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Anterior Cruciate Ligament Reconstruction Hybrid Remnant Repair

Primary Purpose

Anterior Cruciate Ligament Tear

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACL Reconstruction with Hybrid Remnant Repair
ACL Reconstruction without Hybrid Remnant Repair
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Tear focused on measuring ACL, hybrid remnant repair, Anterior Cruciate Ligament

Eligibility Criteria

13 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Henry Ford HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hybrid Remnant Repair

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Subject proprioceptive ability
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.
Subject quadriceps strength
Patients will be subjected to knee extension testing utilizing a dynamometer.
Patient-reported outcomes (PROMIS forms)
Patients will fill out PROM questionnaires in alignment with their clinical visits.
Subject range-of-motion
Range of motion will be assessed with a goniometer.
Return-to-sport (time from surgery)
Time it takes for patient to return to sport or physical activity formerly participating in prior to ACLR

Full Information

First Posted
August 7, 2022
Last Updated
July 22, 2023
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05494073
Brief Title
Anterior Cruciate Ligament Reconstruction Hybrid Remnant Repair
Official Title
Anterior Cruciate Ligament Reconstruction Hybrid Remnant Repair Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Tear
Keywords
ACL, hybrid remnant repair, Anterior Cruciate Ligament

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hybrid Remnant Repair
Arm Type
Experimental
Arm Description
Patients in this arm will have an ACL reconstruction with preservation and incorporation of the the ACL remnant.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients in this arm will have a ACL reconstruction where the ACL remnant is not incorporated into the graft.
Intervention Type
Procedure
Intervention Name(s)
ACL Reconstruction with Hybrid Remnant Repair
Intervention Description
The intervention includes the incorporation of the host ACL remnant into the graft. The intervention hopefully
Intervention Type
Procedure
Intervention Name(s)
ACL Reconstruction without Hybrid Remnant Repair
Intervention Description
ACL reconstruction without preservation or incorporation of host ACL remnant
Primary Outcome Measure Information:
Title
Post-operative imaging (MRI) graft incorporation
Description
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.
Time Frame
1 year post ACLR
Secondary Outcome Measure Information:
Title
Subject proprioceptive ability
Description
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.
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.
Title
Subject quadriceps strength
Description
Patients will be subjected to knee extension testing utilizing a dynamometer.
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.
Title
Patient-reported outcomes (PROMIS forms)
Description
Patients will fill out PROM questionnaires in alignment with their clinical visits.
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.
Title
Subject range-of-motion
Description
Range of motion will be assessed with a goniometer.
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.
Title
Return-to-sport (time from surgery)
Description
Time it takes for patient to return to sport or physical activity formerly participating in prior to ACLR
Time Frame
Variable depending on patients individual recovery. 6 weeks, 3 months, 6 months, 12 months since post operative date.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua P Castle, MD
Phone
616-446-6711
Email
jcastle1@hfhs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew A Gasparro, BS
Phone
714-931-4604
Email
mgaspar1@hfhs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vasilios Moutzouros, MD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua P Castle, MD
Phone
616-446-6711
Email
jcastle1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Matthew A Gasparro, BS
Phone
7149314604
Email
mgaspar1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Joshua P Castle, MD
First Name & Middle Initial & Last Name & Degree
Matthew A Gasparro, BS
First Name & Middle Initial & Last Name & Degree
Vasilios Moutzouros, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not foresee the need to share any individual participant data (IPD) at this time.
Citations:
PubMed Identifier
28205075
Citation
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.
Results Reference
background
PubMed Identifier
29589505
Citation
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.
Results Reference
background
PubMed Identifier
32099783
Citation
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.
Results Reference
background
PubMed Identifier
32904857
Citation
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.
Results Reference
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Anterior Cruciate Ligament Reconstruction Hybrid Remnant Repair

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