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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods for reconstructing a torn ACL, using either a graft from the quadriceps tendon (Quad tendon) or the patellar tendon (BTB). The goal is to determine which method is more effective. Individuals diagnosed with an ACL injury and planning surgery may be suitable for this trial. Participants should be able to adhere to a physical therapy plan after surgery. As an unphased trial, this study allows participants to contribute to valuable research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the Quad tendon and BTB (bone-patellar tendon-bone) grafts are safe choices for ACL (anterior cruciate ligament) reconstruction. Studies have found that the Quad tendon is safe, with few complications. For example, one study reported fewer post-surgery issues and a lower chance of re-tearing with the Quad tendon graft. Another study noted no tears of the Quad tendon during the study period.

The BTB graft is also a well-known and safe method for ACL reconstruction. Research indicates it is commonly used and considered safe. One study found no major difference in complication rates between the BTB and Quad tendon grafts, suggesting both options are similarly safe.

In summary, both the Quad tendon and BTB grafts are generally well-tolerated and have a strong safety record in ACL reconstruction procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using quad tendon and BTB tendon grafts for ACL reconstruction because each offers unique benefits. Unlike traditional hamstring grafts, the quad tendon graft provides a larger graft size, which may enhance stability and strength. On the other hand, the BTB tendon graft is valued for its bone-to-bone healing properties, which can potentially lead to a quicker and stronger integration with the knee joint. These graft options aim to improve recovery times and outcomes for patients needing ACL reconstruction.

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

This trial will compare the effectiveness of two graft options for ACL reconstruction: the quad tendon and the BTB (bone-patellar tendon-bone) grafts. Studies have shown that both grafts perform well for ACL reconstruction. Research suggests that the quad tendon, used in one arm of this trial, often enables a quicker return to sports and has a lower retear risk compared to other grafts. Data on the BTB graft, used in another arm, indicates that many individuals return to sports, with a retear rate of about 7.5%. Both grafts yield similar results in terms of patient satisfaction and complication rates. Overall, both options are considered successful for ACL repair. ^{3 6 7 8 9}

Who Is on the Research Team?

Amit Momaya, MD

Principal Investigator

Department of Orthopaedic Surgery, University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8239981/

Return to Sport After Bone–Patellar Tendon– ... Competitive high school athletes treated with BTB autograft ACLR reported high rates of RTS, high satisfaction, and a retear rate of 7.5%. The ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2059775423005928

Outcomes of bone-patellar tendon-bone autograft and ... Data on 23 patients undergoing BPTB autograft ACLR and 14 undergoing QT autograft ACLR was available. Average age was 18.7 years, and average follow up was 4.8 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25547048/

A meta-analysis of bone-patellar tendon-bone autograft ... The objective of this study was to evaluate the effectiveness of BPTB autografts versus 4SHT autografts for the reconstruction of ACL.

4. journals.lww.com journals.lww.com/md-journal/fulltext/2020/11250/outcome_of_bone_patellar_tendon_bone_vs_hamstring.85.aspx

Outcome of bone–patellar tendon–bone vs hamstring ... The HT autograft for ACL reconstruction carries a lower risk of complications, such as anterior knee pain, kneeling pain, and extension loss, but an increased ...

5. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(22)00232-8/fulltext

Regarding “No Difference in Complication Rates or Patient ... No difference in complication rates or patient-reported outcomes between bone–patellar tendon–bone and quadriceps tendon autograft for anterior cruciate ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7233711/

ACL reconstruction using a bone patellar tendon bone (BPTB ... The objective of this study was to evaluate the medium-term clinical outcomes of ACL reconstruction comparing patients managed with bone patellar tendon bone ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2212628725001987

Bone−Patellar Tendon−Bone Autograft in Anterior Cruciate ... The bone–patellar tendon–bone (BPTB) autograft technique has become the most widely adopted approach for anterior cruciate ligament reconstruction (ACLR)

8. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(25)00365-2/fulltext

Anterior Cruciate Ligament Reconstruction With Bone– ... In this article, we detail 10 technical pearls that surgeons should consider to enhance operative workflow and optimize success during ACLR with ...

9. nature.com nature.com/articles/s41598-023-33899-1

Bone-patellar tendon-bone versus two- and four-strand ... The present study compared BPTB, 2SHT, and 4SHT for ACL reconstruction in terms of joint laxity, patient reported outcome measures (PROMs), rate of failure and ...