Anterior Cruciate Ligament Reconstruction Hybrid Remnant Repair

NCT05494073 | Active Not Recruiting

• 1 other identifier: 14969-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients between 14-60 years of age who will undergo an anterior cruciate ligament (ACL) reconstruction between Nov 1, 2021- Dec 31, 2023, will have their charts reviewed be approached in clinic when the surgery is scheduled regarding their participation in this study. At the time of consent, patients will be randomized to a group via a computerized randomization process, either the experimental hybrid remnant repair (HRR) or traditional ACL reconstruction with ACL stump debridement. Routine postoperative data will be collected at regularly scheduled post-operative and physical therapy appointments including range of motion, pain, patient-reported outcomes, return-to-sport tests, and proprioceptive data. Additionally, patients will be asked to undergo a post-operative MRI between 9 and 15 months following the date of their surgery. Radiologists reading the MRIs will be blinded to which group the patient is in. The primary outcome measure is graft incorporation between the two groups.

Conditions

Anterior Cruciate Ligament Tear

Keywords

ACL; hybrid remnant repair; Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (1)

• Post-operative imaging (MRI) graft incorporation

  We hypothesize patients undergoing HRR ACLR will have better incorporation with improved vascularity compared to patients undergoing a traditional ACLR. We hypothesize that this will lead to improved proprioceptive abilities and improved patient reported outcomes, which may reduce the time required to be cleared to return-to-sport and resume usual activities of daily living.

  1 year post ACLR

Secondary Outcomes (5)

• Subject proprioceptive ability

  Collected at intervals during post-operative period once cleared by physician and physical therapy. 6 weeks, 3 months, 6 months, 12 months since post operative date.

• Subject quadriceps strength

  Collected pre-operatively and at intervals during post-operative period once cleared by physician and physical therapy.6 weeks, 3 months, 6 months, 12 months since post operative date.

• Patient-reported outcomes (PROMIS forms)

  Collected pre-operatively and at intervals during post-operative clinic visits. 6 weeks, 3 months, 6 months, 12 months since post operative date.

• Subject range-of-motion

  Collected pre-operatively and at intervals during post-operative clinic visits. 6 weeks, 3 months, 6 months, 12 months since post operative date.

• Return-to-sport (time from surgery)

  Variable depending on patients individual recovery. 6 weeks, 3 months, 6 months, 12 months since post operative date.

Study Arms (2)

Hybrid Remnant Repair

EXPERIMENTAL

Patients in this arm will have an ACL reconstruction with preservation and incorporation of the the ACL remnant.

Procedure: ACL Reconstruction with Hybrid Remnant Repair

Control

ACTIVE COMPARATOR

Patients in this arm will have a ACL reconstruction where the ACL remnant is not incorporated into the graft.

Procedure: ACL Reconstruction without Hybrid Remnant Repair

Interventions

ACL Reconstruction with Hybrid Remnant Repair PROCEDURE

The intervention includes the incorporation of the host ACL remnant into the graft. The intervention hopefully

Hybrid Remnant Repair

ACL Reconstruction without Hybrid Remnant Repair PROCEDURE

ACL reconstruction without preservation or incorporation of host ACL remnant

Control

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 14-65 will undergo an anterior cruciate ligament (ACL) reconstruction from June 1,2021-Dec 31,2023 will be chart reviewed and asked about participating in the study in Dr. Moutzouros's clinic at a routine pre-operative clinic appointment .
• There will be 100 subjects who are consented, 50 in each group (Arm A- HRR ACLR; Arm B- traditional ACLR with stump debridement).

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (4)

• Samuelsen BT, Webster KE, Johnson NR, Hewett TE, Krych AJ. Hamstring Autograft versus Patellar Tendon Autograft for ACL Reconstruction: Is There a Difference in Graft Failure Rate? A Meta-analysis of 47,613 Patients. Clin Orthop Relat Res. 2017 Oct;475(10):2459-2468. doi: 10.1007/s11999-017-5278-9.

  PMID: 28205075 BACKGROUND

• Hexter AT, Thangarajah T, Blunn G, Haddad FS. Biological augmentation of graft healing in anterior cruciate ligament reconstruction: a systematic review. Bone Joint J. 2018 Mar 1;100-B(3):271-284. doi: 10.1302/0301-620X.100B3.BJJ-2017-0733.R2.

  PMID: 29589505 BACKGROUND

• Tensho K, Iwaasa T, Shimodaira H, Koyama S, Horiuchi H, Takahashi J, Saito N. Anatomical Remnant-Preserving Double-Bundle ACL Reconstruction With a New Remnant Augmentation Technique. Arthrosc Tech. 2020 Jan 24;9(2):e283-e290. doi: 10.1016/j.eats.2019.10.009. eCollection 2020 Feb.

  PMID: 32099783 BACKGROUND

• Diaz RMM, Rezende FC, Moscon AC, Franciozi CEDS, Martimbianco ALC, Duarte A. Return to Sports after ACL Reconstruction with Resection or Remnant-Preserving Technique. Rev Bras Ortop (Sao Paulo). 2020 Aug;55(4):432-437. doi: 10.1055/s-0039-3402461. Epub 2020 Feb 7.

  PMID: 32904857 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Vasilios Moutzouros, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Vasilios Moutzouros M.D. Principle Investigator

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 9, 2022
• Study Start: December 13, 2021
• Primary Completion: September 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)