Anterior Cruciate Ligament (ACL) Reconstruction With Bone Tendon Bone Autograft With Versus Without Internal Bracing

NCT05532189 | Not Yet Recruiting

• 1 other identifier: AAAU0966
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL Tear

Outcome Measures

Primary Outcomes (26)

• Time to Return to Full Activity or Sports

  Time from treatment initiation to full return to pre-injury activity levels in each group, expressed in weeks

  Measured once per participant, depending on the time required to return to full activity (up to 10 years)

• Percentage of Participants with Recurrent Knee Instability

  Percentage of participants that experience recurrent instability after treatment starts at each time point

  2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years

• Change in Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Test (CAT) at 2 weeks

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 2 weeks

• Change in PROMIS PF CAT at 6 weeks

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 6 weeks

• Change in PROMIS PF CAT at 3 months

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 3 months

• Change in PROMIS PF CAT at 6 months

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 6 months

• Change in PROMIS PF CAT at 1 year

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 1 year

• Change in PROMIS PF CAT at 2 years

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 2 years

• Change in PROMIS PF CAT at 5 years

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 5 years

• Change in PROMIS PF CAT at 10 years

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 10 years

• Change in PROMIS Pain Interference (PI) CAT at 2 weeks

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 2 weeks

• Change in PROMIS PI CAT at 6 weeks

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 6 weeks

• Change in PROMIS PI CAT at 3 months

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 3 months

• Change in PROMIS PI CAT at 6 months

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 6 months

• Change in PROMIS PI CAT at 1 year

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 1 year

• Change in PROMIS PI CAT at 2 years

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 2 years

• Change in PROMIS PI CAT at 5 years

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 5 years

• Change in PROMIS PI CAT at 10 years

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 10 years

• Change in PROMIS Depression CAT at 2 weeks

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 2 weeks

• Change in PROMIS Depression CAT at 6 weeks

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 6 weeks

• Change in PROMIS Depression CAT at 3 months

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 3 months

• Change in PROMIS Depression CAT at 6 months

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 6 months

• Change in PROMIS Depression CAT at 1 year

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 1 year

• Change in PROMIS Depression CAT at 2 years

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 2 years

• Change in PROMIS Depression CAT at 5 years

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 5 years

• Change in PROMIS Depression CAT at 10 years

  A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.

  Baseline and 10 years

Secondary Outcomes (48)

• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 weeks

  Baseline and 2 weeks

• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 weeks

  Baseline and 6 weeks

• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 3 months

  Baseline and 3 months

• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 months

  Baseline and 6 months

• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 1 year

  Baseline and 1 year

Study Arms (2)

ACL reconstruction with internal brace augmentation (suture tape)

EXPERIMENTAL

This group will receive a standard ACL reconstruction using a BTB autograft with suture tape augmentation on the graft to strengthen it during the surgical procedure.

Procedure: ACL reconstruction with BTB autograft with internal brace augmentation (suture tape); Other: Standardized Rehabilitation Protocol

ACL reconstruction without internal brace augmentation

ACTIVE COMPARATOR

This group will only receive a standard ACL reconstruction using a BTB autograft. No suture tape will be added to the graft during the surgical procedure.

Procedure: ACL reconstruction with BTB autograft without internal brace augmentation (suture tape); Other: Standardized Rehabilitation Protocol

Interventions

ACL reconstruction with BTB autograft with internal brace augmentation (suture tape) PROCEDURE

The ACL will be reconstructed using a participant's own patella tendon (BTB autograft), and the graft will be fortified by suture tape during the surgery in order to strengthen it.

ACL reconstruction with internal brace augmentation (suture tape)

ACL reconstruction with BTB autograft without internal brace augmentation (suture tape) PROCEDURE

The ACL will be reconstructed using a participant's own patella tendon (BTB autograft). The graft will not be fortified by suture tape in this group. It will be used as is without any modification.

ACL reconstruction without internal brace augmentation

Standardized Rehabilitation Protocol OTHER

Participants will undergo a standardized rehabilitation protocol with twice weekly physical therapy

ACL reconstruction with internal brace augmentation (suture tape); ACL reconstruction without internal brace augmentation

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (10)

• 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.

  PMID: 25086064 BACKGROUND

• 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.

  PMID: 19732639 BACKGROUND

• 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.

  PMID: 19005197 BACKGROUND

• 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.

  PMID: 2285086 BACKGROUND

• 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.

  PMID: 33539983 BACKGROUND

• 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.

  PMID: 31167738 BACKGROUND

• 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.

  PMID: 33144236 BACKGROUND

• 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.

  PMID: 25620500 BACKGROUND

• 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.

  PMID: 28224069 BACKGROUND

• 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.

  PMID: 34990759 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• David P Trofa, MD

  Associate Professor of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David P Trofa, MD

CONTACT

212 305 5974; dpt2103@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to the ACL reconstruction without internal bracing group (control) or to the ACL reconstruction with internal bracing (experimental).

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 8, 2022
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2032
• Study Completion (Estimated): September 1, 2032
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)