ACL Reconstruction for ACL Injury

Overseen By Matthew A Gasparro, BS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Disqualifiers: MCL, LCL, PCL injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: Surgery date

100 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{4 9 10 11 12}

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

I am part of a group of 100 people divided into two treatment types for ACL repair.

I am between 14-65 years old and having ACL surgery in Dr. Moutzouros's clinic between June 1, 2021 and Dec 31, 2023.

Exclusion Criteria

Patients with poor follow-up to post-operative clinic appointments

I am not having ACL reconstruction with a hamstring tendon.

I have an injury to my knee's MCL, LCL, or PCL.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ACL reconstruction with either hybrid remnant repair or traditional ACL reconstruction

Surgery date

1 visit (in-person)

Post-operative Monitoring

Routine postoperative data collection at scheduled appointments including range of motion, pain, patient-reported outcomes, and proprioceptive data

12 months

Multiple visits (in-person) at 6 weeks, 3 months, 6 months, 12 months

Follow-up

Participants undergo post-operative MRI to assess graft incorporation

9-15 months post-surgery

1 visit (in-person)

Treatment Details

Interventions

• ACL Reconstruction with Hybrid Remnant Repair
• ACL Reconstruction without Hybrid Remnant Repair

Trial Overview The study compares two ACL reconstruction methods: one using Hybrid Remnant Repair (HRR) and the other a traditional approach without HRR. Participants are randomly assigned to either group and monitored through post-op visits and MRI scans.

Participant Groups

Group I: Hybrid Remnant Repair Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Hybrid Remnant-Sparing Anterior Cruciate Ligament Repair-Reconstruction. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Research advances in anterior cruciate ligament reconstructions with remnant preservation]. [2013]

3. Italy pubmed.ncbi.nlm.nih.gov

Remnant preservation in anterior cruciate ligament reconstruction versus standard techniques: a meta-analysis of randomized controlled trials. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Biomechanical and Biological Findings Between Acute Anterior Cruciate Ligament Reconstruction With and Without an Augmented Remnant Repair: A Comparative in Vivo Animal Study. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Arthroscopic Primary Repair of the Anterior Cruciate Ligament With Single-Bundle Graft Augmentation. [2020]

6. Singapore pubmed.ncbi.nlm.nih.gov

Clinical outcome of a new remnant augmentation technique with anatomical double-bundle anterior cruciate ligament reconstruction: Comparison among remnant preservation, resection, and absent groups. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of anterior cruciate ligament reconstruction with preservation only versus remnant tensioning technique. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

No clinical difference in 10-year outcomes between standard and minimal graft debridement techniques in patients undergoing anterior cruciate ligament reconstruction using autologous hamstrings: a randomized controlled trial. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament remnant-preserving and re-tensioning reconstruction: a biomechanical comparison study of three different re-tensioning methods in a porcine model. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

The evolution of ACL reconstruction over the last fifty years. [2022]

11. China pubmed.ncbi.nlm.nih.gov

[Current concepts in arthroscopic reconstruction of anterior cruciate ligament with remnant preservation technique]. [2022]

12. France pubmed.ncbi.nlm.nih.gov

ACL tear. [2016]