AzTrials
AzTrials

Anterior Cruciate Ligament TearNCT05673356

Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Bone Autograft

A study testing Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB) in people with Anterior Cruciate Ligament Tear and Anterior Cruciate Ligament Injuries, run by Artromedical Konrad Malinowski Clinic at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Anterior cruciate ligament injuries are one of the most common sports knee injuries. Their effect on the knee joint can be detrimental with patients experiencing instability and progressive damage of the intraarticular structures. Therefore, anterior cruciate ligament reconstruction (ACLR) is often indicated. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 sitePoland
Study dates
28 Aug 2020to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptomatic knee anterior and rotatory instability after ACL injury;
  • Primary ACLR cases

Who cannot join

  • Active inflammation of the knee;
  • Revision cases;
  • Additional PLC, PCL or PFJ injuries (MCL and meniscal lesions are not exclusion criteria);
  • Fractures around the knee

Trial locations and contacts

1 site in 1 country.

Konrad Malinowski, MD PhD contact

+48 509812212

malwin8@wp.pl

Poland1 site, 1 recruiting

  • Artromedical Orthopaedic Clinic

    Bełchatów, Łódź Voivodeship, 97-400

    Konrad Malinowski, MD PhD, +48 509 812 212, malwin8@wp.pl

    Recruiting

Other trials in Poland

About this study

Anterior cruciate ligament injuries are one of the most common sports knee injuries. Their effect on the knee joint can be detrimental with patients experiencing instability and progressive damage of the intraarticular structures. Therefore, anterior cruciate ligament reconstruction (ACLR) is often indicated. Multiple graft option exist, including autograft, allograft and xenograft tissues, with autografts being considered as a first-choice source of reconstructed ligament in most cases. Two most common harvested autografts are hamstring tendons (semitendinosus or semitendinosus and gracilis tendons; ST or STG) and patellar tendon with two bone blocks (bone - patellar tendon - bone; BPTB). However, in the recent literature there is an increasing trend towards use of quadriceps tendon autograft (QT). Multiple techniques of harvesting this graft were described, including both partial and complete thickness of the tendon. Another issue is whether bone block from the upper pole of the patella is harvested along with the soft tissues (quadriceps tendon bone graft, QTB).

The aim of this study is to add to the body of knowledge concerning full-thickness quadriceps tendon-bone autograft (QTB) used in ACLR. The primary outcome consists of The International Knee Documentation Committee Questionnaire (IKDC), the Knee injury and Osteoarthritis Outcome Score (KOOS) and retear rate.

Being tested
Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB)
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB)Procedure or surgery

    Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB) will be performed in these patients. QTB autografts will be harvested as described in the published technique: K. Malinowski, J. Paszkowski, M. Mostowy, A. Góralczyk, R.F. LaPrade, K. Hermanowicz, Quadriceps Tendon-Bone Full-Thickness Autograft: Reproducible and Easy Harvesting Technique Using Simple Surgical Tools, Arthrosc. Tech. 10 (2021) e1165-e1172. https://doi.org/10.1016/j.eats.2021.01.003. ACLR will be performed utilizing anteromedial technique with management of any accompanying intraarticular lesions.

Study groups in NCT05673356
Study groupRoleWhat they receive
Main arm of the studyExperimentalArthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB) will be performed in these patients.
Receives: Procedure: Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knee stability

    Anterior and anterolateral rotatory knee stability assessed by the means of instrumented Lachman test and pivot-shift test.

    Measured: At the 12 month of the follow-up.

  2. Knee stability

    Anterior and anterolateral rotatory knee stability assessed by the means of instrumented Lachman test and pivot-shift test.

    Measured: At the 24 month of the follow-up.

Secondary outcomes (8)

  1. The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)

    Min of 0 max of 87 points, higher scores mean a better outcome

    Measured: At the 12 month of the follow-up.

  2. The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)

    Min of 0 max of 87 points, higher scores mean a better outcome

    Measured: At the 24 month of the follow-up.

  3. The functional assessment with the Knee injury and Osteoarthritis Outcome Score

    Min of 0 max of 100 points, higher scores mean a better outcome

    Measured: At the 12 month of the follow-up.

  4. The functional assessment with the Knee injury and Osteoarthritis Outcome Score

    Min of 0 max of 100 points, higher scores mean a better outcome

    Measured: At the 24 month of the follow-up.

  5. Retear rate

    Rate of patients with retear of the reconstructed ligament

    Measured: At the 12 month of the follow-up.

  6. Retear rate

    Rate of patients with retear of the reconstructed ligament

    Measured: At the 24 month of the follow-up.

  7. ROM

    Knee range of motion assessed by the means of goniometer.

    Measured: At the 12 month of the follow-up.

  8. ROM

    Knee range of motion assessed by the means of goniometer.

    Measured: At the 24 month of the follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2023
  2. Study start28 Aug 2020
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group: Clinical trials with a single arm.
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05673356
Sponsor's protocol ID
2-pro-ar-2022
Status last verified
Jan 2023
First submitted
4 Jan 2023
Last updated
11 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Malinowski K, Paszkowski J, Mostowy M, Goralczyk A, LaPrade RF, Hermanowicz K. Quadriceps Tendon-Bone Full-Thickness Autograft: Reproducible and Easy Harvesting Technique Using Simple Surgical Tools. Arthrosc Tech. 2021 Mar 18;10(4):e1165-e1172. doi: 10.1016/j.eats.2021.01.003. eCollection 2021 Apr.

    PubMed 33981566

  • Lind M, Nielsen TG, Soerensen OG, Mygind-Klavsen B, Fauno P. Quadriceps tendon grafts does not cause patients to have inferior subjective outcome after anterior cruciate ligament (ACL) reconstruction than do hamstring grafts: a 2-year prospective randomised controlled trial. Br J Sports Med. 2020 Feb;54(3):183-187. doi: 10.1136/bjsports-2019-101000. Epub 2019 Nov 8.

    PubMed 31704697

  • Slone HS, Romine SE, Premkumar A, Xerogeanes JW. Quadriceps tendon autograft for anterior cruciate ligament reconstruction: a comprehensive review of current literature and systematic review of clinical results. Arthroscopy. 2015 Mar;31(3):541-54. doi: 10.1016/j.arthro.2014.11.010. Epub 2014 Dec 25.

    PubMed 25543249

  • Mehran N, Damodar D, Shu Yang J. Quadriceps Tendon Autograft in Anterior Cruciate Ligament Reconstruction. J Am Acad Orthop Surg. 2020 Jan 15;28(2):45-52. doi: 10.5435/JAAOS-D-19-00032.

    PubMed 31305357

  • Lund B, Nielsen T, Fauno P, Christiansen SE, Lind M. Is quadriceps tendon a better graft choice than patellar tendon? a prospective randomized study. Arthroscopy. 2014 May;30(5):593-8. doi: 10.1016/j.arthro.2014.01.012. Epub 2014 Mar 14.

    PubMed 24630956

Questions about this trial

What is this clinical trial studying?

A study testing Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB) in people with Anterior Cruciate Ligament Tear and Anterior Cruciate Ligament Injuries, run by Artromedical Konrad Malinowski Clinic at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Konrad Malinowski, MD PhD (+48 509812212, malwin8@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee stability (time frame: At the 12 month of the follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05673356, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.

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