Anterior Cruciate Ligament TearNCT05494073
Anterior Cruciate Ligament Reconstruction Hybrid Remnant Repair
A study testing ACL Reconstruction with Hybrid Remnant Repair and ACL Reconstruction without Hybrid Remnant Repair in people with Anterior Cruciate Ligament Tear, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament Tear
- What is being tested?
- ACL Reconstruction with Hybrid Remnant Repair and ACL Reconstruction without Hybrid Remnant Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2021to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterior Cruciate Ligament Reconstruction Hybrid Remnant Repair Randomized Control Trial
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Tear
- Being tested
- ACL Reconstruction with Hybrid Remnant Repair, ACL Reconstruction without Hybrid Remnant Repair
- Keywords
- ACL, hybrid remnant repair, Anterior Cruciate Ligament
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL Reconstruction with Hybrid Remnant RepairProcedure or surgery
The intervention includes the incorporation of the host ACL remnant into the graft. The intervention hopefully
ACL Reconstruction without Hybrid Remnant RepairProcedure or surgery
ACL reconstruction without preservation or incorporation of host ACL remnant
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Remnant Repair | Experimental | Patients in this arm will have an ACL reconstruction with preservation and incorporation of the the ACL remnant. Receives: 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. Receives: Procedure: ACL Reconstruction without Hybrid Remnant Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year post ACLR
Secondary outcomes (5)
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.
Measured: 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
Patients will be subjected to knee extension testing utilizing a dynamometer.
Measured: 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)
Patients will fill out PROM questionnaires in alignment with their clinical visits.
Measured: 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
Range of motion will be assessed with a goniometer.
Measured: 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)
Time it takes for patient to return to sport or physical activity formerly participating in prior to ACLR
Measured: Variable depending on patients individual recovery. 6 weeks, 3 months, 6 months, 12 months since post operative date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start13 Dec 2021
- Primary completionSep 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament TearStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasilios Moutzouros, Henry Ford Health System
- Investigators
- Vasilios Moutzouros, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494073
- Sponsor's protocol ID
- 14969-01
- Status last verified
- Jun 2025
- First submitted
- 7 Aug 2022
- Last updated
- 8 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not foresee the need to share any individual participant data (IPD) at this time.
Publications
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.
PubMed 28205075Hexter 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.
PubMed 29589505Tensho 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.
PubMed 32099783Diaz 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.
PubMed 32904857
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Cruciate Ligament Reconstruction Hybrid Remnant Repair Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05494073
- Acronym / sponsor ID
- 14969-01
- Conditions
- Anterior Cruciate Ligament Tear
- Keywords
- ACL, hybrid remnant repair, Anterior Cruciate Ligament
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Remnant Repair | Experimental | Procedure: ACL Reconstruction with Hybrid Remnant RepairPatients in this arm will have an ACL reconstruction with preservation and incorporation of the the ACL remnant. |
| Control | Active comparator | Procedure: ACL Reconstruction without Hybrid Remnant RepairPatients in this arm will have a ACL reconstruction where the ACL remnant is not incorporated into the graft. |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL Reconstruction with Hybrid Remnant RepairThe intervention includes the incorporation of the host ACL remnant into the graft. The intervention hopefully | Procedure or surgery | Hybrid Remnant Repair |
| ACL Reconstruction without Hybrid Remnant RepairACL reconstruction without preservation or incorporation of host ACL remnant | Procedure or surgery | Control |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Background: PubMed 28205075Samuelsen 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.
- Background: PubMed 29589505Hexter 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.
- Background: PubMed 32099783Tensho 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.
- Background: PubMed 32904857Diaz 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.
- Individual participant dataSharing planned: No. We do not foresee the need to share any individual participant data (IPD) at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasilios Moutzouros, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL Reconstruction with Hybrid Remnant Repair and ACL Reconstruction without Hybrid Remnant Repair in people with Anterior Cruciate Ligament Tear, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative imaging (MRI) graft incorporation (time frame: 1 year post ACLR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05494073, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.