An interventional study of ACL Reconstruction with Hybrid Remnant Repair and ACL Reconstruction without Hybrid Remnant Repair in Anterior Cruciate Ligament Tear, sponsored by Henry Ford Health System. Active, not recruiting at 1 site in United States. Open to participants aged 13 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Henry Ford Health System · Not applicable, Interventional, and Treatment
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.
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.
512 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 164 are open to participants now.
This study's planned enrollment of 100 is above the median of 56 across 373 interventional studies indexed under Anterior Cruciate Ligament Injuries.
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Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
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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 in this arm will have an ACL reconstruction with preservation and incorporation of the the ACL remnant.
Procedure: ACL Reconstruction with Hybrid Remnant Repair
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
The intervention includes the incorporation of the host ACL remnant into the graft. The intervention hopefully
ACL reconstruction without preservation or incorporation of host ACL remnant
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.
Time frame: 1 year post ACLR
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.
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
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.
Patient-reported outcomes (PROMIS forms)
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.
Subject range-of-motion
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.
Return-to-sport (time from surgery)
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.
Plan to share: No — We do not foresee the need to share any individual participant data (IPD) at this time.
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Anterior Cruciate Ligament Injuries→
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