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NCT Number: NCT05494073

Anterior Cruciate Ligament Reconstruction Hybrid Remnant Repair

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

13 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

About this study

The purpose of this study is to examine the efficacy of a hybrid remnant repair (HRR) anterior cruciate ligament reconstruction (ACLR) with a traditional ACLR. Orthopedic surgeons are consistently looking for ways to improve outcomes following ACLR. Previous research has focused on different graft harvesting techniques and selection as well as biological augmentation of the graft. Recently, as reconstruction techniques have improved the anatomic accuracy of the reconstruction, there has been a renewed interest in remnant-preserving techniques. Surgeons in the sports medicine department are trained and have been performing HRR for several months at this point. The investigators are interested in comparing the results of patients who underwent HRR ACLR compared to a traditional ACLR.

The specific aim of this investigation is to determine the efficacy of ACL reconstruction with HRR to the standard ACL reconstruction with stump debridement. This study will specifically focus on whether patients who underwent HRR ACLR achieve superior incorporation of the graft, proprioceptive abilities, and improved patient-reported outcomes compared to traditional ACLR. If this procedure provides superior outcomes, it will benefit patients who have an ACL tear with a vascularized remnant stump remaining. The investigators will access information in the Henry Ford electronic medical records and review patient charts to consent patients undergoing ACL reconstruction between June 1, 2021- Dec 31, 2023. The investigators will record intraoperative data including date of surgery, type of graft used, whether or not there was a prior surgery; post-operative data including strength, range of motion, and patient-reported outcomes; all of which are routinely collected or documented. Additionally, between 6 and 15 months postoperatively, patients will undergo postoperative magnetic resonance imaging (MRI) to determine the incorporation of the graft and ACL remnant.

The investigators hypothesize patients undergoing HRR ACLR will have better incorporation with improved vascularity compared to patients undergoing a traditional ACLR. The investigators 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Patients will be excluded if they suffered concomitant medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL) injury as well as patients who did not undergo HRR ACLR. Additional exclusion criteria includes poor follow-up to post-operative clinic appointments.

Treatment and study plan

ACL Reconstruction with Hybrid Remnant Repair

Procedure

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

ACL Reconstruction without Hybrid Remnant Repair

Procedure

ACL reconstruction without preservation or incorporation of host ACL remnant

Primary outcomes

  1. Post-operative imaging (MRI) graft incorporation

    Time frame: 1 year post ACLR

    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.

Secondary outcomes

  1. Subject proprioceptive ability

    Time frame: 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.

    Patients will be put through a series of tests in line with their clinic visits to objectively test for proprioception. Data will be analyzed and compared between hybrid remnant repair ALCR and traditional ACLR. Tests consist of single leg triple hop for distance and single leg 6 meter hop for time.

  2. Subject quadriceps strength

    Time frame: 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.

    Patients will be subjected to knee extension testing utilizing a dynamometer.

  3. Patient-reported outcomes (PROMIS forms)

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

    Patients will fill out PROM questionnaires in alignment with their clinical visits.

  4. Subject range-of-motion

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

    Range of motion will be assessed with a goniometer.

  5. Return-to-sport (time from surgery)

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

    Time it takes for patient to return to sport or physical activity formerly participating in prior to ACLR

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

Anterior Cruciate Ligament Reconstruction Hybrid Remnant Repair Randomized Control Trial

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Aug 9, 2022
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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