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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of ACL reconstruction surgery to determine which one promotes better knee healing. It compares Hybrid Remnant Repair (HRR), which preserves some original ACL tissue, with the traditional method that removes it. Researchers will assess how well the new ACL graft integrates into the knee over time. Individuals undergoing ACL reconstruction surgery without other knee ligament injuries may be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to innovative surgical research that could enhance future ACL reconstruction outcomes.

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 prior data suggests that these ACL reconstruction methods are safe?

Research has shown that the Hybrid Remnant Repair (HRR) method for ACL reconstruction is generally well-received by patients. In earlier studies, individuals who underwent this new method reported results similar to those who had traditional surgery. Both groups regained full knee movement and experienced no major differences in complications after one year. This suggests that HRR is as safe as the traditional method. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the ACL reconstruction with hybrid remnant repair because it offers a fresh approach to healing ACL injuries. Unlike the standard ACL reconstruction that doesn't preserve the original ligament remnants, this technique incorporates them into the graft. This could potentially enhance the healing process and provide better knee stability and function. By preserving more of the original ligament structure, the hybrid remnant repair may also reduce recovery time and improve long-term outcomes for patients.

What evidence suggests that this trial's treatments could be effective for ACL injury?

This trial will compare two methods of ACL reconstruction: one with Hybrid Remnant Repair (HRR) and one without. Research has shown that the HRR method for ACL surgery can lead to similar patient satisfaction and full movement as traditional methods. Studies found no difference in complication rates one year after surgery compared to the traditional approach. This less invasive technique combines different surgical methods to enhance recovery. The aim is to preserve more of the original ligament, potentially helping the new tissue integrate with the body. Early results suggest that HRR could be a promising alternative to traditional ACL surgery methods. ^{1 2 6 7 8}

Who Is on the Research Team?

Vasilios Moutzouros, MD

Principal Investigator

Henry Ford Health System

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10847033/

Anterior Cruciate Ligament Hybrid Remnant Preservation ... ACL HRPR is associated with equivalent patient-reported outcomes, full ROM, and no differences in complications rates after 1 year compared with control ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05494073

Anterior Cruciate Ligament Reconstruction Hybrid ... 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.

3. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(24)00420-1/fulltext

A Modified Hybrid Repair Technique of Combined All ... ACL, anterior cruciate ligament. In conclusion, the modified hybrid repair technique is less invasive and effectively makes up for the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2212628724004201

A Modified Hybrid Repair Technique of Combined All ... We describe an advanced hybrid technique that combines all-inside single-bundle reconstruction and primary repair with augmentation.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11168252/

Clinical Results of Primary Repair Versus Reconstruction of ... The incidence of revision surgery was 11.4% in the ACL repair cohort and 5.8% in the ACLR cohort. The RR of revision surgery was significantly ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8322566/

Hybrid Remnant-Sparing Anterior Cruciate Ligament Repair ... Despite the 80% to 90% success rate of contemporary ACLR techniques, further improvements can be made. A significant number of ACL tears occur ...

7. trialx.com trialx.com/clinical-trials/listings/264293/anterior-cruciate-ligament-reconstruction-hybrid-remnant-repair/

Anterior Cruciate Ligament Reconstruction Hybrid ... 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.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2212628720300669

A Hybrid Repair Technique Combining Single-Bundle ... Recently, favorable outcomes of primary anterior cruciate ligament (ACL) repair have been reported in patients with proximal tears and good tissue quality.