Collateral Ligament, Knee; Sprain (Strain), MedialNCT05489627

Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Knee Instability

A study testing Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement in people with Collateral Ligament, Knee; Sprain (Strain), Medial 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Collateral Ligament, Knee; Sprain (Strain), Medial, Anterior Cruciate Ligament Injuries
What is being tested?: Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 sitePoland
Study dates: 31 Aug 2022to 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 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Symptomatic knee medial and anteromedial rotatory instability associated with anterior and rotatory instability after an MCL + ACL injury
Primary cases

Who cannot join

Active inflammation of the knee
Revision cases
Additional PLC, PCL or PFJ injuries
fractures around the knee
removal of more than ½ of medial or lateral meniscus
contralateral knee injury
cartilage damage ICRS grade III or higher
Non-adherence of the patient to the treatment protocol

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

Other trials in Poland

About this study

The aim of this study is to assess the outcomes of the combined quadriceps tendon-bone (QTB) ACLR and MCLR with anteromedial reinforcement performed as described in the published technique: K. Malinowski, K. Hermanowicz, A. Góralczyk, R.F. LaPrade, Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Instability of the Knee, Arthrosc. Tech. 8 (2019) e807-e814. https://doi.org/10.1016/j.eats.2019.03.019.

Read the detailed description

Medial collateral ligament (MCL) injuries are one of the most common sports knee injuries, commonly occuring together with anterior cruciate ligament (ACL) injuries. Their effect on the knee joint can be detrimental with patients experiencing medial instability and anteromedial rotatory instability (AMRI), leading to progressive damage of the intraarticular structures. While healing potential of medial knee stabilizing structures is relatively high, medial collateral ligament reconstruction (MCLR) is sometimes indicated. Multiple reconstructions techniques were described, including both procedures utilizing native semitendinosus tendon with distal attachment left intact as well as with auto- or allo-grafts. However, in part of these techniques, AMRI is not addressed.

Therefore, the aim of this study is to assess the outcomes of the combined quadriceps tendon-bone (QTB) ACLR and MCLR with anteromedial reinforcement performed as described in the published technique: K. Malinowski, K. Hermanowicz, A. Góralczyk, R.F. LaPrade, Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Instability of the Knee, Arthrosc. Tech. 8 (2019) e807-e814. https://doi.org/10.1016/j.eats.2019.03.019.

The primary outcome consists of The International Knee Documentation Committee Questionnaire (IKDC) and the Knee injury and Osteoarthritis Outcome Score (KOOS).

Conditions: Collateral Ligament, Knee; Sprain (Strain), Medial, Anterior Cruciate Ligament Injuries
Being tested: Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement
Medical subject headings: Sprains and Strains, Anterior Cruciate Ligament Injuries

What participants receive

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

Medial Collateral Ligament Reconstruction With Anteromedial ReinforcementProcedure or surgery
Medial knee instabilities will be addressed in this arm as described in the published technique: K. Malinowski, K. Hermanowicz, A. Góralczyk, R.F. LaPrade, Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Instability of the Knee, Arthrosc. Tech. 8 (2019) e807-e814. https://doi.org/10.1016/j.eats.2019.03.019.
Due to the fact that isolated injury of medial stabilizers of the knees is very rare, included will be patients with concomitant ACL QTB reconstruction and abovedescribed MCL reconstruction. Any accompanying intraarticular injuries such as meniscal lesions will be addressed as well.

Study groups in NCT05489627
Study group	Role	What they receive
Main arm of the study	Experimental	Medial knee instabilities will be addressed in this arm. Due to the fact that isolated injury of medial stabilizers of the knees is very rare, included will be patients with D concomitant ACL QTB reconstruction and MCL reconstruction. Any accompanying intraarticular injuries such as meniscal lesions will be addressed as well. 17 patients will be included in this arm - this number was calculated and rounded up as a mean of number patients from studies of Alm et al. 2021 (17 patients in ACLR+MCLR group), Lee et al. 2020 (10 patients in ACLR+MCLR group), Kitamura et al. 2013 (16 patients in ACLR+MCLR group), LaPrade et al. 2012 (8 patients in ACLR+MCLR group), Lind et al. 2009 (34 patients in ACLR+MCLR group) and Kim et al. 2008 (12 patients in ACLR+MCLR group). All above referenced studies apart from the study of LaPrade et al. were retrospective. Receives: Procedure: Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement

What is being measured

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

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: Before the surgery
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 3 month of the follow-up.
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 6 month of the follow-up.
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.
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.
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: Before the surgery
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 3 month of the follow-up.
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 6 month of the follow-up.
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.
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.

Timeline

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

31 Aug 202231 Dec 2025

First posted5 Aug 2022
Study start31 Aug 2022
Primary completion31 Dec 2025 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Collateral Ligament, Knee; Sprain (Strain), MedialStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 17 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05489627
Sponsor's protocol ID: 3-pro-ar-2022
Status last verified: Jul 2023
First submitted: 3 Aug 2022
Last updated: 24 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Malinowski K, Hermanowicz K, Goralczyk A, LaPrade RF. Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Instability of the Knee. Arthrosc Tech. 2019 Jul 18;8(8):e807-e814. doi: 10.1016/j.eats.2019.03.019. eCollection 2019 Aug.
PubMed 31700776
Alm L, Drenck TC, Frings J, Krause M, Korthaus A, Krukenberg A, Frosch KH, Akoto R. Lower Failure Rates and Improved Patient Outcome Due to Reconstruction of the MCL and Revision ACL Reconstruction in Chronic Medial Knee Instability. Orthop J Sports Med. 2021 Mar 15;9(3):2325967121989312. doi: 10.1177/2325967121989312. eCollection 2021 Mar.
PubMed 33796589
Lee DW, Kim JG. Anatomic medial complex reconstruction in serious medial knee instability results in excellent mid-term outcomes. Knee Surg Sports Traumatol Arthrosc. 2020 Mar;28(3):725-732. doi: 10.1007/s00167-019-05367-9. Epub 2019 Apr 17.
PubMed 30997548
Xu H, Kang K, Zhang J, Xin D, Liu W, Jin G, Dong J, Gao S. An anatomical-like triangular-vector ligament reconstruction for the medial collateral ligament and the posterior oblique ligament injury with single femoral tunnel: a retrospective study. J Orthop Surg Res. 2017 Jun 26;12(1):96. doi: 10.1186/s13018-017-0602-3.
PubMed 28651635
Kitamura N, Ogawa M, Kondo E, Kitayama S, Tohyama H, Yasuda K. A novel medial collateral ligament reconstruction procedure using semitendinosus tendon autograft in patients with multiligamentous knee injuries: clinical outcomes. Am J Sports Med. 2013 Jun;41(6):1274-81. doi: 10.1177/0363546513485716. Epub 2013 Apr 26.
PubMed 23625060
Laprade RF, Wijdicks CA. Surgical technique: development of an anatomic medial knee reconstruction. Clin Orthop Relat Res. 2012 Mar;470(3):806-14. doi: 10.1007/s11999-011-2061-1.
PubMed 21909850
Lind M, Jakobsen BW, Lund B, Hansen MS, Abdallah O, Christiansen SE. Anatomical reconstruction of the medial collateral ligament and posteromedial corner of the knee in patients with chronic medial collateral ligament instability. Am J Sports Med. 2009 Jun;37(6):1116-22. doi: 10.1177/0363546509332498. Epub 2009 Mar 31.
PubMed 19336612
Kim SJ, Lee DH, Kim TE, Choi NH. Concomitant reconstruction of the medial collateral and posterior oblique ligaments for medial instability of the knee. J Bone Joint Surg Br. 2008 Oct;90(10):1323-7. doi: 10.1302/0301-620X.90B10.20781.
PubMed 18827242

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Knee Instability
ClinicalTrials.gov ID: NCT05489627
Acronym / sponsor ID: 3-pro-ar-2022
Conditions: Collateral Ligament, Knee; Sprain (Strain), Medial, Anterior Cruciate Ligament Injuries
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 17 participants (estimated)
Lead sponsor: Artromedical Konrad Malinowski ClinicUniversity, hospital or other
Study start: 31 Aug 2022 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 5 Aug 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The primary outcome consists of The International Knee Documentation Committee Questionnaire (IKDC) and the Knee injury and Osteoarthritis Outcome Score (KOOS).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single Group: Clinical trials with a single arm.

Arm	Type	Receives
Main arm of the study	Experimental	Procedure: Medial Collateral Ligament Reconstruction With Anteromedial ReinforcementMedial knee instabilities will be addressed in this arm. Due to the fact that isolated injury of medial stabilizers of the knees is very rare, included will be patients with D concomitant ACL QTB reconstruction and MCL reconstruction. Any accompanying intraarticular injuries such as meniscal lesions will be addressed as well. 17 patients will be included in this arm - this number was calculated and rounded up as a mean of number patients from studies of Alm et al. 2021 (17 patients in ACLR+MCLR group), Lee et al. 2020 (10 patients in ACLR+MCLR group), Kitamura et al. 2013 (16 patients in ACLR+MCLR group), LaPrade et al. 2012 (8 patients in ACLR+MCLR group), Lind et al. 2009 (34 patients in ACLR+MCLR group) and Kim et al. 2008 (12 patients in ACLR+MCLR group). All above referenced studies apart from the study of LaPrade et al. were retrospective.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Symptomatic knee medial and anteromedial rotatory instability associated with anterior and rotatory instability after an MCL + ACL injury
Primary cases

Key exclusion criteria (8 listed)

Active inflammation of the knee
Revision cases
Additional PLC, PCL or PFJ injuries
fractures around the knee
removal of more than ½ of medial or lateral meniscus

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medial Collateral Ligament Reconstruction With Anteromedial ReinforcementMedial knee instabilities will be addressed in this arm as described in the published technique: K. Malinowski, K. Hermanowicz, A. Góralczyk, R.F. LaPrade, Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Instability of the Knee, Arthrosc. Tech. 8 (2019) e807-e814. https://doi.org/10.1016/j.eats.2019.03.019. Due to the fact that isolated injury of medial stabilizers of the knees is very rare, included will be patients with concomitant ACL QTB reconstruction and abovedescribed MCL reconstruction. Any accompanying intraarticular injuries such as meniscal lesions will be addressed as well.	Procedure or surgery	Main arm of the study

Primary outcome

The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Time frame: Before the surgery
Min of 0 max of 87 points, higher scores mean a better outcome
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Time frame: At the 3 month of the follow-up.
Min of 0 max of 87 points, higher scores mean a better outcome
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Time frame: At the 6 month of the follow-up.
Min of 0 max of 87 points, higher scores mean a better outcome
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Time frame: At the 12 month of the follow-up.
Min of 0 max of 87 points, higher scores mean a better outcome
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Time frame: At the 24 month of the follow-up.
Min of 0 max of 87 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Time frame: Before the surgery
Min of 0 max of 100 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Time frame: At the 3 month of the follow-up.
Min of 0 max of 100 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Time frame: At the 6 month of the follow-up.
Min of 0 max of 100 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Time frame: At the 12 month of the follow-up.
Min of 0 max of 100 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Time frame: At the 24 month of the follow-up.
Min of 0 max of 100 points, higher scores mean a better outcome

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
Background: PubMed 31700776Malinowski K, Hermanowicz K, Goralczyk A, LaPrade RF. Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Instability of the Knee. Arthrosc Tech. 2019 Jul 18;8(8):e807-e814. doi: 10.1016/j.eats.2019.03.019. eCollection 2019 Aug.
Background: PubMed 33796589Alm L, Drenck TC, Frings J, Krause M, Korthaus A, Krukenberg A, Frosch KH, Akoto R. Lower Failure Rates and Improved Patient Outcome Due to Reconstruction of the MCL and Revision ACL Reconstruction in Chronic Medial Knee Instability. Orthop J Sports Med. 2021 Mar 15;9(3):2325967121989312. doi: 10.1177/2325967121989312. eCollection 2021 Mar.
Background: PubMed 30997548Lee DW, Kim JG. Anatomic medial complex reconstruction in serious medial knee instability results in excellent mid-term outcomes. Knee Surg Sports Traumatol Arthrosc. 2020 Mar;28(3):725-732. doi: 10.1007/s00167-019-05367-9. Epub 2019 Apr 17.
Background: PubMed 28651635Xu H, Kang K, Zhang J, Xin D, Liu W, Jin G, Dong J, Gao S. An anatomical-like triangular-vector ligament reconstruction for the medial collateral ligament and the posterior oblique ligament injury with single femoral tunnel: a retrospective study. J Orthop Surg Res. 2017 Jun 26;12(1):96. doi: 10.1186/s13018-017-0602-3.
Background: PubMed 23625060Kitamura N, Ogawa M, Kondo E, Kitayama S, Tohyama H, Yasuda K. A novel medial collateral ligament reconstruction procedure using semitendinosus tendon autograft in patients with multiligamentous knee injuries: clinical outcomes. Am J Sports Med. 2013 Jun;41(6):1274-81. doi: 10.1177/0363546513485716. Epub 2013 Apr 26.
Background: PubMed 21909850Laprade RF, Wijdicks CA. Surgical technique: development of an anatomic medial knee reconstruction. Clin Orthop Relat Res. 2012 Mar;470(3):806-14. doi: 10.1007/s11999-011-2061-1.
Background: PubMed 19336612Lind M, Jakobsen BW, Lund B, Hansen MS, Abdallah O, Christiansen SE. Anatomical reconstruction of the medial collateral ligament and posteromedial corner of the knee in patients with chronic medial collateral ligament instability. Am J Sports Med. 2009 Jun;37(6):1116-22. doi: 10.1177/0363546509332498. Epub 2009 Mar 31.
Background: PubMed 18827242Kim SJ, Lee DH, Kim TE, Choi NH. Concomitant reconstruction of the medial collateral and posterior oblique ligaments for medial instability of the knee. J Bone Joint Surg Br. 2008 Oct;90(10):1323-7. doi: 10.1302/0301-620X.90B10.20781.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Konrad Malinowski, MD PhD contact

+48 509812212

malwin8@wp.pl

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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 24 Jul 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?

The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC) (time frame: Before the surgery). The study lists 10 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 NCT05489627, which also lists 8 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 24 Jul 2023.