Quad Tendon vs BTB Graft for ACL Reconstruction

Overseen By Amit Momaya, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Poor tissue quality, Pregnant, others

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

Compensation: Varies

Number of Visits: 9

Duration: Operative day

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.

What data supports the effectiveness of the treatment Quad Tendon vs BTB Graft for ACL Reconstruction?

Research shows that both quadriceps tendon and bone-patellar tendon-bone grafts provide similar stability and function for ACL reconstruction, with quadriceps tendon grafts resulting in less discomfort at the donor site. ^{1 2 3 4 5}

Is ACL reconstruction using Quad Tendon or BTB Graft safe?

Both Quad Tendon and BTB Grafts are generally safe for ACL reconstruction, but they can have some side effects. BTB Grafts may cause more knee pain at the donor site, while Quad Tendon Grafts tend to have less of this issue. ^{3 6 7 8 9}

How does the Quad Tendon vs BTB Graft treatment for ACL reconstruction differ from other treatments?

The Quad Tendon and BTB Graft treatments for ACL reconstruction are unique because they use different parts of the knee's tendons to repair the ligament, with the Quad Tendon Graft offering similar outcomes to the BTB Graft but with potentially less discomfort at the donor site and more flexibility in adjusting the graft's size. ^{1 2 3 4 10}

What is the purpose of this trial?

The choice of autograft for ACL reconstruction continues to be debated. To date, there has only be one completed randomized controlled trial with quad tendon to BTB and the tendon included a bone plug. There has been no study to date comparing an all soft tissue quad tendon to patellar tendon in a randomized controlled trial for ACL reconstruction.

Research Team

Amit Momaya, MD

Principal Investigator

Department of Orthopaedic Surgery, University of Alabama at Birmingham

Eligibility Criteria

This trial is for skeletally mature individuals under 40 with an ACL injury who are scheduled for autograft reconstruction. It's not suitable for those unlikely to follow physical therapy, needing multiple ligament reconstructions, or wanting to return to sports within 6 months. Pregnant or nursing persons can't join.

Inclusion Criteria

I am a suitable candidate for a procedure using my own tissue for transplantation.

I am under 65 and my bones have stopped growing.

My ACL is not functioning properly.

Exclusion Criteria

Inability to read and write English

High likelihood of remaining non-compliant with physical therapy regimen

Pregnant or nursing

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo ACL reconstruction surgery using either BTB or QT autografts

Operative day

1 visit (in-person)

Post-operative Rehabilitation

Standard of care rehabilitation and mobility instructions are provided, with follow-up appointments at 2 weeks, 6 weeks, 3 months, 6 months, and 9 months

9 months

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 12 months and 24 months

15 months

2 visits (in-person)

Treatment Details

Interventions

• BTB
• Quad tendon

Trial Overview The study compares two types of knee surgery grafts: the quad tendon (all soft tissue) and the patellar tendon (with bone). This randomized controlled trial aims to determine which graft option is better for ACL reconstruction.

Participant Groups

Group I: Quad tendon Active Control 1 Intervention

ACL graft harvested from the quadriceps tendon

Group II: BTB tendon Active Control 1 Intervention

ACL graft harvested from the patellar tendon

BTB is already approved in United States, European Union for the following indications:

Approved in United States as Bone Patellar Tendon Bone Autograft for:

• Anterior Cruciate Ligament (ACL) reconstruction

Approved in European Union as Patellar Tendon Autograft for:

• Anterior Cruciate Ligament (ACL) reconstruction

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

The study analyzed 20 paired human cadaveric knees and found that the quadriceps tendon-patellar bone (QTB) graft is significantly wider and thicker than the bone-patellar tendon-bone (BPTB) graft, suggesting that QTB may provide a more robust structural support for ACL reconstruction.

The results indicate that the BPTB graft can bend more than the QTB at the femoral tunnel aperture, which may influence the choice of graft for achieving optimal anatomical reconstruction of the ACL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACL Graft Matching: Cadaveric Comparison of Microscopic Anatomy of Quadriceps and Patellar Tendon Grafts and the Femoral ACL Insertion Site. Kinoshita, T., Hashimoto, Y., Iida, K., et al.[2022]

In a review of five studies involving 806 patients, both Bone-patellar tendon-bone (BPTB) and quadriceps tendon-bone (QTB) autografts showed similar graft failure rates and joint stability after anterior cruciate ligament (ACL) reconstruction.

However, patients who received QTB grafts experienced significantly less pain at the graft site and while kneeling one year post-surgery, indicating a potential advantage in donor site morbidity for QTB grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quadriceps Tendon-Bone or Patellar Tendon-Bone Autografts When Reconstructing the Anterior Cruciate Ligament: A Meta-analysis. Riaz, O., Aqil, A., Mannan, A., et al.[2018]

A study involving 60 athletes showed that both quadriceps tendon-patellar bone (QTB) and bone-patellar tendon-bone (BPTB) autografts for ACL reconstruction resulted in excellent long-term functional outcomes, with 90% of patients reporting very good or good results after an average of 10 years.

The QTB autograft had significantly lower donor site morbidity compared to the BPTB autograft, with fewer complaints related to kneeling and squatting, highlighting its potential advantages in terms of safety and patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quadriceps tendon vs. patellar tendon autograft for ACL reconstruction using a hardware-free press-fit fixation technique: comparable stability, function and return-to-sport level but less donor site morbidity in athletes after 10 years. Barié, A., Sprinckstub, T., Huber, J., et al.[2021]

A systematic review of 28 studies involving 800 manuscripts found that the overall risk of extensor mechanism complications after ACL reconstruction using either bone-patellar tendon-bone (BTB) or quadriceps tendon (QT) grafts is low, indicating that these graft harvests are generally safe.

However, the study revealed that QT grafts are associated with a higher proportion of patellar fractures (2.03%) and donor tendon ruptures (0.52%) compared to BTB grafts, which had lower rates of these complications (0.57% for patellar fractures and 0.22% for tendon ruptures).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knee Extensor Mechanism Complications After Autograft Harvest in ACL Reconstruction: A Systematic Review and Meta-analysis. Trasolini, NA., Lan, R., Bolia, IK., et al.[2023]

In a study of 6652 patients undergoing ACL reconstruction, the rate of septic arthritis was very low at 0.34%, with the quadriceps tendon autograft (QT) showing the lowest rate at just 0.10%.

While the type of graft used (QT, BTB, HT, or allograft) influenced the rates of septic arthritis, other factors like age, sex, and surgical techniques did not show a significant association with infection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rates of Septic Arthritis After ACL Reconstruction: A Single-Center Analysis Highlighting Quadriceps Tendon Grafts. Özbek, EA., Dadoo, S., Chang, A., et al.[2023]

In a study of 286 patients who underwent anterior cruciate ligament reconstruction using bone-patellar tendon-bone autograft, refilling the patellar bony defect with a bone substitute significantly reduced the prevalence of anterior knee pain (33.3% vs. 51.1%) and lowered pain severity as measured by the visual analog scale (VAS) scores (2.18 vs. 3.13).

The Bone Graft group also experienced fewer complications compared to the No Bone Graft group (21.7% vs. 34.1%), suggesting that using a bone substitute may enhance the safety profile of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone filling decreases donor site morbidity after anterior cruciate ligament reconstruction with bone-patellar tendon-bone autografts. Shichman, I., Baruchi, D., Rachevsky, G., et al.[2023]

In a study of 200 patients who underwent ACL reconstruction with a bone-patellar tendon-bone autograft, only 13.9% reported anterior knee pain at the 2-year follow-up, indicating lower donor site morbidity than previously reported.

The newly developed 10-question donor site morbidity instrument showed that 75.4% of patients had a perfect score, suggesting it may provide a more accurate assessment of donor site symptoms compared to traditional outcome tools like the IKDC and Lysholm scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Scoring Instrument to Assess Donor Site Morbidity After Anterior Cruciate Ligament Reconstruction With a Patellar Tendon Autograft at 2-Year Follow-up Using Contemporary Graft-Harvesting Techniques. Hacken, BA., Keyt, LK., Leland, DP., et al.[2022]

In a study of 80 patients followed for an average of 28 months, single-bundle anatomic anterior cruciate ligament reconstruction using a quadriceps tendon graft (BT) showed similar rotational stability to the traditional bone-patellar tendon-bone graft (BTB) method.

Patients who underwent BTB reconstruction reported significantly more pain and difficulty with kneeling compared to those who had BT reconstruction, suggesting that the quadriceps tendon graft may offer a more comfortable recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo knee rotational stability 2 years after the ACL reconstruction using a quadriceps tendon graft with bone block and bone-patellar tendon-bone graft. Komzák, M., Hart, R., Náhlík, D., et al.[2022]

In a study of high-activity patients undergoing ACL reconstruction, those who received a bone-patellar tendon-bone (BTB) autograft had a significantly higher rate of returning to their preinjury activity levels compared to those with a hamstring tendon autograft, with 17.2% vs. 9.3% at 1 year and 23.3% vs. 13.3% at 2 years.

The increased return to activity with BTB autografts may explain the higher incidence of contralateral ACL injuries observed in these patients, suggesting a potential trade-off between improved activity levels and injury risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher Rate of Return to Preinjury Activity Levels After Anterior Cruciate Ligament Reconstruction With a Bone-Patellar Tendon-Bone Versus Hamstring Tendon Autograft in High-Activity Patients: Results From the New Zealand ACL Registry. Rahardja, R., Love, H., Clatworthy, MG., et al.[2021]

The autogenous quadriceps tendon-bone graft is becoming increasingly popular for knee reconstruction, particularly in anterior cruciate ligament (ACL) surgeries, due to its comparable biomechanical and clinical outcomes to the traditional bone-patellar tendon-bone graft.

This technique not only reduces donor-site morbidity but also allows for better customization of graft length and diameter, making it a versatile option for both primary and revision ACL reconstructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quadriceps Tendon-Bone Full-Thickness Autograft: Reproducible and Easy Harvesting Technique Using Simple Surgical Tools. Malinowski, K., Paszkowski, J., Mostowy, M., et al.[2022]

References

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

ACL Graft Matching: Cadaveric Comparison of Microscopic Anatomy of Quadriceps and Patellar Tendon Grafts and the Femoral ACL Insertion Site. [2022]

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

Quadriceps Tendon-Bone or Patellar Tendon-Bone Autografts When Reconstructing the Anterior Cruciate Ligament: A Meta-analysis. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Quadriceps tendon vs. patellar tendon autograft for ACL reconstruction using a hardware-free press-fit fixation technique: comparable stability, function and return-to-sport level but less donor site morbidity in athletes after 10 years. [2021]

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

Knee Extensor Mechanism Complications After Autograft Harvest in ACL Reconstruction: A Systematic Review and Meta-analysis. [2023]

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

Rates of Septic Arthritis After ACL Reconstruction: A Single-Center Analysis Highlighting Quadriceps Tendon Grafts. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Bone filling decreases donor site morbidity after anterior cruciate ligament reconstruction with bone-patellar tendon-bone autografts. [2023]

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

A Novel Scoring Instrument to Assess Donor Site Morbidity After Anterior Cruciate Ligament Reconstruction With a Patellar Tendon Autograft at 2-Year Follow-up Using Contemporary Graft-Harvesting Techniques. [2022]

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

In vivo knee rotational stability 2 years after the ACL reconstruction using a quadriceps tendon graft with bone block and bone-patellar tendon-bone graft. [2022]

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

Higher Rate of Return to Preinjury Activity Levels After Anterior Cruciate Ligament Reconstruction With a Bone-Patellar Tendon-Bone Versus Hamstring Tendon Autograft in High-Activity Patients: Results From the New Zealand ACL Registry. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Quadriceps Tendon-Bone Full-Thickness Autograft: Reproducible and Easy Harvesting Technique Using Simple Surgical Tools. [2022]