendahl HL, Fadale PD. Ligament Injury, Reconstruction and Osteoarthritis. Curr Opin Orthop. 2005 Oct;16(5):354-362. doi: 10.1097/01.bco.0000176423.07865.d2.

  PMID: 17710194 BACKGROUND

• 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. doi: 10.1177/0363546506294363. Epub 2007 Jan 11.

  PMID: 17218659 BACKGROUND

• 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. doi: 10.1016/j.joca.2007.09.010. Epub 2007 Oct 22.

  PMID: 17933559 BACKGROUND

• 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. doi: 10.1002/art.23495.

  PMID: 18512776 BACKGROUND

• 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. doi: 10.1016/j.arthro.2008.05.013. Epub 2008 Jun 30.

  PMID: 18760214 BACKGROUND

• 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. doi: 10.1016/j.joca.2008.03.005. Epub 2008 Apr 14.

  PMID: 18407529 BACKGROUND

• 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. doi: 10.1055/s-0030-1247750.

  PMID: 19634723 BACKGROUND

• 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. doi: 10.1016/j.joca.2010.01.009. Epub 2010 Feb 11.

  PMID: 20188685 BACKGROUND

• 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. 2012 Aug;19(4):469-76. doi: 10.1016/j.knee.2011.05.004. Epub 2011 Jun 22.

  PMID: 21696962 BACKGROUND

• Miranda DL, Rainbow MJ, Crisco JJ, Fleming BC. Kinematic differences between optical motion capture and biplanar videoradiography during a jump-cut maneuver. J Biomech. 2013 Feb 1;46(3):567-73. doi: 10.1016/j.jbiomech.2012.09.023. Epub 2012 Oct 22.

  PMID: 23084785 BACKGROUND

• 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. doi: 10.1115/1.4005471.

  PMID: 22206419 BACKGROUND

• 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. doi: 10.1177/0363546510364054. Epub 2010 May 4.

  PMID: 20442327 BACKGROUND

• Coats-Thomas MS, Miranda DL, Badger GJ, Fleming BC. Effects of ACL reconstruction surgery on muscle activity of the lower limb during a jump-cut maneuver in males and females. J Orthop Res. 2013 Dec;31(12):1890-6. doi: 10.1002/jor.22470. Epub 2013 Aug 21.

  PMID: 23966333 BACKGROUND

• Rainbow MJ, Miranda DL, Cheung RT, Schwartz JB, Crisco JJ, Davis IS, Fleming BC. Automatic determination of an anatomical coordinate system for a three-dimensional model of the human patella. J Biomech. 2013 Aug 9;46(12):2093-6. doi: 10.1016/j.jbiomech.2013.05.024. Epub 2013 Jun 20.

  PMID: 23791087 BACKGROUND

• Miranda DL, Fadale PD, Hulstyn MJ, Shalvoy RM, Machan JT, Fleming BC. Knee biomechanics during a jump-cut maneuver: effects of sex and ACL surgery. Med Sci Sports Exerc. 2013 May;45(5):942-51. doi: 10.1249/MSS.0b013e31827bf0e4.

  PMID: 23190595 BACKGROUND

• Zandiyeh P, Parola LR, Fleming BC, Beveridge JE. Wavelet analysis reveals differential lower limb muscle activity patterns long after anterior cruciate ligament reconstruction. J Biomech. 2022 Mar;133:110957. doi: 10.1016/j.jbiomech.2022.110957. Epub 2022 Jan 20.

  PMID: 35114581 BACKGROUND

• Behnke AL, Parola LR, Karamchedu NP, Badger GJ, Fleming BC, Beveridge JE. Neuromuscular function in anterior cruciate ligament reconstructed patients at long-term follow-up. Clin Biomech (Bristol). 2021 Jan;81:105231. doi: 10.1016/j.clinbiomech.2020.105231. Epub 2020 Nov 17.

  PMID: 33246796 BACKGROUND

• Zandiyeh P, Parola LR, Costa MQ, Hague MJ, Molino J, Fleming BC, Beveridge JE. Long-Term Bilateral Neuromuscular Function and Knee Osteoarthritis after Anterior Cruciate Ligament Reconstruction. Bioengineering (Basel). 2023 Jul 6;10(7):812. doi: 10.3390/bioengineering10070812.

  PMID: 37508839 BACKGROUND

• 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. 2013 Jan;41(1):25-34. doi: 10.1177/0363546512464200. Epub 2012 Nov 9.

  PMID: 23144370 RESULT

• Akelman MR, Fadale PD, Hulstyn MJ, Shalvoy RM, Garcia A, Chin KE, Duryea J, Badger GJ, Tung GA, Fleming BC. Effect of Matching or Overconstraining Knee Laxity During Anterior Cruciate Ligament Reconstruction on Knee Osteoarthritis and Clinical Outcomes: A Randomized Controlled Trial With 84-Month Follow-up. Am J Sports Med. 2016 Jul;44(7):1660-70. doi: 10.1177/0363546516638387. Epub 2016 Apr 19.

  PMID: 27159308 RESULT

• Biercevicz AM, Akelman MR, Fadale PD, Hulstyn MJ, Shalvoy RM, Badger GJ, Tung GA, Oksendahl HL, Fleming BC. MRI volume and signal intensity of ACL graft predict clinical, functional, and patient-oriented outcome measures after ACL reconstruction. Am J Sports Med. 2015 Mar;43(3):693-9. doi: 10.1177/0363546514561435. Epub 2014 Dec 24.

  PMID: 25540298 RESULT

• Ware JK, Owens BD, Akelman MR, Karamchedu NP, Fadale PD, Hulstyn MJ, Shalvoy RM, Badger GJ, Fleming BC. Preoperative KOOS and SF-36 Scores Are Associated With the Development of Symptomatic Knee Osteoarthritis at 7 Years After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2018 Mar;46(4):869-875. doi: 10.1177/0363546517751661. Epub 2018 Feb 5.

  PMID: 29401408 RESULT

• DeFroda SF, Karamchedu NP, Owens BD, Bokshan SL, Sullivan K, Fadale PD, Hulstyn MJ, Shalvoy RM, Badger GJ, Fleming BC. Tibial tunnel widening following anterior cruciate ligament reconstruction: A retrospective seven-year study evaluating the effects of initial graft tensioning and graft selection. Knee. 2018 Dec;25(6):1107-1114. doi: 10.1016/j.knee.2018.08.003. Epub 2018 Nov 7.

  PMID: 30414786 RESULT

• Kiapour AM, Yang DS, Badger GJ, Karamchedu NP, Murray MM, Fadale PD, Hulstyn MJ, Shalvoy RM, Fleming BC. Anatomic Features of the Tibial Plateau Predict Outcomes of ACL Reconstruction Within 7 Years After Surgery. Am J Sports Med. 2019 Feb;47(2):303-311. doi: 10.1177/0363546518823556. Epub 2019 Jan 14.

  PMID: 30640519 RESULT

• Fleming BC, Fadale PD, Hulstyn MJ, Shalvoy RM, Tung GA, Badger GJ. Long-term outcomes of anterior cruciate ligament reconstruction surgery: 2020 OREF clinical research award paper. J Orthop Res. 2021 May;39(5):1041-1051. doi: 10.1002/jor.24794. Epub 2020 Jul 17.

  PMID: 32639610 RESULT

• DeFroda SF, Karamchedu NP, Budacki R, Wiley T, Fadale PD, Hulstyn MJ, Shalvoy RM, Badger GJ, Fleming BC, Owens BD. Evaluation of Graft Tensioning Effects in Anterior Cruciate Ligament Reconstruction between Hamstring and Bone-Patellar Tendon Bone Autografts. J Knee Surg. 2021 Jun;34(7):777-783. doi: 10.1055/s-0039-3402046. Epub 2020 Jan 21.

  PMID: 31962350 RESULT

• Costa MQ, Badger GJ, Chrostek CA, Carvalho OD, Faiola SL, Fadale PD, Hulstyn MJ, Gil HC, Shalvoy RM, Fleming BC. Effects of Initial Graft Tension and Patient Sex on Knee Osteoarthritis Outcomes After ACL Reconstruction: A Randomized Controlled Clinical Trial With 10- to 12-Year Follow-up. Am J Sports Med. 2022 Nov;50(13):3510-3521. doi: 10.1177/03635465221124917. Epub 2022 Oct 19.

  PMID: 36259724 RESULT

• Breker AN, Badger GJ, Kiapour AM, Costa MQ, Fleming EN, Ferrara SL, Chrostek CA, Fadale PD, Hulstyn MJ, Shalvoy RM, Gil HC, Fleming BC. Effect of Initial Graft Tension on Knee Osteoarthritis Outcomes After ACL Reconstruction: A Randomized Controlled Clinical Trial With 15-Year Follow-up. Orthop J Sports Med. 2025 Mar 4;13(3):23259671251320972. doi: 10.1177/23259671251320972. eCollection 2025 Mar.

  PMID: 40052176 RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Osteoarthritis

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

The study participant retention rate dropped over time. It should be noted that the method used to determine the Radiographic Joint Space Narrowing outcome measure changed overtime. To account for this, the baseline measure was determined with each method at each timepoint.

Results Point of Contact

• Title: Dr. Braden C. Fleming
• Organization: Rhode Island Hospital

braden_fleming@brown.edu

401-316-4737

Study Officials

• Braden C. Fleming, PhD

  Rhode Island Hospital/Brown Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2007
• First Posted: February 13, 2007
• Study Start: February 1, 2004
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: April 1, 2025
• Results First Posted: December 18, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data are available upon request at any time. There is no end date. Data will also be posted on ClinicalTrials.gov with no end date.
• Access Criteria: Available upon request to the PI. Data on ClinicalTrials.gov are publicly available.

Locations

US (2)