Clinical trial NCT05532189: Anterior Cruciate Ligament (ACL) Reconstruction with Bone Tendon Bone Autograft with Versus Without Internal Bracing
Official title: ACL Reconstruction with Bone Tendon Bone (BTB) Autograft with Versus Without Internal Brace - Clinical and Radiographic Outcomes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ACL Tear
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to the ACL reconstruction without internal bracing group (control) or to the ACL reconstruction with internal bracing (experimental).
Primary purpose: TREATMENT

Brief summary: There is no consensus regarding the best surgical management of primary ACL tears. Recent evidence suggests that internal brace augmentation may increase load failure and therefore stabilize the graft in-situ at the time of ACL reconstruction. This prospective randomized controlled trial aims to compare the time to return to activity, and participant reported outcomes in participants with bone-tendon-bone ACL reconstruction with and without (control) internal brace augmentation.

Detailed description: Despite the wide variety of surgical approaches and grafts that can be used in an ACL reconstruction, graft failure and recurrent knee instability are nevertheless ubiquitous issues that have facilitated interest in ways to strengthen the graft at the time of surgery. While both animal and biomechanical models have strongly suggested improved graft strength and patient outcomes by utilizing suture tape augmentation in ACL reconstructions, there is scant clinical literature available to assess these extrapolations. A retrospective cohort study of 60 patients undergoing ACL reconstruction with a hamstring autograft or allograft (30 suture tape vs 30 no suture tape; mean age: 30), found shorter time to return to activity (9.2 months suture tape group vs 12.9 months no suture tape group; p=0.002), lower Western Ontario and McMaster University Osteoarthritis Indices (WOMAC) (2.2 suture tape group vs 6.2 no suture tape group; p=0.024), higher international knee documentation committee (IKDC) scores (87.6 suture tape group vs 73.2 no suture tape group; p=0.006), lower average pain on the national pain rating scale (NPRS) (0.6 suture tape group vs 1.66 no suture tape group; p=0.021) and no significant difference in range of motion in degrees (129 suture tape group vs 127 no suture tape group; p=0.46), knee injury and osteoarthritis outcome score (KOOS) (92.2 suture tape group vs 87.1 no suture tape group; p=0.68), or complications (13% suture tape vs 10% no suture tape; p\>0.05) at 2 years follow up. A retrospective cohort study of 108 patients undergoing ACL reconstruction with a hamstring autograft with and without suture tape reinforcement (36 suture tape vs 72 no suture tape; mean age: 25), found a significantly higher Tegner activity score (7.1 suture tape group vs 6.4 no suture tape group; p=0.026) but otherwise no significant difference in time to preinjury activity level (11.9 mos suture tape group vs 11.6 no suture tape group; p=0.59), range of motion (degrees) (136 suture tape group vs 137 no suture tape group; p=0.44) , Lysholm knee score (95.6 suture tape group vs 94 no suture tape group; p=0.165), IKDC score (94.4 suture tape group vs 93.8 no suture tape group; p=0.44), or complications (6% suture tape group vs 5% no suture tape group; p\>0.05) at 2 years follow up. A prospective cohort study of 50 ACL reconstructions with hamstring autograft with and without suture tape reinforcement (25 suture tape group vs 25 no suture tape group; mean age: 30), found a significant improvement in greater than 2 grades of Lachman testing from preoperative assessment compared to 6 months follow-up (68% suture tape group vs 32% no suture tape group; p=0.039) but no difference in Lysholm knee score at 6 months (87.0 suture tape group vs 87.0 no suture tape group; p=0.756). Moreover, none of the already-limited clinical data investigates the use of internal braces with bone-tendon-bone grafts, which are a popular choice for young adults and athletes. Furthermore, there are no current level 1 data on this subject. Therefore, this study aims to compare the time to return to pre- injury activity level, incidence of recurrent knee instability, and patient reported outcomes of patients treated with ACL reconstruction using bone-tendon-bone autograft with and without (control group) internal brace stabilization.

Eligibility criteria: Inclusion Criteria:

* patients 12 and older
* patients seen by the Columbia University Sports Medicine Service
* patients diagnosed with a first time ACL injury by clinical exam and MRI

Exclusion Criteria:

* previous knee surgery
* concurrent knee fracture or ligamentous injury on ipsilateral knee
* neuromuscular disorder involving lower limb
* inability/ unwillingness to adhere to protocol
* anesthesia contraindications
* lost to follow up

Primary outcomes:
measure: Time to Return to Full Activity or Sports
timeFrame: Measured once per participant, depending on the time required to return to full activity (up to 10 years)
measure: Percentage of Participants with Recurrent Knee Instability
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
measure: Change in Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Test (CAT) at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in PROMIS PF CAT at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in PROMIS PF CAT at 3 months
timeFrame: Baseline and 3 months
measure: Change in PROMIS PF CAT at 6 months
timeFrame: Baseline and 6 months
measure: Change in PROMIS PF CAT at 1 year
timeFrame: Baseline and 1 year
measure: Change in PROMIS PF CAT at 2 years
timeFrame: Baseline and 2 years
measure: Change in PROMIS PF CAT at 5 years
timeFrame: Baseline and 5 years
measure: Change in PROMIS PF CAT at 10 years
timeFrame: Baseline and 10 years
measure: Change in PROMIS Pain Interference (PI) CAT at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in PROMIS PI CAT at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in PROMIS PI CAT at 3 months
timeFrame: Baseline and 3 months
measure: Change in PROMIS PI CAT at 6 months
timeFrame: Baseline and 6 months
measure: Change in PROMIS PI CAT at 1 year
timeFrame: Baseline and 1 year
measure: Change in PROMIS PI CAT at 2 years
timeFrame: Baseline and 2 years
measure: Change in PROMIS PI CAT at 5 years
timeFrame: Baseline and 5 years
measure: Change in PROMIS PI CAT at 10 years
timeFrame: Baseline and 10 years
measure: Change in PROMIS Depression CAT at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in PROMIS Depression CAT at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in PROMIS Depression CAT at 3 months
timeFrame: Baseline and 3 months
measure: Change in PROMIS Depression CAT at 6 months
timeFrame: Baseline and 6 months
measure: Change in PROMIS Depression CAT at 1 year
timeFrame: Baseline and 1 year
measure: Change in PROMIS Depression CAT at 2 years
timeFrame: Baseline and 2 years
measure: Change in PROMIS Depression CAT at 5 years
timeFrame: Baseline and 5 years
measure: Change in PROMIS Depression CAT at 10 years
timeFrame: Baseline and 10 years
Secondary outcomes:
measure: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 3 months
timeFrame: Baseline and 3 months
measure: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 months
timeFrame: Baseline and 6 months
measure: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 1 year
timeFrame: Baseline and 1 year
measure: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 years
timeFrame: Baseline and 2 years
measure: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 5 years
timeFrame: Baseline and 5 years
measure: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 10 years
timeFrame: Baseline and 10 years
measure: Change in International Knee Documentation Committee (IKDC) Score at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in International Knee Documentation Committee (IKDC) Score at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in International Knee Documentation Committee (IKDC) Score at 3 months
timeFrame: Baseline and 3 months
measure: Change in International Knee Documentation Committee (IKDC) Score at 6 months
timeFrame: Baseline and 6 months
measure: Change in International Knee Documentation Committee (IKDC) Score at 1 year
timeFrame: Baseline and 1 year
measure: Change in International Knee Documentation Committee (IKDC) Score at 2 years
timeFrame: Baseline and 2 years
measure: Change in International Knee Documentation Committee (IKDC) Score at 5 years
timeFrame: Baseline and 5 years
measure: Change in International Knee Documentation Committee (IKDC) Score at 10 years
timeFrame: Baseline and 10 years
measure: Change in numeric pain rating scale (NPRS) Score at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in numeric pain rating scale (NPRS) Score at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in numeric pain rating scale (NPRS) Score at 3 months
timeFrame: Baseline and 3 months
measure: Change in numeric pain rating scale (NPRS) Score at 6 months
timeFrame: Baseline and 6 months
measure: Change in numeric pain rating scale (NPRS) Score at 1 year
timeFrame: Baseline and 1 year
measure: Change in numeric pain rating scale (NPRS) Score at 2 years
timeFrame: Baseline and 2 years
measure: Change in numeric pain rating scale (NPRS) Score at 5 years
timeFrame: Baseline and 5 years
measure: Change in numeric pain rating scale (NPRS) Score at 10 years
timeFrame: Baseline and 10 years
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months
timeFrame: Baseline and 3 months
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 months
timeFrame: Baseline and 6 months
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1 year
timeFrame: Baseline and 1 year
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 years
timeFrame: Baseline and 2 years
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 5 years
timeFrame: Baseline and 5 years
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 10 years
timeFrame: Baseline and 10 years
measure: Change in Tegner activity scale (TAS) Score at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in Tegner activity scale (TAS) Score at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in Tegner activity scale (TAS) Score at 3 months
timeFrame: Baseline and 3 months
measure: Change in Tegner activity scale (TAS) Score at 6 months
timeFrame: Baseline and 6 months
measure: Change in Tegner activity scale (TAS) Score at 1 year
timeFrame: Baseline and 1 year
measure: Change in Tegner activity scale (TAS) Score at 2 years
timeFrame: Baseline and 2 years
measure: Change in Tegner activity scale (TAS) Score at 5 years
timeFrame: Baseline and 5 years
measure: Change in Tegner activity scale (TAS) Score at 10 years
timeFrame: Baseline and 10 years
measure: Change in Lysholm Score at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in Lysholm Score at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in Lysholm Score at 3 months
timeFrame: Baseline and 3 months
measure: Change in Lysholm Score at 6 months
timeFrame: Baseline and 6 months
measure: Change in Lysholm Score at 1 year
timeFrame: Baseline and 1 year
measure: Change in Lysholm Score at 2 years
timeFrame: Baseline and 2 years
measure: Change in Lysholm Score at 5 years
timeFrame: Baseline and 5 years
measure: Change in Lysholm Score at 10 years
timeFrame: Baseline and 10 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Assistant Professor of Orthopedic Surgery
name: David Trofa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mall NA, Chalmers PN, Moric M, Tanaka MJ, Cole BJ, Bach BR Jr, Paletta GA Jr. Incidence and trends of anterior cruciate ligament reconstruction in the United States. Am J Sports Med. 2014 Oct;42(10):2363-70. doi: 10.1177/0363546514542796. Epub 2014 Aug 1.
citation: Cohen SB, Yucha DT, Ciccotti MC, Goldstein DT, Ciccotti MA, Ciccotti MG. Factors affecting patient selection of graft type in anterior cruciate ligament reconstruction. Arthroscopy. 2009 Sep;25(9):1006-10. doi: 10.1016/j.arthro.2009.02.010.
citation: Spindler KP, Wright RW. Clinical practice. Anterior cruciate ligament tear. N Engl J Med. 2008 Nov 13;359(20):2135-42. doi: 10.1056/NEJMcp0804745. No abstract available.
citation: Engebretsen L, Benum P, Fasting O, Molster A, Strand T. A prospective, randomized study of three surgical techniques for treatment of acute ruptures of the anterior cruciate ligament. Am J Sports Med. 1990 Nov-Dec;18(6):585-90. doi: 10.1177/036354659001800605.
citation: Bowman EN, Limpisvasti O, Cole BJ, ElAttrache NS. Anterior Cruciate Ligament Reconstruction Graft Preference Most Dependent on Patient Age: A Survey of United States Surgeons. Arthroscopy. 2021 May;37(5):1559-1566. doi: 10.1016/j.arthro.2021.01.042. Epub 2021 Feb 1.
citation: Bodendorfer BM, Michaelson EM, Shu HT, Apseloff NA, Spratt JD, Nolton EC, Argintar EH. Suture Augmented Versus Standard Anterior Cruciate Ligament Reconstruction: A Matched Comparative Analysis. Arthroscopy. 2019 Jul;35(7):2114-2122. doi: 10.1016/j.arthro.2019.01.054. Epub 2019 Jun 2.
citation: Parkes CW, Leland DP, Levy BA, Stuart MJ, Camp CL, Saris DBF, Krych AJ. Hamstring Autograft Anterior Cruciate Ligament Reconstruction Using an All-Inside Technique With and Without Independent Suture Tape Reinforcement. Arthroscopy. 2021 Feb;37(2):609-616. doi: 10.1016/j.arthro.2020.09.002. Epub 2020 Nov 2.
citation: Batty LM, Norsworthy CJ, Lash NJ, Wasiak J, Richmond AK, Feller JA. Synthetic devices for reconstructive surgery of the cruciate ligaments: a systematic review. Arthroscopy. 2015 May;31(5):957-68. doi: 10.1016/j.arthro.2014.11.032. Epub 2015 Jan 22.
citation: Smith PA, Bley JA. Allograft Anterior Cruciate Ligament Reconstruction Utilizing Internal Brace Augmentation. Arthrosc Tech. 2016 Oct 10;5(5):e1143-e1147. doi: 10.1016/j.eats.2016.06.007. eCollection 2016 Oct.
citation: E A Mackenzie C, Huntington LS, Tulloch S. Suture Tape Augmentation of Anterior Cruciate Ligament Reconstruction Increases Biomechanical Stability: A Scoping Review of Biomechanical, Animal, and Clinical Studies. Arthroscopy. 2022 Jun;38(6):2073-2089. doi: 10.1016/j.arthro.2021.12.036. Epub 2022 Jan 3.