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Anterior Cruciate Ligament InjuriesNCT05701579

Assessment of Anterior Cruciate Ligament (ACL) Degeneratio Mucosa Treatment

An observational study of Anterior Cruciate Ligament Injuries, run by Artromedical Konrad Malinowski Clinic at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Anterior Cruciate Ligament (ACL) Degeneratio Mucosa is a condition resulting from mucoid degeneration of ACL. Exact etiology is unknown, however ACL Degeneratio Mucosa impairs everyday functioning. Read more about this study

Who is it for?
Any age
Conditions the study is for
Anterior Cruciate Ligament Injuries
What is being tested?
ACL "decompression"
Type of treatment
Surgery or procedure
How many people
10 participants
Where
1 sitePoland
Study dates
1 Jul 2022to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with ACL degeneratio mucosa decided to undergo a surgical treatment

Who may be able to join

  • patients with ACL degeneratio mucosa decided to undergo a surgical treatment
  • range of motion impairment caused by mucoid or cystic changes in ACL confirmed by MRI

Who cannot join

  • non-adherence to the study protocol
  • active knee inflammation
  • range of motion impairment due to other extra- and intra-articular reasons

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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 (ACL) Degeneratio Mucosa is a condition resulting from mucoid degeneration of ACL. Exact etiology is unknown, however ACL Degeneratio Mucosa impairs everyday functioning. In the literature there were some reports of treatment by ACL excision and subsequent reconstruction, however such treatment brings risk of deteriorated function. In this study the investigator will evaluate the technique of ACL "decompression" by the means of longitudinal incisions and evacuation of extrafibrous mucoid tissue.

Being tested
ACL "decompression"
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.

  • ACL "decompression"Procedure or surgery

    The technique of ACL "decompression" by the means of longitudinal incisions and evacuation of extrafibrous mucoid tissue.

Study groups in NCT05701579
Study groupRoleWhat they receive
Patients with ACL Degeneratio MucosaPatients with ACL Degeneratio Mucosa
Receives: Procedure: ACL "decompression"

What is being measured

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

  1. Range of motion

    Range of motion assessed by the means of goniometer

    Measured: At the 12 month of the follow-up

  2. Range of motion

    Range of motion assessed by the means of goniometer

    Measured: At the 24 month of the follow-up

  3. Knee anterior translatory stability

    Knee stability assessed by the means of Rollimeter-aided Lachman test - results will be presented in milimeters.

    Measured: At the 12 month of the follow-up

  4. Knee anterior translatory stability

    Knee stability assessed by the means of Rollimeter-aided Lachman test - results will be presented in milimeters.

    Measured: At the 24 month of the follow-up

  5. Knee anterolateral rotational stability

    Knee stability assessed by the means of pivot-shift test - results will be presented in grades

    Measured: At the 24 month of the follow-up

Secondary outcomes (4)

  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 (KOOS)

    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 (KOOS)

    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.

  1. First posted27 Jan 2023
  2. Study start1 Jul 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05701579
Sponsor's protocol ID
1-pro-ar-2023
Status last verified
Jan 2023
First submitted
6 Jan 2023
Last updated
27 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Gersing AS, Schwaiger BJ, Nevitt MC, Joseph GB, Feuerriegel G, Jungmann PM, Guimaraes JB, Facchetti L, McCulloch CE, Makowski MR, Link TM. Anterior cruciate ligament abnormalities are associated with accelerated progression of knee joint degeneration in knees with and without structural knee joint abnormalities: 96-month data from the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2021 Jul;29(7):995-1005. doi: 10.1016/j.joca.2021.03.011. Epub 2021 Mar 26.

    PubMed 33775919

  • Lintz F, Pujol N, Boisrenoult P, Bargoin K, Beaufils P, Dejour D. Anterior cruciate ligament mucoid degeneration: a review of the literature and management guidelines. Knee Surg Sports Traumatol Arthrosc. 2011 Aug;19(8):1326-33. doi: 10.1007/s00167-011-1433-0. Epub 2011 Feb 18.

    PubMed 21331652

  • Sweed T, Mussa M, El-Bakoury A, Geutjens G, Metcalfe A. Management of mucoid degeneration of the anterior cruciate ligament: a systematic review. Knee Surg Relat Res. 2021 Aug 21;33(1):26. doi: 10.1186/s43019-021-00110-6.

    PubMed 34419162

  • Lee JW, Ahn JT, Gwak HG, Lee SH. Clinical Outcomes of Arthroscopic Notchplasty and Partial Resection for Mucoid Degeneration of the Anterior Cruciate Ligament. J Clin Med. 2021 Jan 16;10(2):315. doi: 10.3390/jcm10020315.

    PubMed 33467062

Questions about this trial

What is this clinical trial studying?

An observational study of 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 3 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: looking for participants now, as of the sponsor's last update on 27 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?

This study is still under way. Results are not available in the source record yet.

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?

Range of motion (time frame: At the 12 month of the follow-up). The study lists 5 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 NCT05701579, which also lists 4 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 27 Jan 2023.

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