ACL Reconstruction for ACL Injury
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment ACL Reconstruction with Hybrid Remnant Repair for ACL Injury?
Research suggests that preserving the remnant tissue during ACL reconstruction can enhance healing and improve knee function by maintaining proprioception (the body's ability to sense movement and position) and promoting better biological healing. Some studies have shown encouraging results with remnant-preserving techniques, indicating potential for faster recovery and improved outcomes compared to traditional methods.12345
Is ACL reconstruction generally safe for humans?
Research indicates that ACL reconstruction, including techniques with remnant preservation, is generally safe, though preserving the remnant may increase technical challenges and complications. Studies show no significant long-term safety differences between standard and minimal graft debridement techniques.13678
How does ACL reconstruction with hybrid remnant repair differ from other treatments for ACL injury?
ACL reconstruction with hybrid remnant repair is unique because it preserves and re-tensions the remaining parts of the torn ligament, which can improve the strength and healing of the new ligament. This approach may enhance the recovery of movement sense (proprioception) and blood supply to the graft, potentially leading to better outcomes compared to traditional ACL reconstruction methods that do not preserve the remnant.49101112
What is the purpose of this 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.
Research Team
Vasilios Moutzouros, MD
Principal Investigator
Henry Ford Health System
Eligibility Criteria
This trial is for individuals aged 14-65 who need ACL reconstruction surgery due to injury or tear, and can attend follow-up appointments. It's not suitable for those with additional ligament injuries (MCL, LCL, PCL) or who won't have the specific HRR technique.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo ACL reconstruction with either hybrid remnant repair or traditional ACL reconstruction
Post-operative Monitoring
Routine postoperative data collection at scheduled appointments including range of motion, pain, patient-reported outcomes, and proprioceptive data
Follow-up
Participants undergo post-operative MRI to assess graft incorporation
Treatment Details
Interventions
- ACL Reconstruction with Hybrid Remnant Repair
- ACL Reconstruction without Hybrid Remnant Repair
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry Ford Health System
Lead Sponsor